Irbesartan and Hydrochlorothiazide
- Product NDC
- 33342-058
- 11-digit product format
- 333420058
- Labeler code
- 33342
- Product ID
- 33342-058_f2ef667a-4871-4f28-a0b3-3f79fbbe180c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan and Hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA202414
- Marketing category
- ANDA
- Marketing start
- 2012-09-27
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 33342-058-06 | Irbesartan and Hydrochlorothiazide | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 15 |
| 33342-058-06 | Irbesartan and Hydrochlorothiazide | 3 in 1 CARTON | TABLET, FILM COATED | 3 | | 15 |
| 33342-058-07 | Irbesartan and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 15 |
| 33342-058-10 | Irbesartan and Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 15 |
| 33342-058-15 | Irbesartan and Hydrochlorothiazide | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 15 |
| 33342-058-39 | Irbesartan and Hydrochlorothiazide | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 15 |
| 33342-058-39 | Irbesartan and Hydrochlorothiazide | 9 in 1 CARTON | TABLET, FILM COATED | 9 | | 15 |
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 [MACLEODS PHARMACEUTICALS LIMITED] | 5 | |
| IRBESARTAN | ACTIVE INGREDIENT | J0E2756Z7N | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 5 | |
| HYDROCHLOROTHIAZIDE | ACTIVE MOIETY | 0J48LPH2TH | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 5 | |
| IRBESARTAN | ACTIVE MOIETY | J0E2756Z7N | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 5 | |
| CARBOXYMETHYLCELLULOSE CALCIUM | INACTIVE INGREDIENT | UTY7PDF93L | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 5 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 5 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 5 | |
| HYPROMELLOSE 2910 (15 MPA.S) | INACTIVE INGREDIENT | 36SFW2JZ0W | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 5 | |
| POLYETHYLENE GLYCOL 3000 | INACTIVE INGREDIENT | SA1B764746 | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 5 | |
| POVIDONE K29/32 | INACTIVE INGREDIENT | 390RMW2PEQ | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 5 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 5 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 5 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33342-058 | IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 14 | Current NDC, Legacy NDC, 7 package rows | 20220723_1898f438-4571-4aab-ae06-9bf1aabf0486.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 33342-058-06 | 33342005806 | 3 BLISTER PACK in 1 CARTON (33342-058-06) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 3 blister pack | 2012-09-27 | 0000-00-00 | No | No | Current |
| 33342-058-07 | 33342005807 | 30 TABLET, FILM COATED in 1 BOTTLE (33342-058-07) | | 2012-09-27 | 0000-00-00 | No | No | Current |
| 33342-058-10 | 33342005810 | 90 TABLET, FILM COATED in 1 BOTTLE (33342-058-10) | | 2012-09-27 | 0000-00-00 | No | No | Current |
| 33342-058-15 | 33342005815 | 500 TABLET, FILM COATED in 1 BOTTLE (33342-058-15) | | 2012-09-27 | 0000-00-00 | No | No | Current |
| 33342-058-39 | 33342005839 | 9 BLISTER PACK in 1 CARTON (33342-058-39) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 9 blister pack | 2012-09-27 | 0000-00-00 | No | No | Current |