Metformin Hydrochloride
- Product NDC
- 47335-305
- 11-digit product format
- 473350305
- Labeler code
- 47335
- Product ID
- 47335-305_33ab529d-b535-4138-9c3d-dbde05d702c9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA202917
- Marketing category
- ANDA
- Marketing start
- 2018-05-22
- 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 | 1807888, 1807915 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 47335-305-18 | Metformin Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 1000 | | 11 |
| 47335-305-83 | Metformin Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 11 |
| 47335-305-88 | Metformin Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-305 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 11 | Current NDC, Legacy NDC, 3 package rows | 20240112_52c18b5c-2322-4b22-a36e-3c573d609dd0.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 |
|---|
| 47335-305-18 | 47335030518 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-305-18) | 2018-05-22 | 0000-00-00 | No | No | Current |
| 47335-305-83 | 47335030583 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-305-83) | 2018-05-22 | 0000-00-00 | No | No | Current |
| 47335-305-88 | 47335030588 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-305-88) | 2018-05-22 | 0000-00-00 | No | No | Current |