Metformin Hydrochloride
- Product NDC
- 68788-8498
- 11-digit product format
- 687888498
- Labeler code
- 68788
- Product ID
- 68788-8498_bc2f564b-191f-4096-8513-40e22986899d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA209882
- Marketing category
- ANDA
- Marketing start
- 2023-08-01
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Metformin Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 861007 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8498-1 | Metformin Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 2 |
| 68788-8498-3 | Metformin Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 68788-8498-6 | Metformin Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
| 68788-8498-7 | Metformin Hydrochloride | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 2 |
| 68788-8498-8 | Metformin Hydrochloride | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 2 |
| 68788-8498-9 | Metformin Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8498 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] | 2 | Current NDC, 6 package rows | 20250117_0f251f2c-97f3-4048-84f2-81fea03685aa.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8498-1 | 68788849801 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-8498-1) | 2023-08-01 | No | No | Historical |
| 68788-8498-3 | 68788849803 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8498-3) | 2023-08-01 | No | No | Historical |
| 68788-8498-6 | 68788849806 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8498-6) | 2023-08-01 | No | No | Historical |
| 68788-8498-7 | 68788849807 | 180 TABLET, FILM COATED in 1 BOTTLE (68788-8498-7) | 2023-08-01 | No | No | Historical |
| 68788-8498-8 | 68788849808 | 120 TABLET, FILM COATED in 1 BOTTLE (68788-8498-8) | 2023-08-01 | No | No | Historical |
| 68788-8498-9 | 68788849809 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8498-9) | 2023-08-01 | No | No | Historical |