Amlodipine Besylate
- Product NDC
- 12634-599
- 11-digit product format
- 126340599
- Labeler code
- 12634
- Product ID
- 12634-599_46c9e361-39e2-6f5e-e054-00144ff8d46c
- 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
- 3 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 |
|---|---|---|---|---|---|---|
| 12634-599-00 | Amlodipine Besylate | 10 in 1 BOTTLE | TABLET | 10 | 2 | |
| 12634-599-01 | Amlodipine Besylate | 100 in 1 BOTTLE | TABLET | 100 | 2 | |
| 12634-599-09 | Amlodipine Besylate | 35 in 1 BOTTLE | TABLET | 35 | 2 | |
| 12634-599-12 | Amlodipine Besylate | 120 in 1 BOTTLE | TABLET | 120 | 2 | |
| 12634-599-18 | Amlodipine Besylate | 180 in 1 BOTTLE | TABLET | 180 | 2 | |
| 12634-599-40 | Amlodipine Besylate | 40 in 1 BOTTLE | TABLET | 40 | 2 | |
| 12634-599-42 | Amlodipine Besylate | 42 in 1 BOTTLE | TABLET | 42 | 2 | |
| 12634-599-45 | Amlodipine Besylate | 45 in 1 BOTTLE | TABLET | 45 | 2 | |
| 12634-599-50 | Amlodipine Besylate | 50 in 1 BOTTLE | TABLET | 50 | 2 | |
| 12634-599-52 | Amlodipine Besylate | 12 in 1 BLISTER PACK | TABLET | 12 | 2 | |
| 12634-599-54 | Amlodipine Besylate | 14 in 1 BLISTER PACK | TABLET | 14 | 2 | |
| 12634-599-57 | Amlodipine Besylate | 20 in 1 BLISTER PACK | TABLET | 20 | 2 | |
| 12634-599-59 | Amlodipine Besylate | 30 in 1 BLISTER PACK | TABLET | 30 | 2 | |
| 12634-599-60 | Amlodipine Besylate | 60 in 1 BOTTLE | TABLET | 60 | 2 | |
| 12634-599-61 | Amlodipine Besylate | 10 in 1 BLISTER PACK | TABLET | 10 | 2 | |
| 12634-599-63 | Amlodipine Besylate | 3 in 1 BLISTER PACK | TABLET | 3 | 2 | |
| 12634-599-66 | Amlodipine Besylate | 6 in 1 BLISTER PACK | TABLET | 6 | 2 | |
| 12634-599-67 | Amlodipine Besylate | 7 in 1 BLISTER PACK | TABLET | 7 | 2 | |
| 12634-599-69 | Amlodipine Besylate | 9 in 1 BLISTER PACK | TABLET | 9 | 2 | |
| 12634-599-71 | Amlodipine Besylate | 30 in 1 BOTTLE | TABLET | 30 | 2 | |
| 12634-599-74 | Amlodipine Besylate | 24 in 1 BOTTLE | TABLET | 24 | 2 | |
| 12634-599-78 | Amlodipine Besylate | 28 in 1 BOTTLE | TABLET | 28 | 2 | |
| 12634-599-79 | Amlodipine Besylate | 25 in 1 BOTTLE | TABLET | 25 | 2 | |
| 12634-599-80 | Amlodipine Besylate | 20 in 1 BOTTLE | TABLET | 20 | 2 | |
| 12634-599-81 | Amlodipine Besylate | 21 in 1 BOTTLE | TABLET | 21 | 2 | |
| 12634-599-82 | Amlodipine Besylate | 12 in 1 BOTTLE | TABLET | 12 | 2 | |
| 12634-599-84 | Amlodipine Besylate | 14 in 1 BOTTLE | TABLET | 14 | 2 | |
| 12634-599-85 | Amlodipine Besylate | 15 in 1 BOTTLE | TABLET | 15 | 2 | |
| 12634-599-90 | Amlodipine Besylate | 90 in 1 BOTTLE | TABLET | 90 | 2 | |
| 12634-599-91 | Amlodipine Besylate | 1 in 1 BLISTER PACK | TABLET | 1 | 2 | |
| 12634-599-92 | Amlodipine Besylate | 2 in 1 BOTTLE | TABLET | 2 | 2 | |
| 12634-599-93 | Amlodipine Besylate | 3 in 1 BOTTLE | TABLET | 3 | 2 | |
| 12634-599-94 | Amlodipine Besylate | 4 in 1 BOTTLE | TABLET | 4 | 2 | |
| 12634-599-95 | Amlodipine Besylate | 5 in 1 BOTTLE | TABLET | 5 | 2 | |
| 12634-599-96 | Amlodipine Besylate | 6 in 1 BOTTLE | TABLET | 6 | 2 | |
| 12634-599-97 | Amlodipine Besylate | 7 in 1 BOTTLE | TABLET | 7 | 2 | |
| 12634-599-98 | Amlodipine Besylate | 8 in 1 BOTTLE | TABLET | 8 | 2 | |
| 12634-599-99 | Amlodipine Besylate | 9 in 1 BOTTLE | TABLET | 9 | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308136 | amLODIPine besylate 2.5 MG Oral Tablet | PSN | 46c9e361-39e1-6f5e-e054-00144ff8d46c | 2 |
| 308136 | amlodipine 2.5 MG Oral Tablet | SCD | 46c9e361-39e1-6f5e-e054-00144ff8d46c | 2 |
| 308136 | amlodipine (as amlodipine besylate) 2.5 MG Oral Tablet | SY | 46c9e361-39e1-6f5e-e054-00144ff8d46c | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 12634-599-00 | 12634059900 | 10 TABLET in 1 BOTTLE (12634-599-00) | 10 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-01 | 12634059901 | 100 TABLET in 1 BOTTLE (12634-599-01) | 100 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-09 | 12634059909 | 35 TABLET in 1 BOTTLE (12634-599-09) | 35 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-12 | 12634059912 | 120 TABLET in 1 BOTTLE (12634-599-12) | 120 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-18 | 12634059918 | 180 TABLET in 1 BOTTLE (12634-599-18) | 180 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-40 | 12634059940 | 40 TABLET in 1 BOTTLE (12634-599-40) | 40 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-42 | 12634059942 | 42 TABLET in 1 BOTTLE (12634-599-42) | 42 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-45 | 12634059945 | 45 TABLET in 1 BOTTLE (12634-599-45) | 45 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-50 | 12634059950 | 50 TABLET in 1 BOTTLE (12634-599-50) | 50 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-52 | 12634059952 | 12 TABLET in 1 BLISTER PACK (12634-599-52) | 12 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-54 | 12634059954 | 14 TABLET in 1 BLISTER PACK (12634-599-54) | 14 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-57 | 12634059957 | 20 TABLET in 1 BLISTER PACK (12634-599-57) | 20 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-59 | 12634059959 | 30 TABLET in 1 BLISTER PACK (12634-599-59) | 30 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-60 | 12634059960 | 60 TABLET in 1 BOTTLE (12634-599-60) | 60 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-61 | 12634059961 | 10 TABLET in 1 BLISTER PACK (12634-599-61) | 10 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-63 | 12634059963 | 3 TABLET in 1 BLISTER PACK (12634-599-63) | 3 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-66 | 12634059966 | 6 TABLET in 1 BLISTER PACK (12634-599-66) | 6 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-67 | 12634059967 | 7 TABLET in 1 BLISTER PACK (12634-599-67) | 7 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-69 | 12634059969 | 9 TABLET in 1 BLISTER PACK (12634-599-69) | 9 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-71 | 12634059971 | 30 TABLET in 1 BOTTLE (12634-599-71) | 30 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-74 | 12634059974 | 24 TABLET in 1 BOTTLE (12634-599-74) | 24 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-78 | 12634059978 | 28 TABLET in 1 BOTTLE (12634-599-78) | 28 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-79 | 12634059979 | 25 TABLET in 1 BOTTLE (12634-599-79) | 25 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-80 | 12634059980 | 20 TABLET in 1 BOTTLE (12634-599-80) | 20 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-81 | 12634059981 | 21 TABLET in 1 BOTTLE (12634-599-81) | 21 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-82 | 12634059982 | 12 TABLET in 1 BOTTLE (12634-599-82) | 12 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-84 | 12634059984 | 14 TABLET in 1 BOTTLE (12634-599-84) | 14 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-85 | 12634059985 | 15 TABLET in 1 BOTTLE (12634-599-85) | 15 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-90 | 12634059990 | 90 TABLET in 1 BOTTLE (12634-599-90) | 90 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-91 | 12634059991 | 1 TABLET in 1 BLISTER PACK (12634-599-91) | 1 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-92 | 12634059992 | 2 TABLET in 1 BOTTLE (12634-599-92) | 2 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-93 | 12634059993 | 3 TABLET in 1 BOTTLE (12634-599-93) | 3 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-94 | 12634059994 | 4 TABLET in 1 BOTTLE (12634-599-94) | 4 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-95 | 12634059995 | 5 TABLET in 1 BOTTLE (12634-599-95) | 5 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-96 | 12634059996 | 6 TABLET in 1 BOTTLE (12634-599-96) | 6 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-97 | 12634059997 | 7 TABLET in 1 BOTTLE (12634-599-97) | 7 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-98 | 12634059998 | 8 TABLET in 1 BOTTLE (12634-599-98) | 8 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 12634-599-99 | 12634059999 | 9 TABLET in 1 BOTTLE (12634-599-99) | 9 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |