Metformin Hydrochloride
- Product NDC
- 53808-0848
- 11-digit product format
- 538080848
- Labeler code
- 53808
- Product ID
- 53808-0848_4fb8b0cb-c11c-4a61-89b1-7296991ec647
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- State of Florida DOH Central Pharmacy
- Application
- ANDA077095
- Marketing category
- ANDA
- Marketing start
- 2012-01-01
- Marketing end
- 0000-00-00
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 1000 mg/1
- Pharmacologic classes
- Biguanide [EPC],Biguanides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53808-0848-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-2a90-f424-e053-dadaa90a57ce | Metformin Hydrochloride Tablets, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53808-0848-1 | Metformin Hydrochloride | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | 2 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| METFORMIN HYDROCHLORIDE | ACTIVE INGREDIENT | 786Z46389E | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| METFORMIN | ACTIVE MOIETY | 9100L32L2N | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| POVIDONE K90 | INACTIVE INGREDIENT | RDH86HJV5Z | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53808-0848 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | Legacy NDC, 1 package rows | 20140418_57066c55-7841-4b0b-a2a6-15c14e6e5955.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 861004 | metFORMIN HCl 1000 MG Oral Tablet | PSN | 57066c55-7841-4b0b-a2a6-15c14e6e5955 | 2 |
| 861004 | metformin hydrochloride 1000 MG Oral Tablet | SCD | 57066c55-7841-4b0b-a2a6-15c14e6e5955 | 2 |
| 861004 | metformin HCl 1 GM Oral Tablet | SY | 57066c55-7841-4b0b-a2a6-15c14e6e5955 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 53808-0848-1 | 53808084801 | 30 in 1 BLISTER PACK | Historical |