METFORMIN HYDROCHLORIDE
- Product NDC
- 53808-0613
- 11-digit product format
- 538080613
- Labeler code
- 53808
- Product ID
- 53808-0613_93d2b84b-0609-4350-88c9-464b7add33f6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METFORMIN HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- State of Florida DOH Central Pharmacy
- Application
- ANDA077336
- Marketing category
- ANDA
- Marketing start
- 2009-07-01
- Marketing end
- 0000-00-00
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Biguanide [EPC],Biguanides [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53808-0613-1 | METFORMIN HYDROCHLORIDE | 30 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 30 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| METFORMIN HYDROCHLORIDE | ACTIVE INGREDIENT | 786Z46389E | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| METFORMIN | ACTIVE MOIETY | 9100L32L2N | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| HYPROMELLOSE | INACTIVE INGREDIENT | 3NXW29V3WO | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SODIUM CARBONATE | INACTIVE INGREDIENT | 45P3261C7T | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [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 |
|---|
| 53808-0613 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | Legacy NDC, 1 package rows | 20100805_c7a29365-76f1-42dc-9891-e13e54295d52.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53808-0613-1 | 53808061301 | 30 in 1 BLISTER PACK | Historical |