Metformin
- Product NDC
- 82804-147
- 11-digit product format
- 828040147
- Labeler code
- 82804
- Product ID
- 82804-147_f71c1195-68bc-435d-abba-f28a10150004
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin ER 500 mg
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA209313
- Marketing category
- ANDA
- Marketing start
- 2018-07-31
- 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
- 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 |
|---|
| 82804-147-30 | Metformin | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 4 |
| 82804-147-60 | Metformin | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 4 |
| 82804-147-78 | Metformin | 180 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 180 | | 4 |
| 82804-147-90 | Metformin | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-147 | METFORMIN (METFORMIN ER 500 MG) TABLET, EXTENDED RELEASE [PROFICIENT RX LP] | 4 | Current NDC, 4 package rows | 20250413_92855c8d-59be-458b-97f1-2ff11b9bf6b0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-147-30 | 82804014730 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-147-30) | 2025-04-08 | No | No | Current |
| 82804-147-60 | 82804014760 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-147-60) | 2024-09-20 | No | No | Current |
| 82804-147-78 | 82804014778 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-147-78) | 2024-10-01 | No | No | Current |
| 82804-147-90 | 82804014790 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-147-90) | 2024-11-04 | No | No | Current |