Metformin hydrochloride
- Product NDC
- 33342-239
- 11-digit product format
- 333420239
- Labeler code
- 33342
- Product ID
- 33342-239_3ce6010c-10dd-4e6f-9517-d71c0489a7c5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA206955
- Marketing category
- ANDA
- Marketing start
- 2016-12-08
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 500 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 | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 860975, 860981, 861004, 861007, 861010 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 33342-239-11 | Metformin hydrochloride | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33342-239 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [MACLEODS PHARMACEUTICALS LIMITED] | 6 | Current NDC, Legacy NDC, 1 package rows | 20230204_623b3bc6-1b07-4a04-bc7a-7fc695adf063.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 33342-239-11 | 33342023911 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-239-11) | 2016-12-08 | 0000-00-00 | No | No | Current |