Metformin Hydrochloride
- Product NDC
- 0378-6001
- 11-digit product format
- 003786001
- Labeler code
- 0378
- Product ID
- 0378-6001_7c8e06cd-8ef3-4a03-b4ee-3df6899280cf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metformin
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA200690
- Marketing category
- ANDA
- Marketing start
- 2016-08-23
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-6001-91 | Metformin Hydrochloride | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 60 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-6001 | METFORMIN HYDROCHLORIDE (METFORMIN) TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 7 | Current NDC, Legacy NDC, 1 package rows | 20190208_7e41818c-60e9-4bcf-9586-7bb8d33d5e89.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 |
|---|
| 0378-6001-91 | 00378600191 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-6001-91) | 2016-08-23 | 0000-00-00 | No | No | Current |