Amlodipine Besylate
- Product NDC
- 12634-600
- 11-digit product format
- 126340600
- Labeler code
- 12634
- Product ID
- 12634-600_368408e8-87e1-4092-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Apotheca Inc.
- Application
- ANDA077955
- Marketing category
- ANDA
- Marketing start
- 2011-01-01
- Marketing end
- 0000-00-00
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 10 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
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 12634-600 | I | Inactivated by FDA | 2026-08-17 | ||
| excluded package | package | 12634-600 | 12634-600-00 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-01 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-09 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-40 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-42 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-45 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-50 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-52 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-54 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-57 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-58 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-59 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-60 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-61 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-63 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-66 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-67 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-69 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-71 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-74 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-78 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-79 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-80 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-81 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-82 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-84 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-85 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-90 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-91 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-92 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-93 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-94 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-95 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-96 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-97 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-98 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 12634-600 | 12634-600-99 | I | Inactivated by FDA | 2026-08-17 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-99 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-58 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-66 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-91 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-94 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-80 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-59 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-09 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-67 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-52 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-69 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-90 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-96 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-98 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-40 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-00 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-78 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-57 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-82 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-42 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-45 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-60 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-79 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-63 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-81 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-93 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-97 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-71 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-54 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-61 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-95 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-50 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-92 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-74 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-84 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-600-85 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-600-99 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-600-58 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-600-66 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-600-91 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-600-94 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-600-80 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-600-59 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-600-09 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-600-67 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-600-52 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-600-69 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-600-90 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-600-96 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-600-98 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-600-40 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-600-00 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-600-78 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-600-57 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-600-82 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-600-42 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-600-45 | f5e01cc5f278… | a2eaf40c39c3… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077955-001 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-08-28 | |
| A077955-002 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-08-28 | |
| A077955-003 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-08-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077955-001 | AB |
| A077955-002 | AB |
| A077955-003 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A077955-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-08-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077955-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-08-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077955-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-08-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077955-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077955-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077955-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-08-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077955-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077955-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077955-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-08-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077955-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077955-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077955-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-08-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077955-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-08-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077955-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-08-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077955-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-08-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077955-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-08-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077955-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-08-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077955-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-08-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077955-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077955-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077955-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-08-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077955-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077955-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077955-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-08-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077955-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077955-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077955-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-08-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077955-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-08-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077955-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-08-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077955-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-08-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077955-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-08-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077955-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-08-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077955-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-08-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077955-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077955-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077955-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-08-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077955-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077955-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077955-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-08-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077955-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A077955-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077955-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077955-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A077955-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077955-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077955-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077955-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077955-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077955-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077955-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077955-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077955-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077955-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077955-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077955-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077955-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077955-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077955-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077955-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077955-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077955-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077955-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077955-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077955-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077955-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077955-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077955-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077955-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077955-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077955-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077955-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077955-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077955-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077955-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077955-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077955-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077955-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077955-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077955-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077955-001 | AB | 1 | 1e350fbaab3a… |
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 |
|---|---|---|---|---|---|---|
| 12634-600-00 | Amlodipine Besylate | 10 in 1 BOTTLE | TABLET | 10 | 1 | |
| 12634-600-01 | Amlodipine Besylate | 100 in 1 BOTTLE | TABLET | 100 | 1 | |
| 12634-600-09 | Amlodipine Besylate | 35 in 1 BOTTLE | TABLET | 35 | 1 | |
| 12634-600-40 | Amlodipine Besylate | 40 in 1 BOTTLE | TABLET | 40 | 1 | |
| 12634-600-42 | Amlodipine Besylate | 42 in 1 BOTTLE | TABLET | 42 | 1 | |
| 12634-600-45 | Amlodipine Besylate | 45 in 1 BOTTLE | TABLET | 45 | 1 | |
| 12634-600-50 | Amlodipine Besylate | 50 in 1 BOTTLE | TABLET | 50 | 1 | |
| 12634-600-52 | Amlodipine Besylate | 12 in 1 BLISTER PACK | TABLET | 12 | 1 | |
| 12634-600-54 | Amlodipine Besylate | 14 in 1 BLISTER PACK | TABLET | 14 | 1 | |
| 12634-600-57 | Amlodipine Besylate | 20 in 1 BLISTER PACK | TABLET | 20 | 1 | |
| 12634-600-58 | Amlodipine Besylate | 28 in 1 BLISTER PACK | TABLET | 28 | 1 | |
| 12634-600-59 | Amlodipine Besylate | 30 in 1 BLISTER PACK | TABLET | 30 | 1 | |
| 12634-600-60 | Amlodipine Besylate | 60 in 1 BOTTLE | TABLET | 60 | 1 | |
| 12634-600-61 | Amlodipine Besylate | 10 in 1 BLISTER PACK | TABLET | 10 | 1 | |
| 12634-600-63 | Amlodipine Besylate | 3 in 1 BLISTER PACK | TABLET | 3 | 1 | |
| 12634-600-66 | Amlodipine Besylate | 6 in 1 BLISTER PACK | TABLET | 6 | 1 | |
| 12634-600-67 | Amlodipine Besylate | 7 in 1 BLISTER PACK | TABLET | 7 | 1 | |
| 12634-600-69 | Amlodipine Besylate | 9 in 1 BLISTER PACK | TABLET | 9 | 1 | |
| 12634-600-71 | Amlodipine Besylate | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 12634-600-74 | Amlodipine Besylate | 24 in 1 BOTTLE | TABLET | 24 | 1 | |
| 12634-600-78 | Amlodipine Besylate | 28 in 1 BOTTLE | TABLET | 28 | 1 | |
| 12634-600-79 | Amlodipine Besylate | 25 in 1 BOTTLE | TABLET | 25 | 1 | |
| 12634-600-80 | Amlodipine Besylate | 20 in 1 BOTTLE | TABLET | 20 | 1 | |
| 12634-600-81 | Amlodipine Besylate | 21 in 1 BOTTLE | TABLET | 21 | 1 | |
| 12634-600-82 | Amlodipine Besylate | 12 in 1 BOTTLE | TABLET | 12 | 1 | |
| 12634-600-84 | Amlodipine Besylate | 14 in 1 BOTTLE | TABLET | 14 | 1 | |
| 12634-600-85 | Amlodipine Besylate | 15 in 1 BOTTLE | TABLET | 15 | 1 | |
| 12634-600-90 | Amlodipine Besylate | 90 in 1 BOTTLE | TABLET | 90 | 1 | |
| 12634-600-91 | Amlodipine Besylate | 1 in 1 BLISTER PACK | TABLET | 1 | 1 | |
| 12634-600-92 | Amlodipine Besylate | 2 in 1 BOTTLE | TABLET | 2 | 1 | |
| 12634-600-93 | Amlodipine Besylate | 3 in 1 BOTTLE | TABLET | 3 | 1 | |
| 12634-600-94 | Amlodipine Besylate | 4 in 1 BOTTLE | TABLET | 4 | 1 | |
| 12634-600-95 | Amlodipine Besylate | 5 in 1 BOTTLE | TABLET | 5 | 1 | |
| 12634-600-96 | Amlodipine Besylate | 6 in 1 BOTTLE | TABLET | 6 | 1 | |
| 12634-600-97 | Amlodipine Besylate | 7 in 1 BOTTLE | TABLET | 7 | 1 | |
| 12634-600-98 | Amlodipine Besylate | 8 in 1 BOTTLE | TABLET | 8 | 1 | |
| 12634-600-99 | Amlodipine Besylate | 9 in 1 BOTTLE | TABLET | 9 | 1 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Amlodipine Besylate | AMLODIPINE BESYLATE | Legacy Pharmaceutical Packaging, LLC | 2cdd0da9-eea6-45e0-b0b7-35413a168a4f | 2026-03-03 | Warnings, Adverse reactions | 077955 ANDA077955 |
| Amlodipine besylate | AMLODIPINE BESYLATE | Bryant Ranch Prepack | c3742b31-11f6-4c11-98e3-75916a1982d4 | 2024-04-04 | Warnings, Adverse reactions | 077955 ANDA077955 |
| Amlodipine besylate | AMLODIPINE BESYLATE | Bryant Ranch Prepack | f968393f-47d2-4c16-b34f-93a9d61adb9e | 2024-04-04 | Warnings, Adverse reactions | 077955 ANDA077955 |
| Amlodipine besylate | AMLODIPINE BESYLATE | Bryant Ranch Prepack | 498a9b21-34b9-4373-930b-5ed43201a345 | 2024-01-09 | Warnings, Adverse reactions | 077955 ANDA077955 |
| Amlodipine besylate | AMLODIPINE BESYLATE | Bryant Ranch Prepack | e8958997-f098-44ce-8c21-b7064d1a962e | 2024-01-09 | Warnings, Adverse reactions | 077955 ANDA077955 |
| Amlodipine besylate | AMLODIPINE BESYLATE | Aphena Pharma Solutions - Tennessee, LLC | 5dfcba1f-91c4-4ca5-8a98-fc4fdb2f7ee1 | 2023-09-07 | Warnings, Adverse reactions | 077955 ANDA077955 |
| Amlodipine besylate | AMLODIPINE BESYLATE | Exelan Pharmaceuticals, Inc. | efd9eda5-f497-45a3-ae13-dee729add999 | 2023-03-23 | Warnings, Adverse reactions | 077955 ANDA077955 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Cipla USA Inc. | 0c8d6b2f-3e4a-47a2-80e2-a34dcb337555 | 2020-09-09 | Warnings, Adverse reactions | 077955 ANDA077955 |
| Amlodipine besylate | AMLODIPINE BESYLATE | Aphena Pharma Solutions - Tennessee, LLC | 17e6d552-7528-4597-9498-104cb04f32e7 | 2017-10-25 | Warnings, Adverse reactions | 077955 ANDA077955 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308135 | amLODIPine besylate 10 MG Oral Tablet | PSN | 368408e8-87e0-4092-e054-00144ff88e88 | 1 |
| 308135 | amlodipine 10 MG Oral Tablet | SCD | 368408e8-87e0-4092-e054-00144ff88e88 | 1 |
| 308135 | amlodipine (as amlodipine besylate) 10 MG Oral Tablet | SY | 368408e8-87e0-4092-e054-00144ff88e88 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 12634-600-00 | 12634060000 | 10 in 1 BOTTLE | Historical |
| 12634-600-01 | 12634060001 | 100 in 1 BOTTLE | Historical |
| 12634-600-09 | 12634060009 | 35 in 1 BOTTLE | Historical |
| 12634-600-40 | 12634060040 | 40 in 1 BOTTLE | Historical |
| 12634-600-42 | 12634060042 | 42 in 1 BOTTLE | Historical |
| 12634-600-45 | 12634060045 | 45 in 1 BOTTLE | Historical |
| 12634-600-50 | 12634060050 | 50 in 1 BOTTLE | Historical |
| 12634-600-52 | 12634060052 | 12 in 1 BLISTER PACK | Historical |
| 12634-600-54 | 12634060054 | 14 in 1 BLISTER PACK | Historical |
| 12634-600-57 | 12634060057 | 20 in 1 BLISTER PACK | Historical |
| 12634-600-58 | 12634060058 | 28 in 1 BLISTER PACK | Historical |
| 12634-600-59 | 12634060059 | 30 in 1 BLISTER PACK | Historical |
| 12634-600-60 | 12634060060 | 60 in 1 BOTTLE | Historical |
| 12634-600-61 | 12634060061 | 10 in 1 BLISTER PACK | Historical |
| 12634-600-63 | 12634060063 | 3 in 1 BLISTER PACK | Historical |
| 12634-600-66 | 12634060066 | 6 in 1 BLISTER PACK | Historical |
| 12634-600-67 | 12634060067 | 7 in 1 BLISTER PACK | Historical |
| 12634-600-69 | 12634060069 | 9 in 1 BLISTER PACK | Historical |
| 12634-600-71 | 12634060071 | 30 in 1 BOTTLE | Historical |
| 12634-600-74 | 12634060074 | 24 in 1 BOTTLE | Historical |
| 12634-600-78 | 12634060078 | 28 in 1 BOTTLE | Historical |
| 12634-600-79 | 12634060079 | 25 in 1 BOTTLE | Historical |
| 12634-600-80 | 12634060080 | 20 in 1 BOTTLE | Historical |
| 12634-600-81 | 12634060081 | 21 in 1 BOTTLE | Historical |
| 12634-600-82 | 12634060082 | 12 in 1 BOTTLE | Historical |
| 12634-600-84 | 12634060084 | 14 in 1 BOTTLE | Historical |
| 12634-600-85 | 12634060085 | 15 in 1 BOTTLE | Historical |
| 12634-600-90 | 12634060090 | 90 in 1 BOTTLE | Historical |
| 12634-600-91 | 12634060091 | 1 in 1 BLISTER PACK | Historical |
| 12634-600-92 | 12634060092 | 2 in 1 BOTTLE | Historical |
| 12634-600-93 | 12634060093 | 3 in 1 BOTTLE | Historical |
| 12634-600-94 | 12634060094 | 4 in 1 BOTTLE | Historical |
| 12634-600-95 | 12634060095 | 5 in 1 BOTTLE | Historical |
| 12634-600-96 | 12634060096 | 6 in 1 BOTTLE | Historical |
| 12634-600-97 | 12634060097 | 7 in 1 BOTTLE | Historical |
| 12634-600-98 | 12634060098 | 8 in 1 BOTTLE | Historical |
| 12634-600-99 | 12634060099 | 9 in 1 BOTTLE | Historical |