Prescription drug · NDA AUTHORIZED GENERIC
Metformin hydrochloride NDC 68682-018
Metformin hydrochloride 1000 mg/1 · Tablet, Film coated, Extended release · Oral · Oceanside Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68682-018-90 | 68682001890 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68682-018-90)Marketed from Jun 17, 2008 |
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 — 1000 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Oceanside Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021748
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)
- Identifiers
- Product ID 68682-018_26e1cf7e-cc48-cc39-e063-6394a90a62ccSPL ID 26e1cf7e-cc48-cc39-e063-6394a90a62ccSPL set ID 74d32a8a-c4c2-4dbb-b376-eea3f8fa64d7RxCUI 1807888, 1807915UNII 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
N468682001890followed by a unit qualifier and the quantityPackage 68682-0018-90. 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 a 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 NDA 021748
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 coated, Extended releaseOral | Oceanside Pharmaceuticals | 68682-021 |
| Glumetzametformin hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coated, Extended releaseOral | Santarus, Inc. | 68012-004 |
| Glumetzametformin hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coated, Extended releaseOral | Santarus, Inc. | 68012-002 |
| Glumetzametformin hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Santarus, Inc. | 68012-003 |