AMLODIPINE BESYLATE
- Product NDC
- 72789-260
- 11-digit product format
- 727890260
- Labeler code
- 72789
- Product ID
- 72789-260_41d6707a-c54e-5987-e063-6294a90ab185
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMLODIPINE BESYLATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA078414
- Marketing category
- ANDA
- Marketing start
- 2021-10-01
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 2.5 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
- Brand name suffix
- 2.5 mg
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMLODIPINE BESYLATE | 2.5 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 864V2Q084H |
| Rxcui | 197361, 308135, 308136 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fa898d56-9495-d6f0-309b-68a5d8e3914a | Product name | 4 | 20260305 |
| c19ec24d-2c40-4b8d-7c20-500ffa3660a1 | Product name | 3 | 20260303 |
| b15e9aa6-d523-ca97-480e-570e0543a342 | Product name | 4 | 20251024 |
| 265792b3-b999-c010-7364-a7db20b9d4d9 | Product name | 5 | 20250515 |
| 14c2c15b-f823-4ada-a40e-a440544294dc | Product name | 1 | 20221207 |
| a72887ef-d675-499f-af4b-78688f6855cd | Product name | 1 | 20191002 |
| a4484670-2869-6416-f6ff-03b1b3cbd1b0 | Product name | 2 | 20190415 |
| 4a27501f-a987-48a5-99b4-e983d4744d76 | Product name | 7 | 20181211 |
| 18600d07-613d-bf9c-2711-fe40c06f3393 | Product name | 5 | 20180703 |
| bded1554-44de-900a-5297-403365d6d4b2 | Product name | 3 | 20170110 |
| 1f1c6e4b-bbad-4649-afd1-7a1d671db4b1 | Product name | 1 | 20150316 |
| 63ab5fbf-2a6b-c41d-051a-39e845d718b1 | Product name | 1 | 20140508 |
| 7613b1a5-acb6-4e5e-6048-c44deeeb1212 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72789-260-90 | AMLODIPINE BESYLATE2.5 mg | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | 17 | |
| 72789-260-95 | AMLODIPINE BESYLATE2.5 mg | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | 17 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72789-260-90 | EA - Each | 72789-260 | 1199ddb8-7409-40e1-bd80-6dfedd973316 | 1 | 2022-08-04 |
| 72789-260-95 | EA - Each | 72789-260 | 51420a1e-fd7a-43fc-bf0e-aa1ee9336621 | 1 | 2022-08-04 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 72789-260 | AMLODIPINE BESYLATE 5 MG (AMLODIPINE BESYLATE) TABLET AMLODIPINE BESYLATE 2.5 MG (AMLODIPINE BESYLATE) TABLET AMLODIPINE BESYLATE 10 MG (AMLODIPINE BESYLATE) TABLET [PD-RX PHARMACEUTICALS, INC.] | 16 | Current NDC, Legacy NDC, 2 package rows | 20250121_1080fcea-a5da-499d-a855-690c13559071.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308135 | amLODIPine besylate 10 MG Oral Tablet | PSN | 1080fcea-a5da-499d-a855-690c13559071 | 17 |
| 308136 | amLODIPine besylate 2.5 MG Oral Tablet | PSN | 1080fcea-a5da-499d-a855-690c13559071 | 17 |
| 197361 | amLODIPine besylate 5 MG Oral Tablet | PSN | 1080fcea-a5da-499d-a855-690c13559071 | 17 |
| 308135 | amlodipine 10 MG Oral Tablet | SCD | 1080fcea-a5da-499d-a855-690c13559071 | 17 |
| 308136 | amlodipine 2.5 MG Oral Tablet | SCD | 1080fcea-a5da-499d-a855-690c13559071 | 17 |
| 197361 | amlodipine 5 MG Oral Tablet | SCD | 1080fcea-a5da-499d-a855-690c13559071 | 17 |
| 308135 | amlodipine (as amlodipine besylate) 10 MG Oral Tablet | SY | 1080fcea-a5da-499d-a855-690c13559071 | 17 |
| 308136 | amlodipine (as amlodipine besylate) 2.5 MG Oral Tablet | SY | 1080fcea-a5da-499d-a855-690c13559071 | 17 |
| 197361 | amlodipine (as amlodipine besylate) 5 MG Oral Tablet | SY | 1080fcea-a5da-499d-a855-690c13559071 | 17 |
| 308136 | amLODIPine besylate 2.5 MG Oral Tablet | PSN | 132c078d-7d31-a6f2-e063-6294a90af095 | 1 |
| 308136 | amlodipine 2.5 MG Oral Tablet | SCD | 132c078d-7d31-a6f2-e063-6294a90af095 | 1 |
| 308136 | amlodipine (as amlodipine besylate) 2.5 MG Oral Tablet | SY | 132c078d-7d31-a6f2-e063-6294a90af095 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 72789-260-90 | 72789026090 | 90 TABLET in 1 BOTTLE, PLASTIC (72789-260-90) | 90 tablet | 2022-07-15 | 0000-00-00 | No | No | Current |
| 72789-260-95 | 72789026095 | 1000 TABLET in 1 BOTTLE, PLASTIC (72789-260-95) | 1000 tablet | 2022-07-15 | 0000-00-00 | No | No | Current |