Prescription drug · ANDA
Metformin Hydrochloride NDC 43063-527
Metformin hydrochloride 500 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-527-14 | 43063052714 | 14 TABLET in 1 BOTTLE, PLASTIC (43063-527-14)Marketed from May 12, 2017 | |
| 43063-527-20 | 43063052720 | 20 TABLET in 1 BOTTLE, PLASTIC (43063-527-20)Marketed from Sep 16, 2013 | |
| 43063-527-30 | 43063052730 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-527-30)Marketed from Sep 16, 2013 | |
| 43063-527-60 | 43063052760 | 60 TABLET in 1 BOTTLE, PLASTIC (43063-527-60)Marketed from Sep 16, 2013 | |
| 43063-527-90 | 43063052790 | 90 TABLET in 1 BOTTLE, PLASTIC (43063-527-90)Marketed from Sep 16, 2013 | |
| 43063-527-93 | 43063052793 | 180 TABLET in 1 BOTTLE, PLASTIC (43063-527-93)Marketed from Sep 16, 2013 | |
| 43063-527-94 | 43063052794 | 270 TABLET in 1 BOTTLE, PLASTIC (43063-527-94)Marketed from Sep 16, 2013 | |
| 43063-527-98 | 43063052798 | 120 TABLET in 1 BOTTLE, PLASTIC (43063-527-98)Marketed from Sep 16, 2013 |
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
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077880
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)
- Identifiers
- Product ID 43063-527_4138efd9-8582-c8db-e063-6294a90adcd7SPL ID 4138efd9-8582-c8db-e063-6294a90adcd7SPL set ID 0230a3c3-34cf-478b-88c3-4d96e5300018RxCUI 861007UNII 786Z46389EUPC 0343063527207
- 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
N443063052714followed by a unit qualifier and the quantityPackage 43063-0527-14. 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 is 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 077880
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 1000 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-544 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-218 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-219 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-220 |