Metformin Hydrochloride
- Product NDC
- 68180-337
- 11-digit product format
- 681800337
- Labeler code
- 68180
- Product ID
- 68180-337_3d9b7d79-d15c-46da-a503-308fb11b558b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA090692
- Marketing category
- ANDA
- Marketing start
- 2011-09-30
- 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 | 1807894, 1807917 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68180-337-01 | Metformin Hydrochloride | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 15 |
| 68180-337-02 | Metformin Hydrochloride | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 15 |
| 68180-337-07 | Metformin Hydrochloride | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-337 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 11 | Current NDC, Legacy NDC, 3 package rows | 20231109_2a84c550-aed8-4058-961f-351a5e4cf7a1.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 |
|---|
| 68180-337-01 | 68180033701 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-337-01) | 2011-09-30 | 0000-00-00 | No | No | Current |
| 68180-337-02 | 68180033702 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-337-02) | 2011-09-30 | 0000-00-00 | No | No | Current |
| 68180-337-07 | 68180033707 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-337-07) | 2011-09-30 | 0000-00-00 | No | No | Current |