Prescription drug · ANDA
Metformin Hydrochloride NDC 42385-947
Metformin hydrochloride 500 mg/1 · Tablet, Film coated · Oral · Laurus Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42385-947-01 | 42385094701 | 100 TABLET, FILM COATED in 1 BOTTLE (42385-947-01)Marketed from Jul 20, 2021 | |
| 42385-947-05 | 42385094705 | 500 TABLET, FILM COATED in 1 BOTTLE (42385-947-05)Marketed from Jul 20, 2021 | |
| 42385-947-11 | 42385094711 | 1000 TABLET, FILM COATED in 1 BOTTLE (42385-947-11)Marketed from May 17, 2021 | |
| 42385-947-18 | 42385094718 | 180 TABLET, FILM COATED in 1 BOTTLE (42385-947-18)Marketed from Jul 20, 2021 | |
| 42385-947-19 | 42385094719 | 10 BLISTER PACK in 1 CARTON (42385-947-19) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 17, 2021 | |
| 42385-947-90 | 42385094790 | 90 TABLET, FILM COATED in 1 BOTTLE (42385-947-90)Marketed from May 17, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Metformin Hydrochloride
- Generic name (nonproprietary)
- metformin hydrochloride
- Active ingredients
- Metformin hydrochloride — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Laurus Labs Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209882
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)
- Identifiers
- Product ID 42385-947_4afe5891-539c-4299-a96a-4a6bfcc22407SPL ID 4afe5891-539c-4299-a96a-4a6bfcc22407SPL set ID c3dfa8a1-d10a-4a1a-8eba-5f4e2a5a2949RxCUI 861004, 861007, 861010UNII 786Z46389EUPC 0342385949605, 0342385948905, 0342385949100, 0342385948103
- Pharmacologic class
- Biguanide
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N442385094701followed by a unit qualifier and the quantityPackage 42385-0947-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Metformin hydrochloride tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin hydrochloride tablets, USP are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209882
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8498 |
| Metformin HCL | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-658 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7106 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7107 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8600 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-644 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6857 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6856 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | Tablet, Film coatedOral | Laurus Labs Limited | 42385-948 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6858 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6859 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Laurus Labs Limited | 42385-949 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2224 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1594 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4262 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2533 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2593 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7866 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8756 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3833 |