AMLODIPINE BESYLATE
- Product NDC
- 61919-844
- Requested package NDC
- 61919-844-30
- 11-digit product format
- 619190844
- Labeler code
- 61919
- Product ID
- 61919-844_c936cb53-35a5-d89d-e053-2a95a90a2701
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMLODIPINE BESYLATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- DirectRX
- Application
- ANDA203245
- Marketing category
- ANDA
- Marketing start
- 2015-01-01
- 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
- 2022-12-31
- 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 package | package | 61919-844 | 61919-844-30 | I | Inactivated by FDA | 2026-08-11 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203245-001 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2013-10-21 | |
| A203245-002 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2013-10-21 | |
| A203245-003 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2013-10-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203245-001 | AB |
| A203245-002 | AB |
| A203245-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A203245-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203245-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203245-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2013-10-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203245-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203245-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203245-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2013-10-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203245-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203245-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203245-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2013-10-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203245-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2013-10-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203245-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2013-10-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203245-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2013-10-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203245-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2013-10-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203245-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2013-10-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203245-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2013-10-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203245-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203245-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203245-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2013-10-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203245-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203245-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203245-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2013-10-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203245-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203245-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203245-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2013-10-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203245-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2013-10-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203245-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2013-10-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203245-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2013-10-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203245-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2013-10-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203245-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2013-10-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203245-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2013-10-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203245-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203245-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203245-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2013-10-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203245-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203245-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203245-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2013-10-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203245-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203245-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203245-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2013-10-21 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A203245-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A203245-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203245-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203245-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203245-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203245-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203245-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203245-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203245-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203245-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203245-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203245-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203245-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203245-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203245-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203245-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203245-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203245-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203245-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203245-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203245-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203245-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203245-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203245-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203245-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203245-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203245-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203245-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A203245-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203245-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203245-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203245-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203245-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203245-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203245-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203245-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203245-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203245-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203245-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203245-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A203245-001 | AB | 1 | 8072bd15b7f6… |
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#
| NDC | Effective | Indexing SPL | Related label |
|---|---|---|---|
| 61919-844-30 | 2025-01-30 | 1030e365-0fa0-111a-e063-dadaa90a10e2 | AMLODIPINE BESYLATE |
| 61919-844-71 | 2025-01-30 | 1030e365-0fa0-111a-e063-dadaa90a10e2 | AMLODIPINE BESYLATE |
| 61919-844-90 | 2025-01-30 | 1030e365-0fa0-111a-e063-dadaa90a10e2 | AMLODIPINE BESYLATE |
| 61919-844-30 | 2024-01-30 | 1030e365-0fa0-111a-e063-dadaa90a10e2 | AMLODIPINE BESYLATE |
| 61919-844-60 | 2024-01-30 | 1030e365-6ed9-111a-e063-dadaa90a10e2 | AMLODIPINE BESYLATE |
| 61919-844-71 | 2024-01-30 | 1030e365-0fa0-111a-e063-dadaa90a10e2 | AMLODIPINE BESYLATE |
| 61919-844-90 | 2024-01-30 | 1030e365-0fa0-111a-e063-dadaa90a10e2 | AMLODIPINE BESYLATE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61919-844-30 | AMLODIPINE BESYLATE | 30 in 1 BOTTLE | TABLET | 30 | 5 | |
| 61919-844-71 | AMLODIPINE BESYLATE | 100 in 1 BOTTLE | TABLET | 100 | 5 | |
| 61919-844-90 | AMLODIPINE BESYLATE | 90 in 1 BOTTLE | TABLET | 90 | 5 | |
| 61919-844-60 | AMLODIPINE BESYLATE | 60 in 1 BOTTLE | TABLET | 60 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61919-844-30 | EA - Each | 61919-844 | ae87766d-70ee-41b3-ab67-b8134d1048ae | 1 | 2016-02-04 |
| 61919-844-60 | EA - Each | 61919-844 | b2cb9335-e0f6-4a91-af64-17801e8a519b | 1 | 2019-08-06 |
| 61919-844-71 | EA - Each | 61919-844 | d22cb3c7-6e77-4643-9578-cd19b9f1318b | 1 | 2017-03-06 |
| 61919-844-90 | EA - Each | 61919-844 | 9f0a3ed0-6e46-4ffc-8405-f9cbc1ff9727 | 1 | 2019-09-05 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| AMLODIPINE BESYLATE | ACTIVE INGREDIENT | 864V2Q084H | AMLODIPINE BESYLATE TABLET [DIRECTRX] | 1 | |
| AMLODIPINE | ACTIVE MOIETY | 1J444QC288 | AMLODIPINE BESYLATE TABLET [DIRECTRX] | 1 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | AMLODIPINE BESYLATE TABLET [DIRECTRX] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMLODIPINE BESYLATE TABLET [DIRECTRX] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMLODIPINE BESYLATE TABLET [DIRECTRX] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | AMLODIPINE BESYLATE TABLET [DIRECTRX] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61919-844 | AMLODIPINE BESYLATE TABLET AMLODIPINE BESYLATE TABLET [DIRECTRX] | 5 | Legacy NDC, 3 package rows | 20210811_b2ce9cd0-1c79-4b35-b87b-daff2c381a73.zip |
| 61919-844 | AMLODIPINE BESYLATE TABLET [DIRECT_RX] | 1 | Legacy NDC, 1 package rows | 20190730_8ed46bb1-9fc9-4418-e053-2a95a90abd4b.zip |
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 | ST. MARY'S MEDICAL PARK PHARMACY | b2d5cccd-e5ff-2909-e053-2a95a90a9773 | 2026-05-22 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | REMEDYREPACK INC. | 988e5acb-356e-4116-b6db-ab8468ed7234 | 2026-04-13 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Preferred Pharmaceuticals Inc. | 743ae641-14e1-456b-80e6-c6f7d621e969 | 2026-01-16 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Northwind Health Company, LLC | 0de6a6d0-a114-e114-e063-6394a90a34dd | 2025-12-26 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 41af64c4-b788-d827-e063-6394a90a9157 | 2025-10-21 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | REMEDYREPACK INC. | 3e0fbf93-cc64-4fa5-b586-c2020614c884 | 2025-09-03 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Direct_Rx | 0c7d1f99-dfe0-7041-e063-6294a90a9705 | 2025-07-11 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Redpharm Drug | fc61eee9-ee15-9078-e053-6394a90a22f4 | 2025-01-23 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Quality Care Products, LLC | a75e4797-6b7f-4366-9105-79d6877adac5 | 2024-12-19 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | A-S Medication Solutions | 699d3ba2-a342-4e3d-b8ad-c14e0df64dfe | 2024-10-09 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | A-S Medication Solutions | da4e36d3-1ddc-4350-9a00-86975e523f75 | 2024-10-09 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Bryant Ranch Prepack | b1151904-5085-49bd-94ec-cb2894f4eb10 | 2024-08-22 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | NuCare Pharmaceuticals,Inc. | b4cc6d7e-923b-e81c-e053-2995a90a0731 | 2024-07-17 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Direct_Rx | 094498f2-11d9-2a05-e063-6294a90ab2e1 | 2024-06-13 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | A-S Medication Solutions | 5a67bbdc-ac1f-4778-bbdc-929df140b7f5 | 2024-06-10 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Bryant Ranch Prepack | 52daa759-3327-461a-8cfc-3c6253df91ec | 2024-03-05 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | A-S Medication Solutions | 5c50c3fe-afe5-459e-95c0-c9af4cbb6909 | 2023-11-13 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Unichem Pharmaceuticals (USA), Inc. | a516b336-8f60-4b86-8921-c7d6c07629f2 | 2022-12-05 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Proficient Rx LP | 5f3ac64c-6e33-40c1-9b8e-dc0c8dd7e8d6 | 2022-04-01 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Proficient Rx LP | c2c51ec3-ffb0-4240-b048-a8e424775a76 | 2021-08-01 | Warnings, Adverse reactions | 203245 ANDA203245 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308135 | amLODIPine besylate 10 MG Oral Tablet | PSN | b2ce9cd0-1c79-4b35-b87b-daff2c381a73 | 5 |
| 197361 | amLODIPine besylate 5 MG Oral Tablet | PSN | b2ce9cd0-1c79-4b35-b87b-daff2c381a73 | 5 |
| 308135 | amlodipine 10 MG Oral Tablet | SCD | b2ce9cd0-1c79-4b35-b87b-daff2c381a73 | 5 |
| 197361 | amlodipine 5 MG Oral Tablet | SCD | b2ce9cd0-1c79-4b35-b87b-daff2c381a73 | 5 |
| 308135 | amlodipine (as amlodipine besylate) 10 MG Oral Tablet | SY | b2ce9cd0-1c79-4b35-b87b-daff2c381a73 | 5 |
| 197361 | amlodipine (as amlodipine besylate) 5 MG Oral Tablet | SY | b2ce9cd0-1c79-4b35-b87b-daff2c381a73 | 5 |
| 197361 | amLODIPine besylate 5 MG Oral Tablet | PSN | 8ed46bb1-9fc9-4418-e053-2a95a90abd4b | 1 |
| 197361 | amlodipine 5 MG Oral Tablet | SCD | 8ed46bb1-9fc9-4418-e053-2a95a90abd4b | 1 |
| 197361 | amlodipine (as amlodipine besylate) 5 MG Oral Tablet | SY | 8ed46bb1-9fc9-4418-e053-2a95a90abd4b | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61919-844-30 | 61919084430 | 30 TABLET in 1 BOTTLE (61919-844-30) | 30 tablet | 2015-01-01 | 0000-00-00 | No | No | Current |