METFORMIN HYDROCHLORIDE
- Product NDC
- 0615-8289
- 11-digit product format
- 006158289
- Labeler code
- 0615
- Product ID
- 0615-8289_e3d84126-2927-4507-aaef-6fc37fc5b105
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metformin hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA201991
- Marketing category
- ANDA
- Marketing start
- 2013-03-01
- 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
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8289-28 | METFORMIN HYDROCHLORIDE | 28 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 28 | | 7 |
| 0615-8289-39 | METFORMIN HYDROCHLORIDE | 30 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8289 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240828_5bb945c1-954a-4d43-aa24-33767d19c57c.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 |
|---|
| 0615-8289-28 | 00615828928 | 28 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8289-28) | 2024-03-28 | | No | No | Current |
| 0615-8289-39 | 00615828939 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8289-39) | 2019-06-10 | 0000-00-00 | No | No | Current |