METFORMIN HYDROCHLORIDE EXTENDED RELEASE
- Product NDC
- 49483-624
- 11-digit product format
- 494830624
- Labeler code
- 49483
- Product ID
- 49483-624_4d845f5a-3ab1-b5ac-e063-6394a90a75d6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- TIME CAP LABORATORIES, INC
- Application
- ANDA090295
- Marketing category
- ANDA
- Marketing start
- 2016-05-12
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 750 mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- METFORMIN HYDROCHLORIDE EXTENDED RELEASE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 750 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 860975, 860981 |
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 |
|---|
| 49483-624-01 | METFORMIN HYDROCHLORIDE EXTENDED RELEASE | 100 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 100 | | 10 |
| 49483-624-50 | METFORMIN HYDROCHLORIDE EXTENDED RELEASE | 500 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 500 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49483-624 | METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [TIME CAP LABORATORIES, INC] | 9 | Current NDC, Legacy NDC, 2 package rows | 20250212_1d8b8970-c2a1-4780-be87-ab8ccfd401fa.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 |
|---|
| 49483-624-01 | 49483062401 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49483-624-01) | 2016-05-12 | 0000-00-00 | No | No | Current |
| 49483-624-50 | 49483062450 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49483-624-50) | 2016-05-12 | 0000-00-00 | No | No | Current |