Metformin Hydrochloride
- Product NDC
- 68788-7205
- 11-digit product format
- 687887205
- Labeler code
- 68788
- Product ID
- 68788-7205_7fdbbafe-2aae-433f-b400-9fec627aec43
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA078321
- Marketing category
- ANDA
- Marketing start
- 2018-07-23
- Marketing end
- 2026-09-30
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 750 mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Metformin Hydrochloride
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 750 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 860981 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-7205-1 | Metformin Hydrochloride | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 9 |
| 68788-7205-3 | Metformin Hydrochloride | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 9 |
| 68788-7205-6 | Metformin Hydrochloride | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 9 |
| 68788-7205-8 | Metformin Hydrochloride | 120 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 120 | | 9 |
| 68788-7205-9 | Metformin Hydrochloride | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-7205 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.] | 8 | Current NDC, Legacy NDC, 5 package rows | 20240522_bf918d78-3fb6-4d8d-b42d-538ea10bc3e4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-7205-1 | 68788720501 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7205-1) | 2018-07-23 | 2026-09-30 | No | No | Current |
| 68788-7205-3 | 68788720503 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7205-3) | 2018-07-23 | 2026-09-30 | No | No | Current |
| 68788-7205-6 | 68788720506 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7205-6) | 2018-07-23 | 2026-09-30 | No | No | Current |
| 68788-7205-8 | 68788720508 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7205-8) | 2018-07-23 | 2026-09-30 | No | No | Current |
| 68788-7205-9 | 68788720509 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7205-9) | 2018-07-23 | 2026-09-30 | No | No | Current |