![TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET [CADILA HEALTHCARE LIMITED]](https://medic.hrt.org//dailymed/images/cbcd600a-4499-4d54-9b50-171a51e8966f/d4460402-1bfe-4301-b07d-04eda802a256-04.jpg)
![TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET [CADILA HEALTHCARE LIMITED]](https://medic.hrt.org//dailymed/images/cbcd600a-4499-4d54-9b50-171a51e8966f/d4460402-1bfe-4301-b07d-04eda802a256-05.jpg)
![TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET [CADILA HEALTHCARE LIMITED]](https://medic.hrt.org//dailymed/images/cbcd600a-4499-4d54-9b50-171a51e8966f/d4460402-1bfe-4301-b07d-04eda802a256-06.jpg)
| NDC | 70771-1123-2, 70771-1123-3, 70771-1123-8, 70771-1123-9, 70771-1124-2, 70771-1124-3, 70771-1124-8, 70771-1124-9, 70771-1125-2, 70771-1125-3, 70771-1125-8, 70771-1125-9 |
| Set ID | cbcd600a-4499-4d54-9b50-171a51e8966f |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Cadila Healthcare Limited |
| Generic Name | |
| Product Class | Angiotensin 2 Receptor Blocker |
| Product Number | |
| Application Number | ANDA204221 |
- SPL UNCLASSIFIED SECTION
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1123-9 in bottle of 90 tablets
Telmisartan and Hydrochlorthaizide Tablets USP, 40 mg/12.5 mg
Rx only
90 tablets
NDC 70771-1124-9 in bottle of 90 tablets
Telmisartan and Hydrochlorthaizide Tablets USP, 80 mg/12.5 mg
Rx only
90 tablets
NDC 70771-1125-9 in bottle of 90 tablets
Telmisartan and Hydrochlorthaizide Tablets USP, 80 mg/25 mg
Rx only
90 tablets
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INGREDIENTS AND APPEARANCE
TELMISARTAN AND HYDROCHLOROTHIAZIDE
telmisartan and hydrochlorothiazide tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1123 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ) TELMISARTAN 40 mg HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE 12.5 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (UNII: 2S7830E561) FERRIC OXIDE RED (UNII: 1K09F3G675) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) MEGLUMINE (UNII: 6HG8UB2MUY) POVIDONE (UNII: FZ989GH94E) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) SORBITOL (UNII: 506T60A25R) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color BROWN (Mottled Light brown to Mottled Brown) , WHITE (WHITE TO OFF WHITE) Score no score Shape OVAL (Oblong Shaped) Size 15mm Flavor Imprint Code 513 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1123-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 10/12/2017 2 NDC:70771-1123-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 10/12/2017 3 NDC:70771-1123-8 3 in 1 CARTON 10/12/2017 3 NDC:70771-1123-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204221 10/12/2017 TELMISARTAN AND HYDROCHLOROTHIAZIDE
telmisartan and hydrochlorothiazide tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1124 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ) TELMISARTAN 80 mg HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE 12.5 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (UNII: 2S7830E561) FERRIC OXIDE RED (UNII: 1K09F3G675) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) MEGLUMINE (UNII: 6HG8UB2MUY) POVIDONE (UNII: FZ989GH94E) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) SORBITOL (UNII: 506T60A25R) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color BROWN (Mottled Light brown to Mottled Brown) , WHITE (WHITE TO OFF WHITE) Score no score Shape OVAL (Oblong Shaped) Size 17mm Flavor Imprint Code 514 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1124-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 10/12/2017 2 NDC:70771-1124-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 10/12/2017 3 NDC:70771-1124-8 3 in 1 CARTON 10/12/2017 3 NDC:70771-1124-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204221 10/12/2017 TELMISARTAN AND HYDROCHLOROTHIAZIDE
telmisartan and hydrochlorothiazide tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1125 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ) TELMISARTAN 80 mg HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE 25 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (UNII: 2S7830E561) FERRIC OXIDE RED (UNII: 1K09F3G675) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) MEGLUMINE (UNII: 6HG8UB2MUY) POVIDONE (UNII: FZ989GH94E) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) SORBITOL (UNII: 506T60A25R) TALC (UNII: 7SEV7J4R1U) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Product Characteristics Color BROWN (Mottled Light brown to Mottled Brown) , YELLOW (YELLOW) Score no score Shape OVAL (Oblong Shaped) Size 17mm Flavor Imprint Code 515 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1125-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 10/12/2017 2 NDC:70771-1125-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 10/12/2017 3 NDC:70771-1125-8 3 in 1 CARTON 10/12/2017 3 NDC:70771-1125-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204221 10/12/2017 Labeler - Cadila Healthcare Limited (918596198) Registrant - Cadila Healthcare Limited (918596198) Establishment Name Address ID/FEI Business Operations Cadila Healthcare Limited 918596198 ANALYSIS(70771-1123, 70771-1124, 70771-1125) , MANUFACTURE(70771-1123, 70771-1124, 70771-1125)