Metformin Hydrochloride
- Product NDC
- 62135-684
- 11-digit product format
- 621350684
- Labeler code
- 62135
- Product ID
- 62135-684_52180966-60bd-3f94-e063-6394a90a0212
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA075972
- Marketing category
- ANDA
- Marketing start
- 2002-01-24
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 1000 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 | 1000 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 861004, 861007, 861010, 861021, 2703582 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-684-05 | Metformin Hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | | 4 |
| 62135-684-10 | Metformin Hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | | 4 |
| 62135-684-18 | Metformin Hydrochloride | 180 in 1 BOTTLE | TABLET | 180 | | 4 |
| 62135-684-60 | Metformin Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 4 |
| 62135-684-90 | Metformin Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-684 | METFORMIN HYDROCHLORIDE TABLET [CHARTWELL RX, LLC] | 3 | Current NDC, Legacy NDC, 5 package rows | 20231013_4d3dbf6f-1c8a-4daa-8343-8cd8f64a65cd.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 |
|---|
| 62135-684-05 | 62135068405 | 500 TABLET in 1 BOTTLE (62135-684-05) | 500 tablet | 2022-04-06 | 0000-00-00 | No | No | Current |
| 62135-684-10 | 62135068410 | 1000 TABLET in 1 BOTTLE (62135-684-10) | 1000 tablet | 2022-04-06 | 0000-00-00 | No | No | Current |
| 62135-684-18 | 62135068418 | 180 TABLET in 1 BOTTLE (62135-684-18) | 180 tablet | 2022-04-06 | 0000-00-00 | No | No | Current |
| 62135-684-60 | 62135068460 | 60 TABLET in 1 BOTTLE (62135-684-60) | 60 tablet | 2022-04-06 | 0000-00-00 | No | No | Current |
| 62135-684-90 | 62135068490 | 90 TABLET in 1 BOTTLE (62135-684-90) | 90 tablet | 2022-04-06 | 0000-00-00 | No | No | Current |