METFORMIN HYDROCHLORIDE
- Product NDC
- 42385-978
- 11-digit product format
- 423850978
- Labeler code
- 42385
- Product ID
- 42385-978_0e7b02cc-2ddc-4394-a80c-128e6452d697
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METFORMIN HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Laurus Labs Limited
- Application
- ANDA217631
- Marketing category
- ANDA
- Marketing start
- 2023-10-06
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 750 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 | 750 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 860975, 860981 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42385-978-01 | METFORMIN HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 2 |
| 42385-978-05 | METFORMIN HYDROCHLORIDE | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 2 |
| 42385-978-11 | METFORMIN HYDROCHLORIDE | 1000 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1000 | | 2 |
| 42385-978-18 | METFORMIN HYDROCHLORIDE | 180 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 180 | | 2 |
| 42385-978-30 | METFORMIN HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 2 |
| 42385-978-72 | METFORMIN HYDROCHLORIDE | 10 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 10 | | 2 |
| 42385-978-72 | METFORMIN HYDROCHLORIDE | 15 in 1 CARTON | TABLET, EXTENDED RELEASE | 15 | | 2 |
| 42385-978-90 | METFORMIN HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42385-978 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [LAURUS LABS LIMITED] | 1 | Current NDC, 8 package rows | 20231017_0e7b02cc-2ddc-4394-a80c-128e6452d697.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 42385-978-01 | 42385097801 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-978-01) | | 2023-10-06 | No | No | Current |
| 42385-978-05 | 42385097805 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-978-05) | | 2023-10-06 | No | No | Current |
| 42385-978-11 | 42385097811 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-978-11) | | 2023-10-06 | No | No | Current |
| 42385-978-18 | 42385097818 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-978-18) | | 2023-10-06 | No | No | Current |
| 42385-978-30 | 42385097830 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-978-30) | | 2023-10-06 | No | No | Current |
| 42385-978-72 | 42385097872 | 15 BLISTER PACK in 1 CARTON (42385-978-72) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 15 blister pack | 2023-10-06 | No | No | Current |
| 42385-978-90 | 42385097890 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-978-90) | | 2023-10-06 | No | No | Current |