Irbesartan and Hydrochlorothiazide
- Product NDC
- 63629-7468
- 11-digit product format
- 636297468
- Labeler code
- 63629
- Product ID
- 63629-7468_9f27724f-cd5c-4885-aa5b-70896904d570
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan and Hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202414
- Marketing category
- ANDA
- Marketing start
- 2012-09-27
- 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 |
|---|---|
| HYDROCHLOROTHIAZIDE | 12.5 mg/1 |
| IRBESARTAN | 150 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 0J48LPH2TH, J0E2756Z7N |
| Rxcui | 310792 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63629-7468-1 | Irbesartan and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 7 | |
| 63629-7468-2 | Irbesartan and Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 7 | |
| 63629-7468-3 | Irbesartan and Hydrochlorothiazide | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | 7 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63629-7468 | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 6 | Current NDC, Legacy NDC, 3 package rows | 20220904_46d77ed8-ece2-4f51-b1a4-4a440e2dce2d.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310792 | irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | 46d77ed8-ece2-4f51-b1a4-4a440e2dce2d | 7 |
| 310792 | hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet | SCD | 46d77ed8-ece2-4f51-b1a4-4a440e2dce2d | 7 |
| 310792 | HCTZ 12.5 MG / irbesartan 150 MG Oral Tablet | SY | 46d77ed8-ece2-4f51-b1a4-4a440e2dce2d | 7 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63629-7468-1 | 63629746801 | 30 TABLET, FILM COATED in 1 BOTTLE (63629-7468-1) | 2019-02-12 | 0000-00-00 | No | No | Current |
| 63629-7468-2 | 63629746802 | 90 TABLET, FILM COATED in 1 BOTTLE (63629-7468-2) | 2017-11-20 | 0000-00-00 | No | No | Current |
| 63629-7468-3 | 63629746803 | 28 TABLET, FILM COATED in 1 BOTTLE (63629-7468-3) | 2022-09-02 | 0000-00-00 | No | No | Current |