Metformin Hydrochloride
- Product NDC
- 82804-195
- 11-digit product format
- 828040195
- Labeler code
- 82804
- Product ID
- 82804-195_7cb47c3e-6657-4c11-8aa2-ae172e5a8529
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA078321
- Marketing category
- ANDA
- Marketing start
- 2024-02-15
- 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 |
|---|
| 82804-195-60 | Metformin Hydrochloride | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-195 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PROFICIENT RX LP] | 1 | Current NDC, 1 package rows | 20250221_7cb47c3e-6657-4c11-8aa2-ae172e5a8529.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-195-60 | 82804019560 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-195-60) | 2025-02-10 | No | No | Current |