Metformin hydrochloride
- Product NDC
- 63187-779
- 11-digit product format
- 631870779
- Labeler code
- 63187
- Product ID
- 63187-779_103cbde3-9398-44e5-b27e-c4c77a46e97a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA201991
- Marketing category
- ANDA
- Marketing start
- 2013-03-01
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 500 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
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 860975 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-779-30 | Metformin hydrochloride | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 6 |
| 63187-779-60 | Metformin hydrochloride | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 6 |
| 63187-779-78 | Metformin hydrochloride | 180 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 180 | | 6 |
| 63187-779-90 | Metformin hydrochloride | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-779 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PROFICIENT RX LP] | 5 | Current NDC, Legacy NDC, 4 package rows | 20250501_3ba957ea-28ed-4a61-a318-98064ea4944d.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 |
|---|
| 63187-779-00 | 63187077900 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-779-00) | 2016-11-01 | 0000-00-00 | No | No | Current |
| 63187-779-20 | 63187077920 | 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-779-20) | 2016-11-01 | 0000-00-00 | No | No | Current |
| 63187-779-30 | 63187077930 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-779-30) | 2016-11-01 | 0000-00-00 | No | No | Current |
| 63187-779-60 | 63187077960 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-779-60) | 2025-04-23 | 0000-00-00 | No | No | Current |
| 63187-779-78 | 63187077978 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-779-78) | 2026-01-05 | | No | No | Current |
| 63187-779-90 | 63187077990 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-779-90) | 2016-11-01 | 0000-00-00 | No | No | Current |