OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE
- Product NDC
- 42571-245
- 11-digit product format
- 425710245
- Labeler code
- 42571
- Product ID
- 42571-245_44b62ded-18e8-b2e8-e063-6294a90ac180
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olmesartan Medoxomil, Amlodipine besylate and Hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Micro Labs Limited
- Application
- ANDA207437
- Marketing category
- ANDA
- Marketing start
- 2026-03-01
- 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, AMLODIPINE 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 | 0J48LPH2TH, 864V2Q084H, 6M97XTV3HD |
| Rxcui | 999967, 999986, 999991, 999996, 1000001 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42571-245-05 | OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 5 | |
| 42571-245-10 | OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 5 | |
| 42571-245-30 | OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 5 | |
| 42571-245-90 | OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 5 |
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 | 9fb71df8-f70f-47dc-9465-8d8748261caf | 5 |
| 999986 | olmesartan medoxomil 40 MG / amLODIPine 10 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | 9fb71df8-f70f-47dc-9465-8d8748261caf | 5 |
| 999991 | olmesartan medoxomil 40 MG / amLODIPine 10 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | 9fb71df8-f70f-47dc-9465-8d8748261caf | 5 |
| 999996 | olmesartan medoxomil 40 MG / amLODIPine 5 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | 9fb71df8-f70f-47dc-9465-8d8748261caf | 5 |
| 1000001 | olmesartan medoxomil 40 MG / amLODIPine 5 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | 9fb71df8-f70f-47dc-9465-8d8748261caf | 5 |
| 999986 | amlodipine 10 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet | SCD | 9fb71df8-f70f-47dc-9465-8d8748261caf | 5 |
| 999991 | amlodipine 10 MG / hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral Tablet | SCD | 9fb71df8-f70f-47dc-9465-8d8748261caf | 5 |
| 999967 | amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral Tablet | SCD | 9fb71df8-f70f-47dc-9465-8d8748261caf | 5 |
| 999996 | amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet | SCD | 9fb71df8-f70f-47dc-9465-8d8748261caf | 5 |
| 1000001 | amlodipine 5 MG / hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral Tablet | SCD | 9fb71df8-f70f-47dc-9465-8d8748261caf | 5 |
| 999991 | amlodipine (as amlodipine besilate) 10 MG / HCTZ 25 MG / olmesartan medoxomil 40 MG Oral Tablet | SY | 9fb71df8-f70f-47dc-9465-8d8748261caf | 5 |
| 1000001 | amlodipine (as amlodipine besilate) 5 MG / HCTZ 25 MG / olmesartan medoxomil 40 MG Oral Tablet | SY | 9fb71df8-f70f-47dc-9465-8d8748261caf | 5 |
| 999996 | amlodipine (as amlodipine besilate) 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet | SY | 9fb71df8-f70f-47dc-9465-8d8748261caf | 5 |
| 999986 | amlodipine (as amlodipine besylate) 10 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet | SY | 9fb71df8-f70f-47dc-9465-8d8748261caf | 5 |
| 999967 | amlodipine (as amlodipine besylate) 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral Tablet | SY | 9fb71df8-f70f-47dc-9465-8d8748261caf | 5 |
| 999986 | Amlodipine 10 MG / HCTZ 12.5 MG / Olmesartan medoxomil 40 MG Oral Tablet | SY | 9fb71df8-f70f-47dc-9465-8d8748261caf | 5 |
| 999991 | Amlodipine 10 MG / HCTZ 25 MG / Olmesartan medoxomil 40 MG Oral Tablet | SY | 9fb71df8-f70f-47dc-9465-8d8748261caf | 5 |
| 999967 | Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 20 MG Oral Tablet | SY | 9fb71df8-f70f-47dc-9465-8d8748261caf | 5 |
| 999996 | Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 40 MG Oral Tablet | SY | 9fb71df8-f70f-47dc-9465-8d8748261caf | 5 |
| 1000001 | Amlodipine 5 MG / HCTZ 25 MG / Olmesartan medoxomil 40 MG Oral Tablet | SY | 9fb71df8-f70f-47dc-9465-8d8748261caf | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 42571-245-05 | 42571024505 | 500 TABLET, FILM COATED in 1 BOTTLE (42571-245-05) | 2026-03-01 | No | No | Historical |
| 42571-245-10 | 42571024510 | 1000 TABLET, FILM COATED in 1 BOTTLE (42571-245-10) | 2026-03-01 | No | No | Historical |
| 42571-245-30 | 42571024530 | 30 TABLET, FILM COATED in 1 BOTTLE (42571-245-30) | 2026-03-01 | No | No | Historical |
| 42571-245-90 | 42571024590 | 90 TABLET, FILM COATED in 1 BOTTLE (42571-245-90) | 2026-03-01 | No | No | Historical |