Metformin Hydrochloride
- Product NDC
- 42385-904
- 11-digit product format
- 423850904
- Labeler code
- 42385
- Product ID
- 42385-904_2c0747fd-dbaa-4e08-bbcf-317f14eda820
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Laurus Labs Limited
- Application
- ANDA209882
- Marketing category
- ANDA
- Marketing start
- 2019-01-15
- Marketing end
- 0000-00-00
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Biguanide [EPC],Biguanides [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 | 42385-904 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 42385-904 | 42385-904-01 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 42385-904 | 42385-904-05 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 42385-904 | 42385-904-09 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 42385-904 | 42385-904-10 | D | Discontinued by firm | 2026-08-03 |
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 | 42385-904-09 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 42385-904-10 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 42385-904-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 42385-904-01 | 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 | 42385-904-09 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 42385-904-10 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 42385-904-05 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 42385-904-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 42385-904-09 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 42385-904-10 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 42385-904-05 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 42385-904-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 42385-904-09 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 42385-904-10 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 42385-904-05 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 42385-904-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 42385-904-09 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 42385-904-10 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 42385-904-05 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 42385-904-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 42385-904-09 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 42385-904-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 42385-904-05 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 42385-904-01 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 42385-904-09 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 42385-904-10 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 42385-904-05 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 42385-904-01 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 42385-904-09 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 42385-904-10 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 42385-904-05 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 42385-904-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 42385-904-09 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 42385-904-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 42385-904-05 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 42385-904-01 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 42385-904-09 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 42385-904-10 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 42385-904-05 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 42385-904-01 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 42385-904-09 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 42385-904-10 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 42385-904-05 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 42385-904-01 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 42385-904-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 42385-904-10 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 42385-904-05 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 42385-904-01 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209882-001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2018-08-27 | |
| A209882-002 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2018-08-27 | |
| A209882-003 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2018-08-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209882-001 | AB |
| A209882-002 | AB |
| A209882-003 | 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 | A209882-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2018-08-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209882-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2018-08-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209882-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2018-08-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209882-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2018-08-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209882-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2018-08-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209882-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2018-08-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209882-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2018-08-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209882-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2018-08-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209882-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2018-08-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209882-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2018-08-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209882-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2018-08-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209882-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2018-08-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209882-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2018-08-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209882-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2018-08-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209882-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2018-08-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209882-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2018-08-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209882-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2018-08-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209882-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2018-08-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209882-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2018-08-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209882-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2018-08-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209882-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2018-08-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209882-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2018-08-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209882-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2018-08-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209882-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2018-08-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209882-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2018-08-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209882-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2018-08-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209882-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2018-08-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209882-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2018-08-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209882-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2018-08-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209882-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2018-08-27 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209882-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2018-08-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209882-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2018-08-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209882-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2018-08-27 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209882-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2018-08-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209882-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2018-08-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209882-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2018-08-27 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209882-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2018-08-27 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209882-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2018-08-27 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209882-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2018-08-27 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A209882-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2018-08-27 | 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 | A209882-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209882-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209882-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209882-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209882-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209882-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A209882-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209882-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209882-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209882-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209882-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209882-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209882-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209882-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209882-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209882-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209882-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209882-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209882-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209882-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209882-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209882-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209882-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209882-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209882-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209882-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209882-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A209882-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A209882-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A209882-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209882-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209882-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209882-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209882-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209882-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209882-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209882-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209882-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209882-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A209882-001 | AB | 1 | 8072bd15b7f6… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42385-904-10 | EA - Each | 42385-904 | ee992fa4-8777-49e7-a538-1454a6c54319 | 1 | 2019-03-12 |
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 |
|---|---|---|---|---|---|---|
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | f4fc759a-057e-4b5d-b8ab-13bc5eeb24e4 | 2026-06-12 | Boxed warning, Warnings, Adverse reactions | 209882 ANDA209882 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 400ff9dc-9789-44ac-afb5-730b632a1667 | 2026-06-12 | Boxed warning, Warnings, Adverse reactions | 209882 ANDA209882 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Laurus Labs Limited | c3dfa8a1-d10a-4a1a-8eba-5f4e2a5a2949 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | 209882 ANDA209882 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | be023bca-511e-4801-bd2b-e30dd1408772 | 2026-05-07 | Boxed warning, Warnings, Adverse reactions | 209882 ANDA209882 |
| Metformin HCL | METFORMIN HCL | Direct_Rx | 498ac5fc-14be-d36a-e063-6394a90a3012 | 2026-03-13 | Boxed warning, Warnings, Adverse reactions | 209882 ANDA209882 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 8c248958-6c01-455e-89f5-959facb272ed | 2026-01-29 | Boxed warning, Warnings, Adverse reactions | 209882 ANDA209882 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | f59ceea4-a84a-4082-8e73-7c6f340c28d6 | 2026-01-28 | Boxed warning, Warnings, Adverse reactions | 209882 ANDA209882 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 192970d3-826a-4b69-a525-9742794dc19c | 2026-01-28 | Boxed warning, Warnings, Adverse reactions | 209882 ANDA209882 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ca71c133-6c38-4b9e-80af-1949634157f4 | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | 209882 ANDA209882 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Northwind Health Company, LLC | 0178b9dd-bafa-9e81-e063-6294a90a88b0 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 209882 ANDA209882 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | bfd6ec0f-8264-4877-aa6d-f347f53bc426 | 2025-09-30 | Boxed warning, Warnings, Adverse reactions | 209882 ANDA209882 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Coupler LLC | 3eeee3b7-188a-05a0-e063-6294a90a1853 | 2025-09-16 | Boxed warning, Warnings, Adverse reactions | 209882 ANDA209882 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | e1ebb146-acfd-4301-a79c-f5bb243f8575 | 2025-08-06 | Boxed warning, Warnings, Adverse reactions | 209882 ANDA209882 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 33155746-c2ef-12f4-e063-6294a90a039c | 2025-04-18 | Boxed warning, Warnings, Adverse reactions | 209882 ANDA209882 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 0f251f2c-97f3-4048-84f2-81fea03685aa | 2025-01-15 | Boxed warning, Warnings, Adverse reactions | 209882 ANDA209882 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | 286d959a-51cb-4dbd-a3e8-1ea2f00b54c7 | 2024-12-10 | Boxed warning, Warnings, Adverse reactions | 209882 ANDA209882 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | ed6e6f87-ddd7-4c9d-a263-47154d3a9478 | 2024-08-27 | Boxed warning, Warnings, Adverse reactions | 209882 ANDA209882 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | c2783b59-7b20-4d4c-a3ca-03ed60dcf2c3 | 2024-03-10 | Boxed warning, Warnings, Adverse reactions | 209882 ANDA209882 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 2be73d5e-7682-4ad3-831b-8c1ea73e38de | 2024-03-10 | Boxed warning, Warnings, Adverse reactions | 209882 ANDA209882 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 42385-904-01 | 42385090401 | 100 TABLET, FILM COATED in 1 BOTTLE (42385-904-01) | 2019-01-15 | 0000-00-00 | No | No | Current |
| 42385-904-05 | 42385090405 | 500 TABLET, FILM COATED in 1 BOTTLE (42385-904-05) | 2019-01-15 | 0000-00-00 | No | No | Current |
| 42385-904-09 | 42385090409 | 90 TABLET, FILM COATED in 1 BOTTLE (42385-904-09) | 2019-01-15 | 0000-00-00 | No | No | Current |
| 42385-904-10 | 42385090410 | 1000 TABLET, FILM COATED in 1 BOTTLE (42385-904-10) | 2019-01-15 | 0000-00-00 | No | No | Current |