NDC 69238-2126-01 - Metformin Hydrochloride
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 69238-2126
- Requested NDC
- 69238-2126-01
- Package NDCs from labels
- 69238-2126-3, 69238-2126-9, 69238-2126-1, 69238-2126-5, 69238-2126-01
- Manufacturer
- Amneal Pharmaceuticals LLC
- Effective date
- 2026-07-01
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Metformin Hydrochloride - Amneal Pharmaceuticals LLC | Amneal Pharmaceuticals LLC | 2026-07-01 | HUMAN PRESCRIPTION DRUG LABEL |
| Metformin Hydrochloride - AvKARE | AvKARE | 2026-05-13 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69238-2126-1 | Metformin Hydrochloride | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | 5 | |
| 69238-2126-3 | Metformin Hydrochloride | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | 5 | |
| 69238-2126-5 | Metformin Hydrochloride | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | 5 | |
| 69238-2126-9 | Metformin Hydrochloride | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69238-2126 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS NY LLC] | 4 | Current NDC, Legacy NDC, 4 package rows | 20231128_dc65065b-cba0-46d7-8fb5-3368f3210b4d.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 |
|---|---|---|---|---|---|---|
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Unichem Pharmaceuticals (USA), Inc. | 9eebed09-2562-4d21-b3b3-c06562fe3f99 | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | 860975 860981 786Z46389E |
| Glyburide and Metformin Hydrochloride | GLYBURIDE AND METFORMIN HYDROCHLORIDE | Aurobindo Pharma Limited | 7010b662-8b34-49ce-8e5b-73dee0821a60 | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | MARKSANS PHARMA LIMITED | d09a2eda-fdd8-44ed-8e2f-ea91ddfd3c68 | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | 860975 860981 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE TABLET | Granules India Ltd | 8cd5555c-f6b2-28d8-e053-2a95a90a5f1e | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Glipizide and Metformin Hydrochloride | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | Zydus Pharmaceuticals USA Inc. | 1b18b903-eb52-4d08-b4a5-f984957eb116 | 2026-06-27 | Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Unit Dose Solutions, Inc. | 552ad61d-bafd-478d-e063-6294a90a02f9 | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin HCl | METFORMIN HCL | Unit Dose Solutions, Inc. | 552df462-6dcb-e6f2-e063-6294a90aacfe | 2026-06-26 | Warnings, Adverse reactions | 786Z46389E |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Marlex Pharmaceuticals, Inc. | 3d6f397b-e909-bee9-e063-6294a90aba17 | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 860975 860981 786Z46389E |
| Glipizide and Metformin HCl | GLIPIZIDE AND METFORMIN HCL | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 94a7f96e-2ed1-432d-bc6a-5840863816e1 | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Viona Pharmaceuticals Inc | 85027e6c-d35b-49eb-a234-dd71aa77aee0 | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 860975 860981 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS | AiPing Pharmaceutical, Inc. | 96c8a89d-99db-24b1-e053-2a95a90ac2b8 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 41a8bb80-7b0b-476c-8134-5d161c3239c8 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Aurobindo Pharma Limited | 8d4b8620-5e99-4d12-b4f2-e9967b627b57 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | 860975 860981 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Major Pharmaceuticals | 5e783025-bf6d-465e-bf58-bcd253afad2c | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 4182bcf0-1f9a-4f3a-9428-86b5d757954f | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Rohto Sun and Sport | HYPROMELLOSE, POVIDONE | The Mentholatum Company | 8bcc8882-b886-4b55-9bc4-d4b92a41358f | 2026-06-19 | Warnings | FZ989GH94E |
| Rohto Dual Light Relief | HYPROMELLOSE, POVIDONE | The Mentholatum Company | 1b597f83-d7f1-cf93-e063-6394a90a99f7 | 2026-06-19 | Warnings | FZ989GH94E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 62ca8af4-ff91-4bf6-b7c6-895b3b5ce8c3 | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 14450912-54b5-4fc3-ba65-77ece864b2e7 | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 902d1bc4-3f1f-4a1a-86d7-cf98c56a3684 | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.