Amlodipine Besylate
- Product NDC
- 68180-719
- 11-digit product format
- 681800719
- Labeler code
- 68180
- Product ID
- 68180-719_99ab6bdc-6207-4886-8f2f-f0ed62622b89
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA078043
- Marketing category
- ANDA
- Marketing start
- 2018-10-31
- Marketing end
- 0000-00-00
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 3 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|---|---|---|---|---|---|
| 68180-719-03 | Amlodipine Besylate | 1000 in 1 BOTTLE | TABLET | 1000 | 29 | |
| 68180-719-09 | Amlodipine Besylate | 90 in 1 BOTTLE | TABLET | 90 | 29 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68180-719-09 | EA - Each | 68180-719 | 67c933da-9bbf-4dca-8155-1a3ba7b6dd3c | 1 | 2018-11-06 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| AMLODIPINE BESYLATE | ACTIVE INGREDIENT | 864V2Q084H | AMLODIPINE BESYLATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 9 | |
| AMLODIPINE | ACTIVE MOIETY | 1J444QC288 | AMLODIPINE BESYLATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 9 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMLODIPINE BESYLATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 9 | |
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | AMLODIPINE BESYLATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 9 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMLODIPINE BESYLATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 9 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | AMLODIPINE BESYLATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 9 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308135 | amLODIPine besylate 10 MG Oral Tablet | PSN | 003dd1ec-16f8-4f96-b6a8-c4689d35892a | 29 |
| 308136 | amLODIPine besylate 2.5 MG Oral Tablet | PSN | 003dd1ec-16f8-4f96-b6a8-c4689d35892a | 29 |
| 197361 | amLODIPine besylate 5 MG Oral Tablet | PSN | 003dd1ec-16f8-4f96-b6a8-c4689d35892a | 29 |
| 308135 | amlodipine 10 MG Oral Tablet | SCD | 003dd1ec-16f8-4f96-b6a8-c4689d35892a | 29 |
| 308136 | amlodipine 2.5 MG Oral Tablet | SCD | 003dd1ec-16f8-4f96-b6a8-c4689d35892a | 29 |
| 197361 | amlodipine 5 MG Oral Tablet | SCD | 003dd1ec-16f8-4f96-b6a8-c4689d35892a | 29 |
| 308135 | amlodipine (as amlodipine besylate) 10 MG Oral Tablet | SY | 003dd1ec-16f8-4f96-b6a8-c4689d35892a | 29 |
| 308136 | amlodipine (as amlodipine besylate) 2.5 MG Oral Tablet | SY | 003dd1ec-16f8-4f96-b6a8-c4689d35892a | 29 |
| 197361 | amlodipine (as amlodipine besylate) 5 MG Oral Tablet | SY | 003dd1ec-16f8-4f96-b6a8-c4689d35892a | 29 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68180-719-03 | 68180071903 | 1000 TABLET in 1 BOTTLE (68180-719-03) | 1000 tablet | 2022-02-01 | 0000-00-00 | No | No | Current |
| 68180-719-09 | 68180071909 | 90 TABLET in 1 BOTTLE (68180-719-09) | 90 tablet | 2018-10-31 | 0000-00-00 | No | No | Current |