Prescription drug · ANDA
metformin hydrochloride (metformin hydrochloride tablets) NDC 42806-405
Metformin hydrochloride 500 mg/1 · Tablet, Film coated, Extended release · Oral · EPIC PHARMA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42806-405-60 | 42806040560 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42806-405-60)Marketed from Jan 4, 2019 |
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 tablets
- Active ingredients
- Metformin hydrochloride — 500 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- EPIC PHARMA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209993
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)
- Identifiers
- Product ID 42806-405_1edb3813-b7cb-4501-ad91-eae58624c836SPL ID 1edb3813-b7cb-4501-ad91-eae58624c836SPL set ID 356b02d0-d239-4441-bb33-c4c54166fcd7RxCUI 1807894, 1807917UNII 786Z46389EUPC 0342806406601, 0342806405604
- 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
N442806040560followed by a unit qualifier and the quantityPackage 42806-0405-60. 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 extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablets are biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209993
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 hydrochloridemetformin hydrochloride tablet | Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | EPIC PHARMA, LLC | 42806-406 |
| Metformin Hydrochloridemetformin hydrochloride extended-release tablets | Metformin hydrochloride 500 mg/1 | Tablet, Film coated, Extended releaseOral | AiPing Pharmaceutical, Inc. | 11788-037 |
| Metformin Hydrochloridemetformin hydrochloride extended-release tablets | Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Qingdao BAHEAL Pharmaceutical Co. Ltd. | 70247-018 |
| Metformin Hydrochloridemetformin hydrochloride extended-release tablets | Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | AiPing Pharmaceutical, Inc. | 11788-038 |
| Metformin Hydrochloridemetformin hydrochloride extended-release tablets | Metformin hydrochloride 500 mg/1 | Tablet, Film coated, Extended releaseOral | Qingdao BAHEAL Pharmaceutical Co. Ltd. | 70247-019 |