Metformin
- Product NDC
- 71335-2354
- 11-digit product format
- 713352354
- Labeler code
- 71335
- Product ID
- 71335-2354_79d66c47-1f73-460c-b21a-752d2a8155da
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin ER 500 mg
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- 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 |
|---|
| 71335-2354-1 | Metformin | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 101 |
| 71335-2354-2 | Metformin | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 101 |
| 71335-2354-3 | Metformin | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 101 |
| 71335-2354-4 | Metformin | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 101 |
| 71335-2354-5 | Metformin | 120 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 120 | | 101 |
| 71335-2354-6 | Metformin | 15 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 15 | | 101 |
| 71335-2354-7 | Metformin | 45 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 45 | | 101 |
| 71335-2354-8 | Metformin | 180 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 180 | | 101 |
| 71335-2354-9 | Metformin | 20 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 20 | | 101 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-2354 | METFORMIN (METFORMIN ER 500 MG) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] | 101 | Current NDC, 9 package rows | 20240906_1f823d36-c7a6-4cf8-b6f1-52b7a51c8fc4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2354-1 | 71335235401 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2354-1) | 2024-05-22 | No | No | Historical |
| 71335-2354-2 | 71335235402 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2354-2) | 2024-05-24 | No | No | Historical |
| 71335-2354-3 | 71335235403 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2354-3) | 2024-03-12 | No | No | Historical |
| 71335-2354-4 | 71335235404 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2354-4) | 2024-02-07 | No | No | Historical |
| 71335-2354-5 | 71335235405 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2354-5) | 2024-04-11 | No | No | Historical |
| 71335-2354-6 | 71335235406 | 15 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2354-6) | 2024-04-02 | No | No | Historical |
| 71335-2354-7 | 71335235407 | 45 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2354-7) | 2024-08-26 | No | No | Historical |
| 71335-2354-8 | 71335235408 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2354-8) | 2024-08-26 | No | No | Historical |
| 71335-2354-9 | 71335235409 | 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2354-9) | 2024-08-26 | No | No | Historical |