Prescription drug · ANDA
Metformin Hydrochloride NDC 67877-221
Metformin hydrochloride 1000 mg/1 · Tablet, Film coated · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-221-01 | 6787702210167877022101 | 100 TABLET, FILM COATED in 1 BOTTLE (67877-221-01)Marketed from Jan 31, 2011 | |
| 67877-221-05 | 6787702210567877022105 | 500 TABLET, FILM COATED in 1 BOTTLE (67877-221-05)Marketed from Jan 31, 2011 | |
| 67877-221-10 | 6787702211067877022110 | 1000 TABLET, FILM COATED in 1 BOTTLE (67877-221-10)Marketed from Jan 31, 2011 | |
| 67877-221-38 | 6787702213867877022138 | 10 BLISTER PACK in 1 CARTON (67877-221-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-221-33)Marketed from Jan 31, 2011 |
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
- Route
- Oral
- Labeler
- Ascend Laboratories, LLCNDC labeler code 67877
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091184
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)
- Identifiers
- Product ID 67877-221_4fa6bd66-7f2c-4b63-9809-be460cbc2527SPL ID 4fa6bd66-7f2c-4b63-9809-be460cbc2527SPL set ID 0ff1ba75-3c86-4baf-a6b1-1bb883839866RxCUI 860975, 860981, 861004, 861007, 861010UNII 786Z46389EUPC 0367877221014, 0367877218014, 0367877414904, 0367877413907
- 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
N467877022101followed by a unit qualifier and the quantityPackage 67877-0221-01. 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 tablets is 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 is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin is a 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 ) Metformin is 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.
About NDC 67877-221
- What is NDC 67877-221?
- 67877-221 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 1000 mg/1 tablet, film coated, listed with the FDA by Ascend Laboratories, LLC. It has 4 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?
- Ascend Laboratories, LLC, NDC labeler code 67877. 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 091184
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 coatedOral | Ascend Laboratories, LLC | 67877-217 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-218 |