Metformin Hydrochloride
- Product NDC
- 65862-010
- Requested package NDC
- 65862-010-33
- 11-digit product format
- 658620010
- Labeler code
- 65862
- Product ID
- 65862-010_1c59d7bc-6118-4707-80c0-886ac00bab09
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA077095
- Marketing category
- ANDA
- Marketing start
- 2005-01-14
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 1000 mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A077095-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2005-01-14 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A077095-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2005-01-14 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A077095-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2005-01-14 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A077095-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A077095-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A077095-003 | AB | 1 | a50c72e98297… |
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 65862-010-33 65862-010 65862001033 |
| 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 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Metformin Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| METFORMIN HYDROCHLORIDE | 1000 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 786Z46389E | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4ac6d01a-af26-44e7-ae2e-3618de0080aa | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65862-010-01 | Metformin Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 16 | |
| 65862-010-05 | Metformin Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 16 | |
| 65862-010-33 | Metformin Hydrochloride | 300 in 1 BOTTLE | TABLET, FILM COATED | 300 | 16 | |
| 65862-010-46 | Metformin Hydrochloride | 2000 in 1 BOTTLE | TABLET, FILM COATED | 2000 | 16 | |
| 65862-010-50 | Metformin Hydrochloride | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | 16 | |
| 65862-010-60 | Metformin Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 16 | |
| 65862-010-90 | Metformin Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 16 | |
| 65862-010-99 | Metformin Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 16 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65862-010-01 | EA - Each | 65862-010 | cf153373-d77b-45e8-b5b0-9c1ad2428d72 | 1 | 2012-07-24 |
| 65862-010-05 | EA - Each | 65862-010 | c5f1fe48-2a3d-4ea3-a9ed-bbd558974f7c | 1 | 2012-07-24 |
| 65862-010-22 | EA - Each | 65862-010 | d167044d-81f1-4a16-a991-9de0e2f826a6 | 1 | 2024-06-10 |
| 65862-010-46 | EA - Each | 65862-010 | 7147d821-6c0f-4101-bc02-27fab470ec4c | 1 | 2012-07-24 |
| 65862-010-90 | EA - Each | 65862-010 | 51425598-1fa4-4421-bad2-a8d0b34622cb | 1 | 2012-07-24 |
| 65862-010-99 | EA - Each | 65862-010 | 0e50e7e5-743d-4c59-b494-275e9fc5cc68 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 65862-010-33 | 65862001033 | 300 TABLET, FILM COATED in 1 BOTTLE (65862-010-33) | 2005-01-14 | 0000-00-00 | No | No | Current |