Prescription drug · ANDA
Metformin Hydrochloride NDC 50090-7454
Metformin hydrochloride 1000 mg/1 · Tablet, Coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-7454-0 | 50090745400 | 60 TABLET, COATED in 1 BOTTLE (50090-7454-0)Marketed from Nov 13, 2024 | |
| 50090-7454-2 | 50090745402 | 100 TABLET, COATED in 1 BOTTLE (50090-7454-2)Marketed from Nov 13, 2024 | |
| 50090-7454-3 | 50090745403 | 30 TABLET, COATED in 1 BOTTLE (50090-7454-3)Marketed from Nov 13, 2024 | |
| 50090-7454-4 | 50090745404 | 90 TABLET, COATED in 1 BOTTLE (50090-7454-4)Marketed from Nov 13, 2024 | |
| 50090-7454-5 | 50090745405 | 180 TABLET, COATED in 1 BOTTLE (50090-7454-5)Marketed from Nov 13, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 1000 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205096
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)
- Identifiers
- Product ID 50090-7454_fa439403-22cd-445b-ac1d-8f628c957a21SPL ID fa439403-22cd-445b-ac1d-8f628c957a21SPL set ID 2d2ebf52-3d5e-4fad-b7f7-c9280957574cRxCUI 861004UNII 786Z46389E
- 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
N450090745400followed by a unit qualifier and the quantityPackage 50090-7454-00. 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 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 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 205096
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, CoatedOral | A-S Medication Solutions | 50090-7280 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, CoatedOral | A-S Medication Solutions | 50090-7278 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, CoatedOral | Precision Dose, Inc. | 68094-480 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | Tablet, CoatedOral | Precision Dose, Inc. | 68094-580 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, CoatedOral | A-S Medication Solutions | 50090-7578 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, CoatedOral | Precision Dose, Inc. | 68094-688 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, CoatedOral | Mullan Pharmaceutical Inc. | 83301-0008 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | Tablet, CoatedOral | Mullan Pharmaceutical Inc. | 83301-0009 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, CoatedOral | Mullan Pharmaceutical Inc. | 83301-0010 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | Tablet, CoatedOral | Westminster Pharmaceuticals, LLC | 69367-382 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, CoatedOral | Westminster Pharmaceuticals, LLC | 69367-381 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, CoatedOral | Westminster Pharmaceuticals, LLC | 69367-383 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, CoatedOral | Coupler, LLC | 67046-1554 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, CoatedOral | A-S Medication Solutions | 50090-7455 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, CoatedOral | NuCare Pharmaceuticals, Inc. | 68071-3976 |