Metformin Hydrochloride
- Product NDC
- 66689-318
- 11-digit product format
- 666890318
- Labeler code
- 66689
- Product ID
- 66689-318_88a5077b-b1b5-47bb-ab45-32de55907ea6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- VistaPharm, LLC
- Application
- ANDA212677
- Marketing category
- ANDA
- Marketing start
- 2022-12-19
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 500 mg/5mL
- 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/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 861025 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66689-318-16 | Metformin Hydrochloride | 1 in 1 CARTON | SOLUTION | 1 | | 8 |
| 66689-318-16 | Metformin Hydrochloride | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66689-318 | METFORMIN HYDROCHLORIDE SOLUTION [VISTAPHARM, LLC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20241013_e087ce3b-8d7f-43a3-8d20-54513da7617d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 66689-318-16 | 66689031816 | 1 BOTTLE in 1 CARTON (66689-318-16) / 473 mL in 1 BOTTLE | 1 bottle | 2022-12-19 | 0000-00-00 | No | No | Current |