METFORMIN HYDROCHLORIDE EXTENDED RELEASE
- Product NDC
- 68071-3111
- 11-digit product format
- 680713111
- Labeler code
- 68071
- Product ID
- 68071-3111_1d9eaa76-848f-a471-e063-6394a90aef30
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METFORMIN HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA090295
- Marketing category
- ANDA
- Marketing start
- 2016-05-12
- 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 EXTENDED RELEASE
- 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 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3111-2 | METFORMIN HYDROCHLORIDE EXTENDED RELEASE | 120 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 120 | | 5 |
| 68071-3111-3 | METFORMIN HYDROCHLORIDE EXTENDED RELEASE | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 5 |
| 68071-3111-6 | METFORMIN HYDROCHLORIDE EXTENDED RELEASE | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 5 |
| 68071-3111-8 | METFORMIN HYDROCHLORIDE EXTENDED RELEASE | 180 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 180 | | 5 |
| 68071-3111-9 | METFORMIN HYDROCHLORIDE EXTENDED RELEASE | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3111 | METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [NUCARE PHARMACEUTICALS, INC.] | 5 | Current NDC, Legacy NDC, 5 package rows | 20240720_4a53ea53-3052-614b-e054-00144ff8d46c.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 |
|---|
| 68071-3111-2 | 68071311102 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-3111-2) | 2017-03-09 | 0000-00-00 | No | No | Current |
| 68071-3111-3 | 68071311103 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-3111-3) | 2017-03-09 | 0000-00-00 | No | No | Current |
| 68071-3111-6 | 68071311106 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-3111-6) | 2017-03-09 | 0000-00-00 | No | No | Current |
| 68071-3111-8 | 68071311108 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-3111-8) | 2017-03-09 | 0000-00-00 | No | No | Current |
| 68071-3111-9 | 68071311109 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-3111-9) | 2017-03-09 | 0000-00-00 | No | No | Current |