Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide
- Product NDC
- 0093-5004
- 11-digit product format
- 000935004
- Labeler code
- 0093
- Product ID
- 0093-5004_a035edd9-948f-4168-b74b-9961a2cb219a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA202491
- Marketing category
- ANDA
- Marketing start
- 2016-11-14
- Substance
- AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
- Active strength
- 5; 25; 40 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMLODIPINE BESYLATE | 5 mg/1 |
| HYDROCHLOROTHIAZIDE | 25 mg/1 |
| OLMESARTAN MEDOXOMIL | 40 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 0J48LPH2TH, 864V2Q084H, 6M97XTV3HD |
| Rxcui | 999967, 999986, 999991, 999996, 1000001 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0093-5004-56 | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 14 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0093-5004-56 | EA - Each | 0093-5004 | 2d34e66e-e73d-47f7-a45d-89352a251b66 | 1 | 2016-12-07 |
| 0093-5004-98 | EA - Each | 0093-5004 | 8f448ae0-dcdc-41a9-8945-f4b7cbfa2144 | 1 | 2016-12-07 |
DailyMed Dashboard NDC Coverage#
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 | 5c128ef2-60a6-40f3-b37f-ee139fe27987 | 14 |
| 999986 | olmesartan medoxomil 40 MG / amLODIPine 10 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | 5c128ef2-60a6-40f3-b37f-ee139fe27987 | 14 |
| 999991 | olmesartan medoxomil 40 MG / amLODIPine 10 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | 5c128ef2-60a6-40f3-b37f-ee139fe27987 | 14 |
| 999996 | olmesartan medoxomil 40 MG / amLODIPine 5 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | 5c128ef2-60a6-40f3-b37f-ee139fe27987 | 14 |
| 1000001 | olmesartan medoxomil 40 MG / amLODIPine 5 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | 5c128ef2-60a6-40f3-b37f-ee139fe27987 | 14 |
| 999986 | amlodipine 10 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet | SCD | 5c128ef2-60a6-40f3-b37f-ee139fe27987 | 14 |
| 999991 | amlodipine 10 MG / hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral Tablet | SCD | 5c128ef2-60a6-40f3-b37f-ee139fe27987 | 14 |
| 999967 | amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral Tablet | SCD | 5c128ef2-60a6-40f3-b37f-ee139fe27987 | 14 |
| 999996 | amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet | SCD | 5c128ef2-60a6-40f3-b37f-ee139fe27987 | 14 |
| 1000001 | amlodipine 5 MG / hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral Tablet | SCD | 5c128ef2-60a6-40f3-b37f-ee139fe27987 | 14 |
| 999991 | amlodipine (as amlodipine besilate) 10 MG / HCTZ 25 MG / olmesartan medoxomil 40 MG Oral Tablet | SY | 5c128ef2-60a6-40f3-b37f-ee139fe27987 | 14 |
| 1000001 | amlodipine (as amlodipine besilate) 5 MG / HCTZ 25 MG / olmesartan medoxomil 40 MG Oral Tablet | SY | 5c128ef2-60a6-40f3-b37f-ee139fe27987 | 14 |
| 999996 | amlodipine (as amlodipine besilate) 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet | SY | 5c128ef2-60a6-40f3-b37f-ee139fe27987 | 14 |
| 999986 | amlodipine (as amlodipine besylate) 10 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet | SY | 5c128ef2-60a6-40f3-b37f-ee139fe27987 | 14 |
| 999967 | amlodipine (as amlodipine besylate) 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral Tablet | SY | 5c128ef2-60a6-40f3-b37f-ee139fe27987 | 14 |
| 999986 | Amlodipine 10 MG / HCTZ 12.5 MG / Olmesartan medoxomil 40 MG Oral Tablet | SY | 5c128ef2-60a6-40f3-b37f-ee139fe27987 | 14 |
| 999991 | Amlodipine 10 MG / HCTZ 25 MG / Olmesartan medoxomil 40 MG Oral Tablet | SY | 5c128ef2-60a6-40f3-b37f-ee139fe27987 | 14 |
| 999967 | Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 20 MG Oral Tablet | SY | 5c128ef2-60a6-40f3-b37f-ee139fe27987 | 14 |
| 999996 | Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 40 MG Oral Tablet | SY | 5c128ef2-60a6-40f3-b37f-ee139fe27987 | 14 |
| 1000001 | Amlodipine 5 MG / HCTZ 25 MG / Olmesartan medoxomil 40 MG Oral Tablet | SY | 5c128ef2-60a6-40f3-b37f-ee139fe27987 | 14 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0093-5004-56 | 00093500456 | 30 TABLET, FILM COATED in 1 BOTTLE (0093-5004-56) | 2016-11-14 | 0000-00-00 | No | No | Current |