Metformin Hydrochloride
- Product NDC
- 62207-441
- 11-digit product format
- 622070441
- Labeler code
- 62207
- Product ID
- 62207-441_4f9109a5-219e-40ed-e063-6394a90afa4f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride Tablet
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Granules India Ltd
- Application
- ANDA090564
- Marketing category
- ANDA
- Marketing start
- 2019-07-04
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 850 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 | 850 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 |
|---|
| 62207-441-43 | Metformin Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 12 |
| 62207-441-47 | Metformin Hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | | 12 |
| 62207-441-49 | Metformin Hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | | 12 |
| 62207-441-50 | Metformin Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 12 |
| 62207-441-57 | Metformin Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 12 |
| 62207-441-97 | Metformin Hydrochloride | 32857 in 1 DRUM | TABLET | 32857 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62207-441 | METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE TABLET) TABLET METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE TABLET) TABLET [GRANULES INDIA LTD] | 10 | Current NDC, Legacy NDC, 6 package rows | 20230209_8cd5555c-f6b2-28d8-e053-2a95a90a5f1e.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 |
|---|
| 62207-441-43 | 62207044143 | 100 TABLET in 1 BOTTLE (62207-441-43) | 100 tablet | 2019-07-04 | 0000-00-00 | No | No | Current |
| 62207-441-47 | 62207044147 | 500 TABLET in 1 BOTTLE (62207-441-47) | 500 tablet | 2019-07-04 | 0000-00-00 | No | No | Current |
| 62207-441-49 | 62207044149 | 1000 TABLET in 1 BOTTLE (62207-441-49) | 1000 tablet | 2019-07-04 | 0000-00-00 | No | No | Current |
| 62207-441-50 | 62207044150 | 60 TABLET in 1 BOTTLE (62207-441-50) | 60 tablet | 2019-07-04 | 0000-00-00 | No | No | Current |
| 62207-441-57 | 62207044157 | 90 TABLET in 1 BOTTLE (62207-441-57) | 90 tablet | 2019-07-04 | 0000-00-00 | No | No | Current |
| 62207-441-97 | 62207044197 | 32857 TABLET in 1 DRUM (62207-441-97) | 32857 tablet | 2019-07-04 | 0000-00-00 | No | No | Current |