Metformin Hydrochloride
- Product NDC
- 42385-948
- 11-digit product format
- 423850948
- Labeler code
- 42385
- Product ID
- 42385-948_d2500c46-4274-4a87-b4bf-3a3bfc361630
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Laurus Labs Limited
- Application
- ANDA209882
- Marketing category
- ANDA
- Marketing start
- 2021-05-17
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 850 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
- 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 |
|---|
| 42385-948-01 | Metformin Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 7 |
| 42385-948-05 | Metformin Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 7 |
| 42385-948-11 | Metformin Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 7 |
| 42385-948-18 | Metformin Hydrochloride | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 7 |
| 42385-948-19 | Metformin Hydrochloride | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 7 |
| 42385-948-19 | Metformin Hydrochloride | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 7 |
| 42385-948-90 | Metformin Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42385-948 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [LAURUS LABS LIMITED] | 5 | Current NDC, Legacy NDC, 7 package rows | 20230922_c3dfa8a1-d10a-4a1a-8eba-5f4e2a5a2949.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 |
|---|
| 42385-948-01 | 42385094801 | 100 TABLET, FILM COATED in 1 BOTTLE (42385-948-01) | | 2021-07-20 | 0000-00-00 | No | No | Current |
| 42385-948-05 | 42385094805 | 500 TABLET, FILM COATED in 1 BOTTLE (42385-948-05) | | 2021-07-20 | 0000-00-00 | No | No | Current |
| 42385-948-11 | 42385094811 | 1000 TABLET, FILM COATED in 1 BOTTLE (42385-948-11) | | 2021-05-17 | 0000-00-00 | No | No | Current |
| 42385-948-18 | 42385094818 | 180 TABLET, FILM COATED in 1 BOTTLE (42385-948-18) | | 2021-07-20 | 0000-00-00 | No | No | Current |
| 42385-948-19 | 42385094819 | 10 BLISTER PACK in 1 CARTON (42385-948-19) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2021-05-17 | 0000-00-00 | No | No | Current |
| 42385-948-90 | 42385094890 | 90 TABLET, FILM COATED in 1 BOTTLE (42385-948-90) | | 2021-05-17 | 0000-00-00 | No | No | Current |