METFORMIN HYDROCHLORIDE
- Product NDC
- 65841-810
- 11-digit product format
- 658410810
- Labeler code
- 65841
- Product ID
- 65841-810_f845896f-d006-4f67-9de6-a734ca665025
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METFORMIN HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA203686
- Marketing category
- ANDA
- Marketing start
- 2014-12-09
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 850 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 | 850 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 860975, 861004, 861010 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65841-810-01 | METFORMIN HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 14 |
| 65841-810-05 | METFORMIN HYDROCHLORIDE | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 14 |
| 65841-810-10 | METFORMIN HYDROCHLORIDE | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 14 |
| 65841-810-16 | METFORMIN HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 14 |
| 65841-810-30 | METFORMIN HYDROCHLORIDE | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 14 |
| 65841-810-77 | METFORMIN HYDROCHLORIDE | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| METFORMIN HYDROCHLORIDE | ACTIVE INGREDIENT | 786Z46389E | METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED] | 4 | |
| METFORMIN | ACTIVE MOIETY | 9100L32L2N | METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED] | 4 | |
| GLYCERYL BEHENATE | INACTIVE INGREDIENT | R8WTH25YS2 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED] | 4 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED] | 4 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED] | 4 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65841-810 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] | 14 | Current NDC, Legacy NDC, 6 package rows | 20241207_5043d03e-3c9d-4c96-b48d-187f02a1d27c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65841-810-01 | 65841081001 | 100 TABLET, FILM COATED in 1 BOTTLE (65841-810-01) | | 2014-12-09 | 0000-00-00 | No | No | Current |
| 65841-810-05 | 65841081005 | 500 TABLET, FILM COATED in 1 BOTTLE (65841-810-05) | | 2014-12-09 | 0000-00-00 | No | No | Current |
| 65841-810-10 | 65841081010 | 1000 TABLET, FILM COATED in 1 BOTTLE (65841-810-10) | | 2014-12-09 | 0000-00-00 | No | No | Current |
| 65841-810-16 | 65841081016 | 90 TABLET, FILM COATED in 1 BOTTLE (65841-810-16) | | 2014-12-09 | 0000-00-00 | No | No | Current |
| 65841-810-30 | 65841081030 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 65841-810-77 | 65841081077 | 100 BLISTER PACK in 1 CARTON (65841-810-77) / 1 TABLET, FILM COATED in 1 BLISTER PACK (65841-810-30) | 100 blister pack | 2014-12-09 | 0000-00-00 | No | No | Current |