olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide
- Product NDC
- 70436-014
- 11-digit product format
- 704360014
- Labeler code
- 70436
- Product ID
- 70436-014_d306cb9e-4244-49dd-9297-9cb6ca69cae9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Slate Run Pharmaceuticals, LLC
- Application
- ANDA210718
- Marketing category
- ANDA
- Marketing start
- 2025-05-15
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide
- Listing expiration
- 2026-12-31
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, 0J48LPH2TH, 864V2Q084H |
| Rxcui | 999967, 999986, 999991, 999996, 1000001 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70436-014-04 | olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 3 | |
| 70436-014-06 | olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70436-014-04 | EA - Each | 70436-014 | fc7a3f64-7fec-44ad-ad0c-07ca0158e72a | 1 | 2025-12-16 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70436-014 | OLMESARTAN MEDOXOMIL AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SLATE RUN PHARMACEUTICALS, LLC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20250529_a469adff-25a6-4983-b471-60924d920a86.zip |
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 | a469adff-25a6-4983-b471-60924d920a86 | 3 |
| 999986 | olmesartan medoxomil 40 MG / amLODIPine 10 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | a469adff-25a6-4983-b471-60924d920a86 | 3 |
| 999991 | olmesartan medoxomil 40 MG / amLODIPine 10 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | a469adff-25a6-4983-b471-60924d920a86 | 3 |
| 999996 | olmesartan medoxomil 40 MG / amLODIPine 5 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | a469adff-25a6-4983-b471-60924d920a86 | 3 |
| 1000001 | olmesartan medoxomil 40 MG / amLODIPine 5 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | a469adff-25a6-4983-b471-60924d920a86 | 3 |
| 999986 | amlodipine 10 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet | SCD | a469adff-25a6-4983-b471-60924d920a86 | 3 |
| 999991 | amlodipine 10 MG / hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral Tablet | SCD | a469adff-25a6-4983-b471-60924d920a86 | 3 |
| 999967 | amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral Tablet | SCD | a469adff-25a6-4983-b471-60924d920a86 | 3 |
| 999996 | amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet | SCD | a469adff-25a6-4983-b471-60924d920a86 | 3 |
| 1000001 | amlodipine 5 MG / hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral Tablet | SCD | a469adff-25a6-4983-b471-60924d920a86 | 3 |
| 999991 | amlodipine (as amlodipine besilate) 10 MG / HCTZ 25 MG / olmesartan medoxomil 40 MG Oral Tablet | SY | a469adff-25a6-4983-b471-60924d920a86 | 3 |
| 1000001 | amlodipine (as amlodipine besilate) 5 MG / HCTZ 25 MG / olmesartan medoxomil 40 MG Oral Tablet | SY | a469adff-25a6-4983-b471-60924d920a86 | 3 |
| 999996 | amlodipine (as amlodipine besilate) 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet | SY | a469adff-25a6-4983-b471-60924d920a86 | 3 |
| 999986 | amlodipine (as amlodipine besylate) 10 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet | SY | a469adff-25a6-4983-b471-60924d920a86 | 3 |
| 999967 | amlodipine (as amlodipine besylate) 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral Tablet | SY | a469adff-25a6-4983-b471-60924d920a86 | 3 |
| 999986 | Amlodipine 10 MG / HCTZ 12.5 MG / Olmesartan medoxomil 40 MG Oral Tablet | SY | a469adff-25a6-4983-b471-60924d920a86 | 3 |
| 999991 | Amlodipine 10 MG / HCTZ 25 MG / Olmesartan medoxomil 40 MG Oral Tablet | SY | a469adff-25a6-4983-b471-60924d920a86 | 3 |
| 999967 | Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 20 MG Oral Tablet | SY | a469adff-25a6-4983-b471-60924d920a86 | 3 |
| 999996 | Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 40 MG Oral Tablet | SY | a469adff-25a6-4983-b471-60924d920a86 | 3 |
| 1000001 | Amlodipine 5 MG / HCTZ 25 MG / Olmesartan medoxomil 40 MG Oral Tablet | SY | a469adff-25a6-4983-b471-60924d920a86 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70436-014-04 | 70436001404 | 30 TABLET, FILM COATED in 1 BOTTLE (70436-014-04) | 2025-05-15 | No | No | Historical | |
| 70436-014-06 | 70436001406 | 90 TABLET, FILM COATED in 1 BOTTLE (70436-014-06) | 2025-05-15 | No | No | Historical | |
| 70436-014-80 | 70436001480 | 5 VIAL, SINGLE-DOSE in 1 BOX (70436-014-80) > 2 mL in 1 VIAL, SINGLE-DOSE | 2021-09-01 | 0000-00-00 | No | No | Current |
| 70436-014-81 | 70436001481 | 5 VIAL, SINGLE-DOSE in 1 BOX (70436-014-81) > 2 mL in 1 VIAL, SINGLE-DOSE | 2021-09-23 | 0000-00-00 | No | No | Current |