Metformin Hydrochloride
- Product NDC
- 43063-544
- 11-digit product format
- 430630544
- Labeler code
- 43063
- Product ID
- 43063-544_413942f3-9d8b-ea87-e063-6394a90aeb7f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA077880
- Marketing category
- ANDA
- Marketing start
- 2012-12-17
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 1000 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 | 1000 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 861004 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43063-544-30 | Metformin Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 18 |
| 43063-544-60 | Metformin Hydrochloride | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 18 |
| 43063-544-90 | Metformin Hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 18 |
| 43063-544-93 | Metformin Hydrochloride | 180 in 1 BOTTLE, PLASTIC | TABLET | 180 | | 18 |
| 43063-544-98 | Metformin Hydrochloride | 120 in 1 BOTTLE, PLASTIC | TABLET | 120 | | 18 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-544 | METFORMIN HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] | 17 | Current NDC, Legacy NDC, 5 package rows | 20240508_c72cfd1a-dce9-43a3-88e2-3cf1d9078b52.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 |
|---|
| 43063-544-30 | 43063054430 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-544-30) | 30 tablet | 2014-04-03 | 0000-00-00 | No | No | Current |
| 43063-544-60 | 43063054460 | 60 TABLET in 1 BOTTLE, PLASTIC (43063-544-60) | 60 tablet | 2014-04-03 | 0000-00-00 | No | No | Current |
| 43063-544-90 | 43063054490 | 90 TABLET in 1 BOTTLE, PLASTIC (43063-544-90) | 90 tablet | 2014-04-03 | 0000-00-00 | No | No | Current |
| 43063-544-93 | 43063054493 | 180 TABLET in 1 BOTTLE, PLASTIC (43063-544-93) | 180 tablet | 2014-04-03 | 0000-00-00 | No | No | Current |
| 43063-544-98 | 43063054498 | 120 TABLET in 1 BOTTLE, PLASTIC (43063-544-98) | 120 tablet | 2014-04-03 | 0000-00-00 | No | No | Current |