Prescription drug · ANDA
Metformin HCl NDC 49483-622
Metformin hydrochloride 500 mg/1 · Tablet, Film coated · Oral · TIME CAP LABORATORIES, INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49483-622-01 | 49483062201 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-622-01)Marketed from Nov 16, 2016 | |
| 49483-622-10 | 49483062210 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-622-10)Marketed from Jun 5, 2017 | |
| 49483-622-50 | 49483062250 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-622-50)Marketed from Nov 16, 2016 | |
| 49483-622-81 | 49483062281 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-622-81)Marketed from Jun 5, 2017 |
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 HCl
- Generic name (nonproprietary)
- metformin hcl
- Active ingredients
- Metformin hydrochloride — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- TIME CAP LABORATORIES, INC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090888
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)
- Identifiers
- Product ID 49483-622_2dc48b61-581f-fe5c-e063-6394a90aa557SPL ID 2dc48b61-581f-fe5c-e063-6394a90aa557SPL set ID 542cec22-eeae-4704-9bb6-4176640e5ea8RxCUI 861004, 861007, 861010UNII 786Z46389EUPC 0349483622102, 0349483621013, 0349483621105, 0349483621815, 0349483622812, 0349483620818, 0349483622010, 0349483620016
- 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
N449483062201followed by a unit qualifier and the quantityPackage 49483-0622-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 090888
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 HCl | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | TIME CAP LABORATORIES, INC | 49483-620 |
| Metformin HCl | Metformin hydrochloride 850 mg/1 | Tablet, Film coatedOral | TIME CAP LABORATORIES, INC | 49483-621 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | Tablet, Film coatedOral | MARKSANS PHARMA LIMITED | 25000-131 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | MARKSANS PHARMA LIMITED | 25000-132 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | MARKSANS PHARMA LIMITED | 25000-134 |