Metformin Hydrochloride
- Product NDC
- 65862-009
- 11-digit product format
- 658620009
- Labeler code
- 65862
- Product ID
- 65862-009_1c59d7bc-6118-4707-80c0-886ac00bab09
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA077095
- Marketing category
- ANDA
- Marketing start
- 2005-01-14
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 850 mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Metformin Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 850 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 861004, 861007, 861010 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65862-009-01 | Metformin Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 16 |
| 65862-009-05 | Metformin Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 16 |
| 65862-009-33 | Metformin Hydrochloride | 300 in 1 BOTTLE | TABLET, FILM COATED | 300 | | 16 |
| 65862-009-44 | Metformin Hydrochloride | 2500 in 1 BOTTLE | TABLET, FILM COATED | 2500 | | 16 |
| 65862-009-50 | Metformin Hydrochloride | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | | 16 |
| 65862-009-60 | Metformin Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 16 |
| 65862-009-90 | Metformin Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 16 |
| 65862-009-99 | Metformin Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 16 |
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 [AUROBINDO PHARMA LIMITED] | 6 | |
| METFORMIN | ACTIVE MOIETY | 9100L32L2N | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
| POVIDONE K90 | INACTIVE INGREDIENT | RDH86HJV5Z | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
| METFORMIN HYDROCHLORIDE | ACTIVE INGREDIENT | 786Z46389E | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| METFORMIN | ACTIVE MOIETY | 9100L32L2N | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| HYPROMELLOSE 2910 (5 CPS) | INACTIVE INGREDIENT | R75537T0T4 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POVIDONE K90 | INACTIVE INGREDIENT | RDH86HJV5Z | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-009 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | Current NDC, Legacy NDC, 8 package rows | 20240104_4ac6d01a-af26-44e7-ae2e-3618de0080aa.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 |
|---|
| 65862-009-01 | 65862000901 | 100 TABLET, FILM COATED in 1 BOTTLE (65862-009-01) | 2005-01-14 | 0000-00-00 | No | No | Current |
| 65862-009-05 | 65862000905 | 500 TABLET, FILM COATED in 1 BOTTLE (65862-009-05) | 2005-01-14 | 0000-00-00 | No | No | Current |
| 65862-009-15 | 65862000915 | 1500 TABLET, FILM COATED in 1 BAG (65862-009-15) | 14-JAN-05 | | | | Current |
| 65862-009-26 | 65862000926 | 2500 TABLET, FILM COATED in 1 BAG (65862-009-26) | 14-JAN-05 | | | | Current |
| 65862-009-33 | 65862000933 | 300 TABLET, FILM COATED in 1 BOTTLE (65862-009-33) | 2005-01-14 | 0000-00-00 | No | No | Current |
| 65862-009-44 | 65862000944 | 2500 TABLET, FILM COATED in 1 BOTTLE (65862-009-44) | 2005-01-14 | 0000-00-00 | No | No | Current |
| 65862-009-50 | 65862000950 | 50 TABLET, FILM COATED in 1 BOTTLE (65862-009-50) | 2005-01-14 | 0000-00-00 | No | No | Current |
| 65862-009-60 | 65862000960 | 60 TABLET, FILM COATED in 1 BOTTLE (65862-009-60) | 2005-01-14 | 0000-00-00 | No | No | Current |
| 65862-009-66 | 65862000966 | 33000 TABLET, FILM COATED in 1 BAG (65862-009-66) | 14-JAN-05 | | | | Current |
| 65862-009-90 | 65862000990 | 90 TABLET, FILM COATED in 1 BOTTLE (65862-009-90) | 2005-01-14 | 0000-00-00 | No | No | Current |
| 65862-009-99 | 65862000999 | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-009-99) | 2005-01-14 | 0000-00-00 | No | No | Current |