Irbesartan and Hydrochlorothiazide
- Product NDC
- 0093-8238
- 11-digit product format
- 000938238
- Labeler code
- 0093
- Product ID
- 0093-8238_af80b0d1-ba9d-4d3c-849c-6c7c1a7cfade
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan and Hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA077369
- Marketing category
- ANDA
- Marketing start
- 2013-01-24
- Substance
- HYDROCHLOROTHIAZIDE; IRBESARTAN
- Active strength
- 12.5; 150 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Irbesartan and Hydrochlorothiazide
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCHLOROTHIAZIDE | 12.5 mg/1 |
| IRBESARTAN | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | J0E2756Z7N, 0J48LPH2TH |
| Rxcui | 310792, 310793 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0093-8238-56 | Irbesartan and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 16 |
| 0093-8238-98 | Irbesartan and Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 16 |
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 [TEVA PHARMACEUTICALS USA INC] | 4 | |
| IRBESARTAN | ACTIVE INGREDIENT | J0E2756Z7N | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| HYDROCHLOROTHIAZIDE | ACTIVE MOIETY | 0J48LPH2TH | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| IRBESARTAN | ACTIVE MOIETY | J0E2756Z7N | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| POLOXAMER 188 | INACTIVE INGREDIENT | LQA7B6G8JG | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-8238 | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] | 14 | Current NDC, Legacy NDC, 2 package rows | 20211203_83f4acc1-697a-4770-b554-1b9a8fb5de74.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 |
|---|
| 0093-8238-56 | 00093823856 | 30 TABLET, FILM COATED in 1 BOTTLE (0093-8238-56) | 2013-01-24 | 0000-00-00 | No | No | Current |
| 0093-8238-98 | 00093823898 | 90 TABLET, FILM COATED in 1 BOTTLE (0093-8238-98) | 2013-02-20 | 0000-00-00 | No | No | Current |