NDC 68788-8341-01 - Glyburide and 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
- 68788-8341
- Requested NDC
- 68788-8341-01
- Package NDCs from labels
- 68788-8341-3, 68788-8341-6, 68788-8341-9, 68788-8341-1, 68788-8341-8, 68788-8341-01
- Manufacturer
- Preferred Pharmaceuticals Inc.
- Effective date
- 2026-05-07
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Glyburide and Metformin Hydrochloride - Preferred Pharmaceuticals Inc. | Preferred Pharmaceuticals Inc. | 2026-05-07 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68788-8341-1 | Glyburide and Metformin Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 4 | |
| 68788-8341-3 | Glyburide and Metformin Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 4 | |
| 68788-8341-6 | Glyburide and Metformin Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 4 | |
| 68788-8341-8 | Glyburide and Metformin Hydrochloride | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | 4 | |
| 68788-8341-9 | Glyburide and Metformin Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68788-8341 | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] | 2 | Current NDC, 5 package rows | 20240517_c284c146-436b-4eea-9dca-d7d21c82778c.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-8341-1 | EA - Each | 68788-8341 | 6df5284e-ca0b-418a-93ca-5a1d140e7feb | 1 | 2023-03-13 |
| 68788-8341-3 | EA - Each | 68788-8341 | 1eb74ae8-616b-4c73-b7ac-c3198a4ed2ef | 1 | 2023-03-13 |
| 68788-8341-6 | EA - Each | 68788-8341 | dc3f0ebf-7a64-44ad-8507-ad3e70714344 | 1 | 2023-03-13 |
| 68788-8341-8 | EA - Each | 68788-8341 | 817cc0b7-b217-4cd2-83be-c1dd7440e9dd | 1 | 2023-03-13 |
| 68788-8341-9 | EA - Each | 68788-8341 | 13c692d5-7334-4840-a09f-1dd8d96a3138 | 1 | 2023-03-13 |
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 |
|---|---|---|---|---|---|---|
| Sitagliptin and Metformin Hydrochloride | SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | Golden State Medical Supply, Inc. | 58f0e875-5d9b-be0b-e063-6394a90a5345 | 2026-08-13 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Quallent Pharmaceuticals Health LLC | 25be863d-490c-47f6-9ad3-c828dc43fbf0 | 2026-08-12 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Sitagliptin and metformin hydrochloride | SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | 4d812277-21a8-4de3-b728-e3fdd01305b5 | 2026-08-12 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Sitagliptin and metformin hydrochloride | SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | Zydus Lifesciences Limited | e07abcb1-1f0c-4cad-8405-8eedba4b8ff8 | 2026-08-12 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| ZITUVIMET | SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | Zydus Lifesciences Limited | 0098dec4-f0e5-45d5-8aa4-5d0faf9ab142 | 2026-08-12 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| SEGLUROMET | ERTUGLIFLOZIN AND METFORMIN HYDROCHLORIDE | Merck Sharp & Dohme LLC | a6aeb99a-ce49-4125-90ce-642df3f1ebad | 2026-08-11 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| JANUMET XR | SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | Merck Sharp & Dohme LLC | 64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50 | 2026-08-11 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Redpharm Drug | 58bec665-b648-6baf-e063-6394a90a1cbb | 2026-08-11 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | e22a8545-86a6-439e-a758-29c4d6ed8bfe | 2026-08-11 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Stay Ageless Tinted Mineral Sunscreen | BROAD SPECTRUM SPF30 | DR. SAMRAO'S OFFICE | 58b2ca35-11ed-d848-e063-6294a90a5b37 | 2026-08-11 | Warnings | 15FIX9V2JP |
| JANUMET | SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | Merck Sharp & Dohme LLC | d19c7ed0-ad5c-426e-b2df-722508f97d67 | 2026-08-11 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Synjardy XR | EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE | Boehringer Ingelheim Pharmaceuticals, Inc. | 8006ba29-ee3a-f852-a9bb-c8ec9b41cf66 | 2026-08-11 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| XIGDUO XR | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | AstraZeneca Pharmaceuticals LP | ac8a0f7b-9f69-4495-abbc-3a47cd75a859 | 2026-08-11 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| SYSTANE HYDRATION PF PRESERVATIVE FREE | POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL | Alcon Laboratories, Inc. | 8936f66f-10fe-44ab-a26e-dd8b05dfa997 | 2026-08-10 | Warnings | 6DC9Q167V3 |
| Systane Pro PF | PROPYLENE GLYCOL | Alcon Laboratories, Inc. | 23b3515f-fbe5-4398-b2df-8b2eccdd01e2 | 2026-08-10 | Warnings | 6DC9Q167V3 |
| VEIRFOO Brightening Hydrating Antiwrinkle Sunscreen | TITANIUM DIOXIDE, OCTINOXATE | LCM TECHNOLOGY Co., Ltd | 4cbbf8aa-8910-b7e7-e063-6294a90a4f07 | 2026-08-07 | Warnings | 15FIX9V2JP |
| EltaMD UV Restore | TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc | 37fee381-ce6b-4949-9a4a-778aa839fb84 | 2026-08-06 | Warnings | 15FIX9V2JP |
| Leader Lubricant Eye Drops 30ct | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | CARDINAL HEALTH 110, LLC. DBA LEADER | 8df69f2c-40c4-245c-e053-2a95a90a5406 | 2026-08-05 | Warnings | 6DC9Q167V3 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | c1bfc7b5-c7e0-4353-b772-05d463c12886 | 2026-08-04 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 1e8136e0-cc98-41e4-ad4b-a8fc27fb4daa | 2026-08-04 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.