METFORMIN HYDROCHLORIDE
- Product NDC
- 66064-1042
- 11-digit product format
- 660641042
- Labeler code
- 66064
- Product ID
- 66064-1042_a600530d-9201-4ccc-b677-fc4ecdf7dba7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metformin hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Harman Finochem Limited
- Application
- ANDA213320
- Marketing category
- ANDA
- Marketing start
- 2022-06-01
- Marketing end
- 0000-00-00
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 1000 mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 | 66064-1042 | D | Discontinued by firm | 2026-08-07 | ||
| excluded package | package | 66064-1042 | 66064-1042-5 | D | Discontinued by firm | 2026-08-07 | |
| excluded package | package | 66064-1042 | 66064-1042-6 | D | Discontinued by firm | 2026-08-07 |
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 | 66064-1042-5 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 66064-1042-6 | 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 | 66064-1042-5 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 66064-1042-6 | 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 | 66064-1042-5 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 66064-1042-6 | 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 | 66064-1042-5 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 66064-1042-6 | 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 | 66064-1042-5 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 66064-1042-6 | 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 | 66064-1042-5 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 66064-1042-6 | 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 | 66064-1042-5 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 66064-1042-6 | 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 | 66064-1042-5 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 66064-1042-6 | 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 | 66064-1042-5 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 66064-1042-6 | 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 | 66064-1042-5 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 66064-1042-6 | 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 | 66064-1042-5 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 66064-1042-6 | 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 | 66064-1042-5 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 66064-1042-6 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213320-001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2021-12-03 | |
| A213320-002 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2021-12-03 | |
| A213320-003 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2021-12-03 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A213320-001 | AB |
| A213320-002 | AB |
| A213320-003 | 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 | A213320-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2021-12-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213320-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2021-12-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213320-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2021-12-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213320-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2021-12-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213320-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2021-12-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213320-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2021-12-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213320-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2021-12-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213320-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2021-12-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213320-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2021-12-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213320-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2021-12-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213320-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2021-12-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213320-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2021-12-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213320-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2021-12-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213320-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2021-12-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213320-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2021-12-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213320-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2021-12-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213320-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2021-12-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213320-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2021-12-03 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213320-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2021-12-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213320-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2021-12-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213320-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2021-12-03 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213320-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2021-12-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213320-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2021-12-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213320-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2021-12-03 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213320-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2021-12-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213320-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2021-12-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213320-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2021-12-03 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213320-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2021-12-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213320-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2021-12-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213320-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2021-12-03 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213320-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2021-12-03 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213320-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2021-12-03 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213320-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2021-12-03 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213320-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2021-12-03 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213320-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2021-12-03 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213320-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2021-12-03 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213320-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2021-12-03 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213320-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2021-12-03 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213320-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2021-12-03 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A213320-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2021-12-03 | 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 | A213320-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213320-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213320-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213320-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213320-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213320-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A213320-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213320-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213320-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213320-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213320-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213320-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213320-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213320-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213320-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213320-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213320-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213320-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213320-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213320-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213320-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213320-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213320-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213320-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213320-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213320-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213320-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A213320-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213320-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213320-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213320-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213320-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213320-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213320-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213320-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213320-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213320-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213320-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213320-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A213320-001 | AB | 1 | 8072bd15b7f6… |
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 | Preferred Pharmaceuticals Inc. | 4182bcf0-1f9a-4f3a-9428-86b5d757954f | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | 213320 ANDA213320 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 14450912-54b5-4fc3-ba65-77ece864b2e7 | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | 213320 ANDA213320 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | QPharma Inc | 53bde438-4277-f418-e063-6394a90a5ea2 | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | 213320 ANDA213320 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 4d087f00-580b-4b9d-80d9-f97930153e72 | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | 213320 ANDA213320 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | 1e7ab8da-4ece-499c-b0fb-34e37d991c1c | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | 213320 ANDA213320 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | abd0dad9-5f29-4102-a099-dce7bdddb98b | 2026-03-13 | Boxed warning, Warnings, Adverse reactions | 213320 ANDA213320 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 239834b0-121a-4903-b3ee-90bb4db4753b | 2026-02-04 | Boxed warning, Warnings, Adverse reactions | 213320 ANDA213320 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 5f2023d2-05ae-489d-9e18-fb75057496bc | 2026-02-04 | Boxed warning, Warnings, Adverse reactions | 213320 ANDA213320 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 5073c482-952c-400c-afff-64380f133bc8 | 2026-01-16 | Boxed warning, Warnings, Adverse reactions | 213320 ANDA213320 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | e3e9b582-fd15-4fe0-a210-398d9149696e | 2026-01-12 | Boxed warning, Warnings, Adverse reactions | 213320 ANDA213320 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | b63bfafa-db4c-4fb8-84cd-ff73a5e7d320 | 2025-12-17 | Boxed warning, Warnings, Adverse reactions | 213320 ANDA213320 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Ascend Laboratories, LLC | 8c7835fa-3f68-4850-b1da-34893bafb485 | 2025-08-28 | Boxed warning, Warnings, Adverse reactions | 213320 ANDA213320 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 3cbb802d-d493-255e-e063-6294a90a32f2 | 2025-08-19 | Boxed warning, Warnings, Adverse reactions | 213320 ANDA213320 |
| Metformin HCL | METFORMIN HCL | Direct_Rx | 2ffeb25a-76a9-01e6-e063-6394a90ae332 | 2025-07-25 | Boxed warning, Warnings, Adverse reactions | 213320 ANDA213320 |
| Metformin HCL | METFORMIN HCL | Direct_Rx | 3ac4e864-4b8a-13b1-e063-6294a90ada66 | 2025-07-25 | Boxed warning, Warnings, Adverse reactions | 213320 ANDA213320 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Coupler LLC | 2d7d9364-e71d-4ef6-e063-6394a90af841 | 2025-02-06 | Boxed warning, Warnings, Adverse reactions | 213320 ANDA213320 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 0865f83f-0f34-0690-e063-6294a90abf04 | 2025-02-03 | Boxed warning, Warnings, Adverse reactions | 213320 ANDA213320 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 0b3d5420-d60c-8385-e063-6394a90abb6c | 2025-02-03 | Boxed warning, Warnings, Adverse reactions | 213320 ANDA213320 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 289dc8ec-42c8-1d09-e063-6394a90a97f0 | 2024-12-06 | Boxed warning, Warnings, Adverse reactions | 213320 ANDA213320 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 0710e208-5b2c-3c72-e063-6394a90a4dac | 2024-09-26 | Boxed warning, Warnings, Adverse reactions | 213320 ANDA213320 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 66064-1042-5 | 66064104205 | 100 AEROSOL in 1 BOTTLE (66064-1042-5) | 100 aerosol | 2022-06-01 | 0000-00-00 | No | No | Current |
| 66064-1042-6 | 66064104206 | 500 AEROSOL in 1 BOTTLE (66064-1042-6) | 500 aerosol | 2022-06-01 | 0000-00-00 | No | No | Current |