Olmesartan medoxomil, amlodipine and hydrochlorothiazide
- Product NDC
- 31722-892
- 11-digit product format
- 317220892
- Labeler code
- 31722
- Product ID
- 31722-892_47b1c419-e608-66b1-e063-6394a90ae253
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olmesartan medoxomil, amlodipine and hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA209242
- Marketing category
- ANDA
- Marketing start
- 2025-10-06
- Substance
- AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
- Active strength
- 5; 12.5; 20 mg/1; mg/1; mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], 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
- Olmesartan medoxomil, amlodipine and hydrochlorothiazide
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMLODIPINE BESYLATE | 5 mg/1 |
| HYDROCHLOROTHIAZIDE | 12.5 mg/1 |
| OLMESARTAN MEDOXOMIL | 20 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 6M97XTV3HD, 864V2Q084H, 0J48LPH2TH |
| Rxcui | 999967, 999986, 999991, 999996, 1000001 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 31722-892-30 | Olmesartan medoxomil, amlodipine and hydrochlorothiazide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 1 | |
| 31722-892-31 | Olmesartan medoxomil, amlodipine and hydrochlorothiazide | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | 1 | |
| 31722-892-32 | Olmesartan medoxomil, amlodipine and hydrochlorothiazide | 10 in 1 CARTON | TABLET, FILM COATED | 10 | 1 | |
| 31722-892-90 | Olmesartan medoxomil, amlodipine and hydrochlorothiazide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 999967 | olmesartan medoxomil 20 MG / amLODIPine 5 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | 45e975ff-07b1-411a-96ee-a011d1619b1e | 1 |
| 999986 | olmesartan medoxomil 40 MG / amLODIPine 10 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | 45e975ff-07b1-411a-96ee-a011d1619b1e | 1 |
| 999991 | olmesartan medoxomil 40 MG / amLODIPine 10 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | 45e975ff-07b1-411a-96ee-a011d1619b1e | 1 |
| 999996 | olmesartan medoxomil 40 MG / amLODIPine 5 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | 45e975ff-07b1-411a-96ee-a011d1619b1e | 1 |
| 1000001 | olmesartan medoxomil 40 MG / amLODIPine 5 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | 45e975ff-07b1-411a-96ee-a011d1619b1e | 1 |
| 999986 | amlodipine 10 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet | SCD | 45e975ff-07b1-411a-96ee-a011d1619b1e | 1 |
| 999991 | amlodipine 10 MG / hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral Tablet | SCD | 45e975ff-07b1-411a-96ee-a011d1619b1e | 1 |
| 999967 | amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral Tablet | SCD | 45e975ff-07b1-411a-96ee-a011d1619b1e | 1 |
| 999996 | amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet | SCD | 45e975ff-07b1-411a-96ee-a011d1619b1e | 1 |
| 1000001 | amlodipine 5 MG / hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral Tablet | SCD | 45e975ff-07b1-411a-96ee-a011d1619b1e | 1 |
| 999991 | amlodipine (as amlodipine besilate) 10 MG / HCTZ 25 MG / olmesartan medoxomil 40 MG Oral Tablet | SY | 45e975ff-07b1-411a-96ee-a011d1619b1e | 1 |
| 1000001 | amlodipine (as amlodipine besilate) 5 MG / HCTZ 25 MG / olmesartan medoxomil 40 MG Oral Tablet | SY | 45e975ff-07b1-411a-96ee-a011d1619b1e | 1 |
| 999996 | amlodipine (as amlodipine besilate) 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet | SY | 45e975ff-07b1-411a-96ee-a011d1619b1e | 1 |
| 999986 | amlodipine (as amlodipine besylate) 10 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet | SY | 45e975ff-07b1-411a-96ee-a011d1619b1e | 1 |
| 999967 | amlodipine (as amlodipine besylate) 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral Tablet | SY | 45e975ff-07b1-411a-96ee-a011d1619b1e | 1 |
| 999986 | Amlodipine 10 MG / HCTZ 12.5 MG / Olmesartan medoxomil 40 MG Oral Tablet | SY | 45e975ff-07b1-411a-96ee-a011d1619b1e | 1 |
| 999991 | Amlodipine 10 MG / HCTZ 25 MG / Olmesartan medoxomil 40 MG Oral Tablet | SY | 45e975ff-07b1-411a-96ee-a011d1619b1e | 1 |
| 999967 | Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 20 MG Oral Tablet | SY | 45e975ff-07b1-411a-96ee-a011d1619b1e | 1 |
| 999996 | Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 40 MG Oral Tablet | SY | 45e975ff-07b1-411a-96ee-a011d1619b1e | 1 |
| 1000001 | Amlodipine 5 MG / HCTZ 25 MG / Olmesartan medoxomil 40 MG Oral Tablet | SY | 45e975ff-07b1-411a-96ee-a011d1619b1e | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 31722-892-30 | 31722089230 | 30 TABLET, FILM COATED in 1 BOTTLE (31722-892-30) | 2025-10-06 | No | No | Current | |
| 31722-892-31 | 31722089231 | 10 in 1 BLISTER PACK | Historical | ||||
| 31722-892-32 | 31722089232 | 10 BLISTER PACK in 1 CARTON (31722-892-32) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-892-31) | 10 blister pack | 2025-10-06 | No | No | Current |
| 31722-892-90 | 31722089290 | 90 TABLET, FILM COATED in 1 BOTTLE (31722-892-90) | 2025-10-06 | No | No | Current |