Prescription drug · ANDA
Metformin Hydrochloride NDC 59651-854
Metformin hydrochloride 500 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC DirectoryProduct NDC (as listed)59651-854Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59651-0854Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-854-01 | 5965108540159651085401 | 100 TABLET, FILM COATED in 1 BOTTLE (59651-854-01)Marketed from Mar 29, 2024 | |
| 59651-854-05 | 5965108540559651085405 | 500 TABLET, FILM COATED in 1 BOTTLE (59651-854-05)Marketed from Mar 29, 2024 | |
| 59651-854-45 | 5965108544559651085445 | 4500 TABLET, FILM COATED in 1 BOTTLE (59651-854-45)Marketed from Mar 29, 2024 | |
| 59651-854-50 | 5965108545059651085450 | 50 TABLET, FILM COATED in 1 BOTTLE (59651-854-50)Marketed from Mar 29, 2024 | |
| 59651-854-60 | 5965108546059651085460 | 60 TABLET, FILM COATED in 1 BOTTLE (59651-854-60)Marketed from Mar 29, 2024 | |
| 59651-854-79 | 5965108547959651085479 | 300 TABLET, FILM COATED in 1 BOTTLE (59651-854-79)Marketed from Mar 29, 2024 | |
| 59651-854-90 | 5965108549059651085490 | 90 TABLET, FILM COATED in 1 BOTTLE (59651-854-90)Marketed from Mar 29, 2024 | |
| 59651-854-99 | 5965108549959651085499 | 1000 TABLET, FILM COATED in 1 BOTTLE (59651-854-99)Marketed from Mar 29, 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, Film coated
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 59651
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077095
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)
- Identifiers
- Product ID 59651-854_a7b61bdd-41e9-4894-8200-07aa5f6d0ed3SPL ID a7b61bdd-41e9-4894-8200-07aa5f6d0ed3SPL set ID fc466c46-abaa-4675-aef2-4b1a1adfd912RxCUI 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
N459651085401followed by a unit qualifier and the quantityPackage 59651-0854-01. 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
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.
About NDC 59651-854
- What is NDC 59651-854?
- 59651-854 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 500 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 8 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Metformin Hydrochloride.
- What is the active ingredient?
- Metformin hydrochloride.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 59651. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Metformin Hydrochloride?
- 366 other product NDCs are listed under this name. See all Metformin Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Metformin Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4781 | 70518-4781-00 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Marlex Pharmaceuticals, Inc. | 10135-823 | 10135-0823-0510135-0823-1010135-0823-30+5 more |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Marlex Pharmaceuticals, Inc. | 10135-824 | 10135-0824-0510135-0824-1010135-0824-90 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4185 | 68788-4185-0168788-4185-0368788-4185-06+3 more |
| Metformin Hydrochloride | Metformin hydrochloride 625 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-588 | 50228-0588-0550228-0588-30 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-589 | 50228-0589-0550228-0589-30 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4710 | 70518-4710-0070518-4710-02 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4698 | 70518-4698-00 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0591 | 80425-0591-0180425-0591-0280425-0591-03+1 more |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-054 | 87441-0054-01 |
Other NDCs under ANDA 077095
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 | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8015 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8577 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8578 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8629 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2081 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5052 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6485 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7868 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-8106 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-649 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-855 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-856 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-238 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-239 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-5313 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-5323 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4185 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1149 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3130 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3132 |
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