Irbesartan and Hydrochlorothiazide
- Product NDC
- 65862-630
- 11-digit product format
- 658620630
- Labeler code
- 65862
- Product ID
- 65862-630_6f7c3d7b-9b7c-447e-8763-f68a55ce4b91
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan and Hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA203630
- Marketing category
- ANDA
- Marketing start
- 2013-02-22
- Substance
- HYDROCHLOROTHIAZIDE; IRBESARTAN
- Active strength
- 12.5; 300 mg/1; mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Irbesartan and Hydrochlorothiazide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCHLOROTHIAZIDE | 12.5 mg/1 |
| IRBESARTAN | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | J0E2756Z7N, 0J48LPH2TH |
| Rxcui | 310792, 310793, 485471 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65862-630-05 | Irbesartan and Hydrochlorothiazide | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 14 |
| 65862-630-30 | Irbesartan and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 14 |
| 65862-630-90 | Irbesartan and Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 14 |
| 65862-630-99 | Irbesartan and Hydrochlorothiazide | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HYDROCHLOROTHIAZIDE | ACTIVE INGREDIENT | 0J48LPH2TH | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | |
| IRBESARTAN | ACTIVE INGREDIENT | J0E2756Z7N | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | |
| HYDROCHLOROTHIAZIDE | ACTIVE MOIETY | 0J48LPH2TH | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | |
| IRBESARTAN | ACTIVE MOIETY | J0E2756Z7N | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | |
| HYPROMELLOSE 2910 (15 MPA.S) | INACTIVE INGREDIENT | 36SFW2JZ0W | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | |
| POLYETHYLENE GLYCOL 3000 | INACTIVE INGREDIENT | SA1B764746 | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-630 | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 12 | Current NDC, Legacy NDC, 4 package rows | 20240518_466dd0d2-9815-4c3e-b66b-d0732b3ba8e9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65862-630-05 | 65862063005 | 500 TABLET, FILM COATED in 1 BOTTLE (65862-630-05) | 2013-02-22 | 0000-00-00 | No | No | Current |
| 65862-630-22 | 65862063022 | 2000 TABLET, FILM COATED in 1 BAG (65862-630-22) | 22-FEB-13 | | | | Current |
| 65862-630-30 | 65862063030 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-630-30) | 2013-02-22 | 0000-00-00 | No | No | Current |
| 65862-630-90 | 65862063090 | 90 TABLET, FILM COATED in 1 BOTTLE (65862-630-90) | 2013-02-22 | 0000-00-00 | No | No | Current |
| 65862-630-99 | 65862063099 | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-630-99) | 2013-02-22 | 0000-00-00 | No | No | Current |