Prescription drug · ANDA
Metformin (Metformin er 500 mg) NDC 70010-491
Metformin hydrochloride 500 mg/1 · Tablet, Extended release · Oral · Granules Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70010-491-01 | 7001004910170010049101 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-491-01)Marketed from Jul 31, 2018 | |
| 70010-491-05 | 7001004910570010049105 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-491-05)Marketed from Jul 31, 2018 | |
| 70010-491-09 | 7001004910970010049109 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-491-09)Marketed from Apr 16, 2020 | |
| 70010-491-10 | 7001004911070010049110 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-491-10)Marketed from Jul 31, 2018 | |
| 70010-491-18 | 7001004911870010049118 | 5000 TABLET, EXTENDED RELEASE in 1 POUCH (70010-491-18)Marketed from Jun 14, 2019 | |
| 70010-491-19 | 7001004911970010049119 | 25000 TABLET, EXTENDED RELEASE in 1 CARTON (70010-491-19)Marketed from Jun 14, 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
- Generic name (nonproprietary)
- metformin er 500 mg
- Active ingredients
- Metformin hydrochloride — 500 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Granules Pharmaceuticals Inc.NDC labeler code 70010
- 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 70010-491_537f5fd2-89a1-d029-e063-6394a90a9d0eSPL ID 537f5fd2-89a1-d029-e063-6394a90a9d0eSPL set ID 6d6ee6f8-9650-ff4f-e053-2991aa0acf19RxCUI 860975, 860981UNII 786Z46389EUPC 0370010491038, 0370010492035
- 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
N470010049101followed by a unit qualifier and the quantityPackage 70010-0491-01. 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 extended-release 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 extended-release tablets are 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 70010-491
- What is NDC 70010-491?
- 70010-491 is the product NDC for Metformin (metformin er 500 mg), Metformin hydrochloride 500 mg/1 tablet, extended release, listed with the FDA by Granules Pharmaceuticals Inc.. It has 6 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Metformin (Metformin ER 500 mg).
- What is the active ingredient?
- Metformin hydrochloride.
- Who is the labeler?
- Granules Pharmaceuticals Inc., NDC labeler code 70010. 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?
- 18 other product NDCs are listed under this name. See all Metformin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Metformin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-0437 | 67046-0437-03 |
| Metformin | Metformin hydrochloride 1000 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4651 | 70518-4651-00 |
| Metformin | Metformin hydrochloride 1000 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1584 | 67046-1584-03 |
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4370 | 70518-4370-0070518-4370-0170518-4370-03+1 more |
| Metformin | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1557 | 67046-1557-03 |
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Legacy Pharmaceutical Packaging, LLC | 68645-595 | 68645-0595-59 |
| Metformin | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-633 | 50742-0633-1050742-0633-6050742-0633-90 |
| Metformin | Metformin hydrochloride 1000 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-634 | 50742-0634-1050742-0634-3050742-0634-60 |
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-6515 | 50090-6515-0050090-6515-0150090-6515-02+2 more |
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6516 | 50090-6516-00 |
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 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 | Granules India Ltd | 62207-492 |
| Metformin ER 750 mg | Metformin hydrochloride 750 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-118 |