METFORMIN HYDROCHLORIDE EXTENDED RELEASE
- Product NDC
- 71335-0889
- 11-digit product format
- 713350889
- Labeler code
- 71335
- Product ID
- 71335-0889_0989899e-34d0-4cdd-b52b-07a96c8826f7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METFORMIN HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA090295
- Marketing category
- ANDA
- Marketing start
- 2016-05-12
- 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 EXTENDED RELEASE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 750 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 860981 |
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 |
|---|
| 71335-0889-1 | METFORMIN HYDROCHLORIDE EXTENDED RELEASE | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 101 |
| 71335-0889-2 | METFORMIN HYDROCHLORIDE EXTENDED RELEASE | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 101 |
| 71335-0889-3 | METFORMIN HYDROCHLORIDE EXTENDED RELEASE | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 101 |
| 71335-0889-4 | METFORMIN HYDROCHLORIDE EXTENDED RELEASE | 180 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 180 | | 101 |
| 71335-0889-5 | METFORMIN HYDROCHLORIDE EXTENDED RELEASE | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 101 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-0889 | METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] | 101 | Current NDC, Legacy NDC, 5 package rows | 20250331_d7c1ff9e-4faa-4f65-9c87-e8108499791f.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 |
|---|
| 71335-0889-1 | 71335088901 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0889-1) | 2022-03-16 | 0000-00-00 | No | No | Current |
| 71335-0889-2 | 71335088902 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0889-2) | 2022-03-16 | 0000-00-00 | No | No | Current |
| 71335-0889-3 | 71335088903 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0889-3) | 2022-03-16 | 0000-00-00 | No | No | Current |
| 71335-0889-4 | 71335088904 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0889-4) | 2022-03-16 | 0000-00-00 | No | No | Current |
| 71335-0889-5 | 71335088905 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0889-5) | 2022-03-16 | 0000-00-00 | No | No | Current |