Prescription drug · ANDA
Metformin Hydrochloride NDC 70247-018
metformin hydrochloride extended-release tablets · Metformin hydrochloride 1000 mg/1 · Tablet, Film coated, Extended release · Oral · Qingdao BAHEAL Pharmaceutical Co. Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70247-018-60 | 70247001860 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70247-018-60)Marketed from Dec 27, 2018 |
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 extended-release tablets
- Active ingredients
- Metformin hydrochloride — 1000 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209993
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)
- Identifiers
- Product ID 70247-018_53f09425-9050-34b0-e063-6394a90a3fb7SPL ID 53f09425-9050-34b0-e063-6394a90a3fb7SPL set ID 7ea6e623-4073-4671-e053-2a91aa0a3ca3RxCUI 1807894, 1807917UNII 786Z46389EUPC 0370247018602, 0370247019609
- 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
N470247001860followed by a unit qualifier and the quantityPackage 70247-0018-60. 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. (1)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209993
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 hydrochloridemetformin hydrochloride tablet | Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | EPIC PHARMA, LLC | 42806-406 |
| metformin hydrochloridemetformin hydrochloride tablets | Metformin hydrochloride 500 mg/1 | Tablet, Film coated, Extended releaseOral | EPIC PHARMA, LLC | 42806-405 |
| Metformin Hydrochloridemetformin hydrochloride extended-release tablets | Metformin hydrochloride 500 mg/1 | Tablet, Film coated, Extended releaseOral | AiPing Pharmaceutical, Inc. | 11788-037 |
| Metformin Hydrochloridemetformin hydrochloride extended-release tablets | Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | AiPing Pharmaceutical, Inc. | 11788-038 |
| Metformin Hydrochloridemetformin hydrochloride extended-release tablets | Metformin hydrochloride 500 mg/1 | Tablet, Film coated, Extended releaseOral | Qingdao BAHEAL Pharmaceutical Co. Ltd. | 70247-019 |