Metformin Hydrochloride
- Product NDC
- 43353-114
- Requested package NDC
- 43353-114-80
- 11-digit product format
- 433530114
- Labeler code
- 43353
- Product ID
- 43353-114_54921df4-d3d6-4ab2-aaf9-9789679c9f99
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA077095
- Marketing category
- ANDA
- Marketing start
- 2005-01-14
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 43353-114 | 43353-114-80 | D | Discontinued by firm | 2026-08-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077095-001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2005-01-14 | |
| A077095-002 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2005-01-14 | |
| A077095-003 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2005-01-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077095-001 | AB |
| A077095-002 | AB |
| A077095-003 | 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 | A077095-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2005-01-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077095-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2005-01-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077095-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2005-01-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077095-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2005-01-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077095-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2005-01-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077095-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2005-01-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077095-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2005-01-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077095-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2005-01-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077095-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2005-01-14 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077095-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2005-01-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077095-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2005-01-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077095-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2005-01-14 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077095-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2005-01-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077095-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2005-01-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077095-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2005-01-14 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077095-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2005-01-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077095-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2005-01-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077095-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2005-01-14 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077095-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2005-01-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077095-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2005-01-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077095-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2005-01-14 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077095-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2005-01-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077095-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2005-01-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077095-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2005-01-14 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077095-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2005-01-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077095-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2005-01-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077095-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2005-01-14 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077095-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2005-01-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077095-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2005-01-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077095-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2005-01-14 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077095-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2005-01-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077095-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2005-01-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077095-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2005-01-14 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077095-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2005-01-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077095-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2005-01-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077095-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2005-01-14 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077095-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2005-01-14 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077095-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2005-01-14 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077095-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2005-01-14 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077095-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2005-01-14 | 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 | A077095-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077095-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077095-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077095-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077095-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077095-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077095-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077095-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077095-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077095-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077095-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077095-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077095-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077095-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077095-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077095-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077095-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077095-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077095-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077095-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077095-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077095-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077095-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077095-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077095-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077095-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077095-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077095-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077095-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077095-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077095-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077095-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077095-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077095-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077095-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077095-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077095-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077095-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077095-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077095-001 | AB | 1 | 8072bd15b7f6… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Aurobindo Pharma Limited | 4ac6d01a-af26-44e7-ae2e-3618de0080aa | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | 077095 ANDA077095 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Aurobindo Pharma Limited | fc466c46-abaa-4675-aef2-4b1a1adfd912 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | 077095 ANDA077095 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 5d8d654a-9bb4-4c87-ab43-c21c4e874708 | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | 077095 ANDA077095 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | fb296500-55cb-45ce-be0c-59aa2e3d4624 | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | 077095 ANDA077095 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 073cf6d9-7142-4d8b-898e-174c62a1f76f | 2026-05-19 | Boxed warning, Warnings, Adverse reactions | 077095 ANDA077095 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 0448c618-2f0d-4ed3-866f-74b413cf902d | 2026-04-16 | Boxed warning, Warnings, Adverse reactions | 077095 ANDA077095 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 1d7556eb-82b4-4085-b0b1-dc061b216feb | 2026-02-02 | Boxed warning, Warnings, Adverse reactions | 077095 ANDA077095 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Northwind Health Company, LLC | db113f46-6fac-9005-e053-2995a90a017a | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 077095 ANDA077095 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 3d450933-8d9d-27de-e063-6294a90ae6d9 | 2025-08-26 | Boxed warning, Warnings, Adverse reactions | 077095 ANDA077095 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 3ab4efb6-bd30-2583-e063-6294a90a415b | 2025-07-24 | Boxed warning, Warnings, Adverse reactions | 077095 ANDA077095 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 23aa50c5-28fe-4322-b5c6-1f1c48409b16 | 2025-07-18 | Boxed warning, Warnings, Adverse reactions | 077095 ANDA077095 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 390c3bdf-bfaf-203e-e063-6394a90a7d20 | 2025-07-03 | Boxed warning, Warnings, Adverse reactions | 077095 ANDA077095 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 23aa0072-365c-4d13-9aa7-ae23f7e00ee4 | 2024-09-18 | Boxed warning, Warnings, Adverse reactions | 077095 ANDA077095 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 1a7f7ef3-a94b-4ff6-a9f2-f5de4a99c7f6 | 2024-04-28 | Boxed warning, Warnings, Adverse reactions | 077095 ANDA077095 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | afb183f6-a13c-4f00-82d5-9fe336173d34 | 2024-04-28 | Boxed warning, Warnings, Adverse reactions | 077095 ANDA077095 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Proficient Rx LP | 1b9b6db9-1bac-4252-a03c-18dc0271f05f | 2023-06-01 | Boxed warning, Warnings, Adverse reactions | 077095 ANDA077095 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43353-114-80 | EA - Each | 43353-114 | 3d15abe8-2fc3-4756-ae1c-3b41aab0008c | 1 | 2016-07-19 |
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 43353-114-80 | 43353011480 | 180 TABLET, FILM COATED in 1 BOTTLE (43353-114-80) | 2015-11-04 | 0000-00-00 | No | No | Current |