Metformin Hydrochloride
- Product NDC
- 59651-854
- 11-digit product format
- 596510854
- Labeler code
- 59651
- Product ID
- 59651-854_0bfb57c0-6114-4734-a8d7-b78102e7f8eb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA077095
- Marketing category
- ANDA
- Marketing start
- 2024-03-29
- 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 | 861004, 861007, 861010 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-854-01 | Metformin Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 3 |
| 59651-854-05 | Metformin Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 3 |
| 59651-854-45 | Metformin Hydrochloride | 4500 in 1 BOTTLE | TABLET, FILM COATED | 4500 | | 3 |
| 59651-854-50 | Metformin Hydrochloride | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | | 3 |
| 59651-854-60 | Metformin Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 3 |
| 59651-854-79 | Metformin Hydrochloride | 300 in 1 BOTTLE | TABLET, FILM COATED | 300 | | 3 |
| 59651-854-90 | Metformin Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
| 59651-854-99 | Metformin Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-854 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | Current NDC, 8 package rows | 20241225_fc466c46-abaa-4675-aef2-4b1a1adfd912.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-854-01 | 59651085401 | 100 TABLET, FILM COATED in 1 BOTTLE (59651-854-01) | 2024-03-29 | No | No | Historical |
| 59651-854-05 | 59651085405 | 500 TABLET, FILM COATED in 1 BOTTLE (59651-854-05) | 2024-03-29 | No | No | Historical |
| 59651-854-45 | 59651085445 | 4500 TABLET, FILM COATED in 1 BOTTLE (59651-854-45) | 2024-03-29 | No | No | Historical |
| 59651-854-50 | 59651085450 | 50 TABLET, FILM COATED in 1 BOTTLE (59651-854-50) | 2024-03-29 | No | No | Historical |
| 59651-854-60 | 59651085460 | 60 TABLET, FILM COATED in 1 BOTTLE (59651-854-60) | 2024-03-29 | No | No | Historical |
| 59651-854-79 | 59651085479 | 300 TABLET, FILM COATED in 1 BOTTLE (59651-854-79) | 2024-03-29 | No | No | Historical |
| 59651-854-90 | 59651085490 | 90 TABLET, FILM COATED in 1 BOTTLE (59651-854-90) | 2024-03-29 | No | No | Historical |
| 59651-854-99 | 59651085499 | 1000 TABLET, FILM COATED in 1 BOTTLE (59651-854-99) | 2024-03-29 | No | No | Historical |