Amlodipine and Valsartan
- Product NDC
- 64380-214
- 11-digit product format
- 643800214
- Labeler code
- 64380
- Product ID
- 64380-214_1da81b6e-f1da-46de-8396-592cd855801b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amlodipine and valsartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- ANDA090011
- Marketing category
- ANDA
- Marketing start
- 2022-10-24
- Substance
- AMLODIPINE; VALSARTAN
- Active strength
- 5; 160 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]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amlodipine and Valsartan
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMLODIPINE | 5 mg/1 |
| VALSARTAN | 160 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1J444QC288, 80M03YXJ7I |
| Rxcui | 722126, 722131, 722134, 722137 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64380-214-01 | Amlodipine and Valsartan | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 6 |
| 64380-214-02 | Amlodipine and Valsartan | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64380-214 | AMLODIPINE AND VALSARTAN TABLET [STRIDES PHARMA SCIENCE LIMITED] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241023_2094f801-4e92-47cd-9487-98f4043abd3c.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 |
|---|
| 64380-214-01 | 64380021401 | 30 TABLET in 1 BOTTLE, PLASTIC (64380-214-01) | 30 tablet | 2022-10-24 | 0000-00-00 | No | No | Current |
| 64380-214-02 | 64380021402 | 90 TABLET in 1 BOTTLE, PLASTIC (64380-214-02) | 90 tablet | 2022-10-24 | 0000-00-00 | No | No | Current |