Amlodipine Besylate
- Product NDC
- 12634-562
- 11-digit product format
- 126340562
- Labeler code
- 12634
- Product ID
- 12634-562_46cafc45-78b0-38a1-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Apotheca Inc.
- Application
- ANDA203245
- Marketing category
- ANDA
- Marketing start
- 2014-03-03
- Marketing end
- 0000-00-00
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 12634-562-00 | Amlodipine Besylate | 10 in 1 BOTTLE | TABLET | 10 | 1 | |
| 12634-562-01 | Amlodipine Besylate | 100 in 1 BOTTLE | TABLET | 100 | 1 | |
| 12634-562-09 | Amlodipine Besylate | 35 in 1 BOTTLE | TABLET | 35 | 1 | |
| 12634-562-12 | Amlodipine Besylate | 120 in 1 BOTTLE | TABLET | 120 | 1 | |
| 12634-562-18 | Amlodipine Besylate | 180 in 1 BOTTLE | TABLET | 180 | 1 | |
| 12634-562-40 | Amlodipine Besylate | 40 in 1 BOTTLE | TABLET | 40 | 1 | |
| 12634-562-42 | Amlodipine Besylate | 42 in 1 BOTTLE | TABLET | 42 | 1 | |
| 12634-562-45 | Amlodipine Besylate | 45 in 1 BOTTLE | TABLET | 45 | 1 | |
| 12634-562-50 | Amlodipine Besylate | 50 in 1 BOTTLE | TABLET | 50 | 1 | |
| 12634-562-52 | Amlodipine Besylate | 12 in 1 BLISTER PACK | TABLET | 12 | 1 | |
| 12634-562-54 | Amlodipine Besylate | 14 in 1 BLISTER PACK | TABLET | 14 | 1 | |
| 12634-562-57 | Amlodipine Besylate | 20 in 1 BLISTER PACK | TABLET | 20 | 1 | |
| 12634-562-59 | Amlodipine Besylate | 30 in 1 BLISTER PACK | TABLET | 30 | 1 | |
| 12634-562-60 | Amlodipine Besylate | 60 in 1 BOTTLE | TABLET | 60 | 1 | |
| 12634-562-61 | Amlodipine Besylate | 10 in 1 BLISTER PACK | TABLET | 10 | 1 | |
| 12634-562-63 | Amlodipine Besylate | 3 in 1 BLISTER PACK | TABLET | 3 | 1 | |
| 12634-562-66 | Amlodipine Besylate | 6 in 1 BLISTER PACK | TABLET | 6 | 1 | |
| 12634-562-67 | Amlodipine Besylate | 7 in 1 BLISTER PACK | TABLET | 7 | 1 | |
| 12634-562-69 | Amlodipine Besylate | 9 in 1 BLISTER PACK | TABLET | 9 | 1 | |
| 12634-562-71 | Amlodipine Besylate | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 12634-562-74 | Amlodipine Besylate | 24 in 1 BOTTLE | TABLET | 24 | 1 | |
| 12634-562-78 | Amlodipine Besylate | 28 in 1 BOTTLE | TABLET | 28 | 1 | |
| 12634-562-79 | Amlodipine Besylate | 25 in 1 BOTTLE | TABLET | 25 | 1 | |
| 12634-562-80 | Amlodipine Besylate | 20 in 1 BOTTLE | TABLET | 20 | 1 | |
| 12634-562-81 | Amlodipine Besylate | 21 in 1 BOTTLE | TABLET | 21 | 1 | |
| 12634-562-82 | Amlodipine Besylate | 12 in 1 BOTTLE | TABLET | 12 | 1 | |
| 12634-562-84 | Amlodipine Besylate | 14 in 1 BOTTLE | TABLET | 14 | 1 | |
| 12634-562-85 | Amlodipine Besylate | 15 in 1 BOTTLE | TABLET | 15 | 1 | |
| 12634-562-90 | Amlodipine Besylate | 90 in 1 BOTTLE | TABLET | 90 | 1 | |
| 12634-562-91 | Amlodipine Besylate | 1 in 1 BLISTER PACK | TABLET | 1 | 1 | |
| 12634-562-92 | Amlodipine Besylate | 2 in 1 BOTTLE | TABLET | 2 | 1 | |
| 12634-562-93 | Amlodipine Besylate | 3 in 1 BOTTLE | TABLET | 3 | 1 | |
| 12634-562-94 | Amlodipine Besylate | 4 in 1 BOTTLE | TABLET | 4 | 1 | |
| 12634-562-95 | Amlodipine Besylate | 5 in 1 BOTTLE | TABLET | 5 | 1 | |
| 12634-562-96 | Amlodipine Besylate | 6 in 1 BOTTLE | TABLET | 6 | 1 | |
| 12634-562-97 | Amlodipine Besylate | 7 in 1 BOTTLE | TABLET | 7 | 1 | |
| 12634-562-98 | Amlodipine Besylate | 8 in 1 BOTTLE | TABLET | 8 | 1 | |
| 12634-562-99 | Amlodipine Besylate | 9 in 1 BOTTLE | TABLET | 9 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197361 | amLODIPine besylate 5 MG Oral Tablet | PSN | 46cafc45-78af-38a1-e054-00144ff88e88 | 1 |
| 197361 | amlodipine 5 MG Oral Tablet | SCD | 46cafc45-78af-38a1-e054-00144ff88e88 | 1 |
| 197361 | amlodipine (as amlodipine besylate) 5 MG Oral Tablet | SY | 46cafc45-78af-38a1-e054-00144ff88e88 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 12634-562-00 | 12634056200 | 10 TABLET in 1 BOTTLE (12634-562-00) | 10 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-01 | 12634056201 | 100 TABLET in 1 BOTTLE (12634-562-01) | 100 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-09 | 12634056209 | 35 TABLET in 1 BOTTLE (12634-562-09) | 35 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-12 | 12634056212 | 120 TABLET in 1 BOTTLE (12634-562-12) | 120 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-18 | 12634056218 | 180 TABLET in 1 BOTTLE (12634-562-18) | 180 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-40 | 12634056240 | 40 TABLET in 1 BOTTLE (12634-562-40) | 40 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-42 | 12634056242 | 42 TABLET in 1 BOTTLE (12634-562-42) | 42 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-45 | 12634056245 | 45 TABLET in 1 BOTTLE (12634-562-45) | 45 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-50 | 12634056250 | 50 TABLET in 1 BOTTLE (12634-562-50) | 50 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-52 | 12634056252 | 12 TABLET in 1 BLISTER PACK (12634-562-52) | 12 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-54 | 12634056254 | 14 TABLET in 1 BLISTER PACK (12634-562-54) | 14 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-57 | 12634056257 | 20 TABLET in 1 BLISTER PACK (12634-562-57) | 20 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-59 | 12634056259 | 30 TABLET in 1 BLISTER PACK (12634-562-59) | 30 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-60 | 12634056260 | 60 TABLET in 1 BOTTLE (12634-562-60) | 60 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-61 | 12634056261 | 10 TABLET in 1 BLISTER PACK (12634-562-61) | 10 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-63 | 12634056263 | 3 TABLET in 1 BLISTER PACK (12634-562-63) | 3 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-66 | 12634056266 | 6 TABLET in 1 BLISTER PACK (12634-562-66) | 6 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-67 | 12634056267 | 7 TABLET in 1 BLISTER PACK (12634-562-67) | 7 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-69 | 12634056269 | 9 TABLET in 1 BLISTER PACK (12634-562-69) | 9 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-71 | 12634056271 | 30 TABLET in 1 BOTTLE (12634-562-71) | 30 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-74 | 12634056274 | 24 TABLET in 1 BOTTLE (12634-562-74) | 24 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-78 | 12634056278 | 28 TABLET in 1 BOTTLE (12634-562-78) | 28 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-79 | 12634056279 | 25 TABLET in 1 BOTTLE (12634-562-79) | 25 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-80 | 12634056280 | 20 TABLET in 1 BOTTLE (12634-562-80) | 20 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-81 | 12634056281 | 21 TABLET in 1 BOTTLE (12634-562-81) | 21 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-82 | 12634056282 | 12 TABLET in 1 BOTTLE (12634-562-82) | 12 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-84 | 12634056284 | 14 TABLET in 1 BOTTLE (12634-562-84) | 14 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-85 | 12634056285 | 15 TABLET in 1 BOTTLE (12634-562-85) | 15 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-90 | 12634056290 | 90 TABLET in 1 BOTTLE (12634-562-90) | 90 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-91 | 12634056291 | 1 TABLET in 1 BLISTER PACK (12634-562-91) | 1 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-92 | 12634056292 | 2 TABLET in 1 BOTTLE (12634-562-92) | 2 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-93 | 12634056293 | 3 TABLET in 1 BOTTLE (12634-562-93) | 3 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-94 | 12634056294 | 4 TABLET in 1 BOTTLE (12634-562-94) | 4 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-95 | 12634056295 | 5 TABLET in 1 BOTTLE (12634-562-95) | 5 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-96 | 12634056296 | 6 TABLET in 1 BOTTLE (12634-562-96) | 6 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-97 | 12634056297 | 7 TABLET in 1 BOTTLE (12634-562-97) | 7 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-98 | 12634056298 | 8 TABLET in 1 BOTTLE (12634-562-98) | 8 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-562-99 | 12634056299 | 9 TABLET in 1 BOTTLE (12634-562-99) | 9 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |