Prescription drug · ANDA
Metformin Hydrochloride NDC 71335-3132
Metformin hydrochloride 500 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-3132-0 | 71335313200 | 25 TABLET, FILM COATED in 1 BOTTLE (71335-3132-0)Marketed from Aug 26, 2026 | |
| 71335-3132-1 | 71335313201 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-3132-1)Marketed from Aug 3, 2026 | |
| 71335-3132-2 | 71335313202 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-3132-2)Marketed from Jul 6, 2026 | |
| 71335-3132-3 | 71335313203 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-3132-3)Marketed from Jul 22, 2026 | |
| 71335-3132-4 | 71335313204 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-3132-4)Marketed from Aug 26, 2026 | |
| 71335-3132-5 | 71335313205 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-3132-5)Marketed from May 12, 2026 | |
| 71335-3132-6 | 71335313206 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-3132-6)Marketed from Aug 26, 2026 | |
| 71335-3132-7 | 71335313207 | 56 TABLET, FILM COATED in 1 BOTTLE (71335-3132-7)Marketed from Aug 26, 2026 | |
| 71335-3132-8 | 71335313208 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-3132-8)Marketed from Aug 26, 2026 | |
| 71335-3132-9 | 71335313209 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-3132-9)Marketed from Aug 26, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Bryant Ranch Prepack
- 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 71335-3132_f068e7b8-5ddc-4b75-92da-4ba1928768e4SPL ID f068e7b8-5ddc-4b75-92da-4ba1928768e4SPL set ID fb296500-55cb-45ce-be0c-59aa2e3d4624RxCUI 861007UNII 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
N471335313200followed by a unit qualifier and the quantityPackage 71335-3132-00. 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 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 1000 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4185 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7868 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-239 |
| 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 | REMEDYREPACK INC. | 70518-3130 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-854 |
| 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 | 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 850 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8577 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1149 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-649 |
| 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 | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8578 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-009 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-008 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-010 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8015 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-5313 |
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