Prescription drug · ANDA
Metformin ER 750 mg NDC 62207-492
Metformin hydrochloride 750 mg/1 · Tablet · Oral · Granules India Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62207-492-40 | 6220704924062207049240 | 3500 TABLET in 1 POUCH (62207-492-40)Marketed from Jun 28, 2018 | |
| 62207-492-43 | 6220704924362207049243 | 100 TABLET in 1 BOTTLE (62207-492-43)Marketed from Jul 25, 2019 | |
| 62207-492-47 | 6220704924762207049247 | 500 TABLET in 1 BOTTLE (62207-492-47)Marketed from Jul 25, 2019 | |
| 62207-492-49 | 6220704924962207049249 | 1000 TABLET in 1 BOTTLE (62207-492-49)Marketed from Jul 25, 2019 | |
| 62207-492-54 | 6220704925462207049254 | 30 TABLET in 1 BOTTLE (62207-492-54)Marketed from Jul 25, 2019 |
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 ER 750 mg
- Generic name (nonproprietary)
- metformin er 750 mg
- Active ingredients
- Metformin hydrochloride — 750 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Granules India LtdNDC labeler code 62207
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209313
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)
- Identifiers
- Product ID 62207-492_56cbdf81-acdf-940c-e063-6394a90ad166SPL ID 56cbdf81-acdf-940c-e063-6394a90ad166SPL set ID b857eccf-b9ff-45ba-8241-f47f5caada2aRxCUI 860975, 860981UNII 786Z46389EUPC 0362207491549
- 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
N462207049240followed by a unit qualifier and the quantityPackage 62207-0492-40. 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 extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablets are biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Excerpt only. Read the full label for complete information.
About NDC 62207-492
- What is NDC 62207-492?
- 62207-492 is the product NDC for Metformin ER 750 mg, Metformin hydrochloride 750 mg/1 tablet, listed with the FDA by Granules India Ltd. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Metformin ER 750 mg.
- What is the active ingredient?
- Metformin hydrochloride.
- Who is the labeler?
- Granules India Ltd, NDC labeler code 62207. 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 ER 750 mg?
- 1 other product NDC are listed under this name. See all Metformin ER 750 mg NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Metformin ER 750 mg 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 ER 750 mg | Metformin hydrochloride 750 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-118 | 82009-0118-01 |
Other NDCs under ANDA 209313
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 |
|---|---|---|---|---|
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-6515 |
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6516 |
| Metforminmetformin er 750 mg | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7372 |
| Metforminmetformin er 750 mg | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7373 |
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-0437 |
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Legacy Pharmaceutical Packaging, LLC | 68645-595 |
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Granules Pharmaceuticals Inc. | 70010-491 |
| Metforminmetformin er 750 mg | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Granules Pharmaceuticals Inc. | 70010-492 |
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4370 |
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2354 |
| Metforminmetformin er 750 mg | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2524 |
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-613 |
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2424 |
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 82804-147 |
| Metformin ER 500 mg | Metformin hydrochloride 500 mg/1 | TabletOral | Granules India Ltd | 62207-491 |
| Metformin ER 500 mg | Metformin hydrochloride 500 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-117 |
| Metformin ER 750 mg | Metformin hydrochloride 750 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-118 |