Irbesartan and Hydrochlorothiazide
- Product NDC
- 29300-215
- 11-digit product format
- 293000215
- Labeler code
- 29300
- Product ID
- 29300-215_a2e7c9d1-50c4-4a14-8dd5-8dfc6d63a29a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan and Hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Unichem Pharmaceuticals (USA), Inc.
- Application
- ANDA207018
- Marketing category
- ANDA
- Marketing start
- 2017-09-19
- 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
- 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 | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0J48LPH2TH, J0E2756Z7N |
| Rxcui | 310792, 310793 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 29300-215-10 | Irbesartan and Hydrochlorothiazide | 1000 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 1000 | | 12 |
| 29300-215-13 | Irbesartan and Hydrochlorothiazide | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 12 |
| 29300-215-19 | Irbesartan and Hydrochlorothiazide | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 29300-215 | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.] | 10 | Current NDC, Legacy NDC, 3 package rows | 20221217_181324c5-256f-4570-a0bb-8bc908deb2e2.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 |
|---|
| 29300-215-10 | 29300021510 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-215-10) | 2018-03-31 | 0000-00-00 | No | No | Current |
| 29300-215-13 | 29300021513 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-215-13) | 2018-03-31 | 0000-00-00 | No | No | Current |
| 29300-215-19 | 29300021519 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-215-19) | 2018-03-31 | 0000-00-00 | No | No | Current |