Prescription drug · ANDA
Metformin Hydrochloride NDC 68094-688
Metformin hydrochloride 500 mg/1 · Tablet, Coated · Oral · Precision Dose, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68094-688-60 | 68094068860 | 500 TABLET, COATED in 1 BOTTLE (68094-688-60)Marketed from Feb 15, 2024 | |
| 68094-688-70 | 68094068870 | 1000 TABLET, COATED in 1 BOTTLE (68094-688-70)Marketed from Feb 15, 2024 |
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, Coated
- Route
- Oral
- Labeler
- Precision Dose, Inc.
- 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 68094-688_ef55270e-91c5-46cf-89a5-afec4872afa4SPL ID ef55270e-91c5-46cf-89a5-afec4872afa4SPL set ID 37ff1b8e-a434-41c0-82e1-4583842921a5RxCUI 861004, 861007, 861010UNII 786Z46389EUPC 0368094580601, 0368094480604
- 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
N468094068860followed by a unit qualifier and the quantityPackage 68094-0688-60. 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.