Metformin HCl
- Product NDC
- 82868-049
- 11-digit product format
- 828680049
- Labeler code
- 82868
- Product ID
- 82868-049_46dcc055-d88e-a2c8-e063-6294a90a2ed4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin HCl
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA090564
- Marketing category
- ANDA
- Marketing start
- 2024-02-21
- 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 HCl
- 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 |
|---|
| 82868-049-90 | Metformin HCl | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 2 |
| 82868-049-98 | Metformin HCl | 120 in 1 BOTTLE, PLASTIC | TABLET | 120 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82868-049 | METFORMIN HCL TABLET [NORTHWIND PHARMACEUTICALS, LLC] | 1 | Current NDC, 2 package rows | 20240627_13b1e35f-d047-8ddc-e063-6394a90a24dd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82868-049-90 | 82868004990 | 90 TABLET in 1 BOTTLE, PLASTIC (82868-049-90) | 90 tablet | 2024-03-25 | No | No | Historical |
| 82868-049-98 | 82868004998 | 120 TABLET in 1 BOTTLE, PLASTIC (82868-049-98) | 120 tablet | 2024-02-21 | No | No | Historical |