Prescription drug · ANDA
Metformin Hydrochloride NDC 72189-150
Metformin hydrochloride 500 mg/1 · Tablet, Extended release · Oral · direct rx
NDC codes
FDA NDC DirectoryProduct NDC (as listed)72189-150Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72189-0150Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-150-30 | 7218901503072189015030 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-150-30)Marketed from Oct 14, 2020 | |
| 72189-150-90 | 7218901509072189015090 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-150-90)Marketed from Oct 14, 2020 |
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 — 500 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- direct rxNDC labeler code 72189
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078321
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)
- Identifiers
- Product ID 72189-150_2c4ea7fa-b789-8bdf-e063-6394a90a3e5aSPL ID 2c4ea7fa-b789-8bdf-e063-6394a90a3e5aSPL set ID a84cf1a3-3820-cd1b-e053-2995a90acf45RxCUI 860975UNII 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
N472189015030followed by a unit qualifier and the quantityPackage 72189-0150-30. 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 .
Indications (excerpt from the label)
Metformin Hydrochloride Extended-Release Tablets, USP is 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 72189-150
- What is NDC 72189-150?
- 72189-150 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 500 mg/1 tablet, extended release, listed with the FDA by direct rx. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Metformin Hydrochloride.
- What is the active ingredient?
- Metformin hydrochloride.
- Who is the labeler?
- direct rx, NDC labeler code 72189. 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 Hydrochloride?
- 366 other product NDCs are listed under this name. See all Metformin Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Metformin Hydrochloride 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 Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4781 | 70518-4781-00 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Marlex Pharmaceuticals, Inc. | 10135-823 | 10135-0823-0510135-0823-1010135-0823-30+5 more |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Marlex Pharmaceuticals, Inc. | 10135-824 | 10135-0824-0510135-0824-1010135-0824-90 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4185 | 68788-4185-0168788-4185-0368788-4185-06+3 more |
| Metformin Hydrochloride | Metformin hydrochloride 625 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-588 | 50228-0588-0550228-0588-30 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-589 | 50228-0589-0550228-0589-30 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4710 | 70518-4710-0070518-4710-02 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4698 | 70518-4698-00 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0591 | 80425-0591-0180425-0591-0280425-0591-03+1 more |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-054 | 87441-0054-01 |
Other NDCs under ANDA 078321
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, Extended releaseOral | AvPAK | 50268-550 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | AvPAK | 50268-551 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | TAGI Pharma, Inc. | 51224-007 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | TAGI Pharma, Inc. | 51224-107 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 51655-368 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | RedPharm Drug, Inc. | 67296-1701 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Precision Dose, Inc. | 68094-804 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Precision Dose, Inc. | 68094-904 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Preferred Pharmaceuticals Inc. | 68788-8903 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-2709 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4163 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4639 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 71205-141 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 71205-186 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-0720 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-0776 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2504 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-3166 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-533 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-451 |
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