Prescription drug · ANDA
Metformin Hydrochloride NDC 43353-982
Metformin hydrochloride 500 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43353-982-30 | 43353098230 | 30 TABLET in 1 BOTTLE (43353-982-30)Marketed from Nov 11, 2014 | |
| 43353-982-53 | 43353098253 | 60 TABLET in 1 BOTTLE (43353-982-53)Marketed from Nov 16, 2015 | |
| 43353-982-60 | 43353098260 | 90 TABLET in 1 BOTTLE (43353-982-60)Marketed from May 13, 2015 | |
| 43353-982-70 | 43353098270 | 120 TABLET in 1 BOTTLE (43353-982-70)Marketed from May 14, 2019 | |
| 43353-982-80 | 43353098280 | 180 TABLET in 1 BOTTLE (43353-982-80)Marketed from May 12, 2015 | |
| 43353-982-92 | 43353098292 | 270 TABLET in 1 BOTTLE (43353-982-92)Marketed from May 12, 2015 | |
| 43353-982-94 | 43353098294 | 360 TABLET in 1 BOTTLE (43353-982-94)Marketed from May 12, 2015 | |
| 43353-982-96 | 43353098296 | 450 TABLET in 1 BOTTLE (43353-982-96)Marketed from Mar 28, 2015 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203769
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)
- Identifiers
- Product ID 43353-982_4900492c-70fa-e5b5-e063-6294a90af743SPL ID 4900492c-70fa-e5b5-e063-6294a90af743SPL set ID 273d86b0-9d30-48c9-8918-c5e1ececa951RxCUI 861004, 861007, 861010UNII 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
N443353098230followed by a unit qualifier and the quantityPackage 43353-0982-30. 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)
INDICATIONS AND USAGE Metformin hydrochloride tablet are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203769
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, Film coatedOral | REMEDYREPACK INC. | 70518-1951 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-106 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1785 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-105 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-107 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-884 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-882 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-883 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1834 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8504 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1833 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1835 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-112 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-111 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-113 |
| Metformin Hydrochloride | Metformin hydrochloride 625 mg/1 | TabletOral | Method Pharmaceuticals, LLC. | 58657-726 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | TabletOral | Method Pharmaceuticals, LLC. | 58657-727 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | TabletOral | direct rx | 72189-220 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1522 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | direct rx | 72189-219 |
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