Metformin Hydrochloride
- Product NDC
- 68094-688
- 11-digit product format
- 680940688
- Labeler code
- 68094
- Product ID
- 68094-688_ef55270e-91c5-46cf-89a5-afec4872afa4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Precision Dose, Inc.
- Application
- ANDA205096
- Marketing category
- ANDA
- Marketing start
- 2024-02-15
- 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 | 861004, 861007, 861010 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68094-688-60 | Metformin Hydrochloride | 500 in 1 BOTTLE | TABLET, COATED | 500 | | 2 |
| 68094-688-70 | Metformin Hydrochloride | 1000 in 1 BOTTLE | TABLET, COATED | 1000 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68094-688 | METFORMIN HYDROCHLORIDE TABLET, COATED [PRECISION DOSE, INC.] | 1 | Current NDC, 2 package rows | 20240215_37ff1b8e-a434-41c0-82e1-4583842921a5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68094-688-60 | 68094068860 | 500 TABLET, COATED in 1 BOTTLE (68094-688-60) | 2024-02-15 | No | No | Current |
| 68094-688-70 | 68094068870 | 1000 TABLET, COATED in 1 BOTTLE (68094-688-70) | 2024-02-15 | No | No | Current |