Metformin Hydrochloride
- Product NDC
- 0615-8577
- 11-digit product format
- 006158577
- Labeler code
- 0615
- Product ID
- 0615-8577_eda81df8-05d9-4eac-b058-7eb51d7aa6e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA077095
- Marketing category
- ANDA
- Marketing start
- 2024-03-29
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 850 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 | 850 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 861004, 861007, 861010 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8577-39 | Metformin Hydrochloride | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8577 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 3 | Current NDC, 1 package rows | 20250423_0448c618-2f0d-4ed3-866f-74b413cf902d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0615-8577-39 | 00615857739 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8577-39) | 2025-04-18 | No | No | Historical |