Metformin hydrochloride
- Product NDC
- 53002-1445
- 11-digit product format
- 530021445
- Labeler code
- 53002
- Product ID
- 53002-1445_4ca8741f-24a7-4e31-94da-027adb8f9708
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA090564
- Marketing category
- ANDA
- Marketing start
- 2010-04-22
- Marketing end
- 0000-00-00
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 1000 mg/1
- Pharmacologic classes
- Biguanide [EPC],Biguanides [CS]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 53002-1445-0 | Metformin hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
| 53002-1445-0 | Metformin hydrochloride | 1 in 1 CONTAINER | TABLET | 1 | | 5 |
| 53002-1445-3 | Metformin hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 53002-1445-3 | Metformin hydrochloride | 1 in 1 CONTAINER | TABLET | 1 | | 5 |
| 53002-1445-6 | Metformin hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 5 |
| 53002-1445-6 | Metformin hydrochloride | 1 in 1 CONTAINER | TABLET | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-1445 | METFORMIN HYDROCHLORIDE TABLET [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 6 package rows | 20171231_69517af8-ac74-48e6-add7-1ef22661a8f6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53002-1445-0 | 53002144500 | 100 in 1 BOTTLE | Historical |
| 53002-1445-3 | 53002144503 | 30 in 1 BOTTLE | Historical |
| 53002-1445-6 | 53002144506 | 60 in 1 BOTTLE | Historical |