Amlodipine Besylate
- Product NDC
- 43063-564
- 11-digit product format
- 430630564
- Labeler code
- 43063
- Product ID
- 43063-564_4139529b-8bda-e979-e063-6394a90a3773
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA078925
- Marketing category
- ANDA
- Marketing start
- 2010-10-20
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 5 mg/1
- Pharmacologic classes
- 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 Besylate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMLODIPINE BESYLATE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 864V2Q084H |
| Rxcui | 197361 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43063-564-30 | Amlodipine Besylate | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 33 |
| 43063-564-90 | Amlodipine Besylate | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 33 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AMLODIPINE BESYLATE | ACTIVE INGREDIENT | 864V2Q084H | AMLODIPINE BESYLATE TABLET [PD-RX PHARMACEUTICALS, INC.] | 8 | |
| AMLODIPINE | ACTIVE MOIETY | 1J444QC288 | AMLODIPINE BESYLATE TABLET [PD-RX PHARMACEUTICALS, INC.] | 8 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | AMLODIPINE BESYLATE TABLET [PD-RX PHARMACEUTICALS, INC.] | 8 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMLODIPINE BESYLATE TABLET [PD-RX PHARMACEUTICALS, INC.] | 8 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMLODIPINE BESYLATE TABLET [PD-RX PHARMACEUTICALS, INC.] | 8 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMLODIPINE BESYLATE TABLET [PD-RX PHARMACEUTICALS, INC.] | 8 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | AMLODIPINE BESYLATE TABLET [PD-RX PHARMACEUTICALS, INC.] | 8 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-564 | AMLODIPINE BESYLATE TABLET [PD-RX PHARMACEUTICALS, INC.] | 32 | Current NDC, Legacy NDC, 2 package rows | 20240919_ac0dd8fb-ebe1-4d02-bd0d-4f979c6e3608.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 |
|---|
| 43063-564-30 | 43063056430 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-564-30) | 30 tablet | 2015-03-09 | 0000-00-00 | No | No | Current |
| 43063-564-90 | 43063056490 | 90 TABLET in 1 BOTTLE, PLASTIC (43063-564-90) | 90 tablet | 2015-03-09 | 0000-00-00 | No | No | Current |