Prescription drug · ANDA
Glipizide and Metformin Hydrochloride NDC 68382-186
Glipizide 5 mg/1; Metformin hydrochloride 500 mg/1 · Tablet, Film coated · Oral · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68382-186-01 | 6838201860168382018601 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-186-01)Marketed from May 5, 2016 | |
| 68382-186-10 | 6838201861068382018610 | 1000 TABLET, FILM COATED in 1 BOTTLE (68382-186-10)Marketed from May 5, 2016 | |
| 68382-186-16 | 6838201861668382018616 | 90 TABLET, FILM COATED in 1 BOTTLE (68382-186-16)Marketed from May 5, 2016 | |
| 68382-186-77 | 6838201867768382018677 | 10 BLISTER PACK in 1 CARTON (68382-186-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-186-30)Marketed from May 5, 2016 |
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)
- Glipizide and Metformin Hydrochloride
- Generic name (nonproprietary)
- glipizide and metformin hydrochloride
- Active ingredients
- Glipizide — 5 mg/1Metformin hydrochloride — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Zydus Pharmaceuticals USA Inc.NDC labeler code 68382
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078905
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)Sulfonylurea Compounds (Chemical structure)
- Identifiers
- Product ID 68382-186_e66df8de-b76f-4812-9d00-9448cb378858SPL ID e66df8de-b76f-4812-9d00-9448cb378858SPL set ID 1b18b903-eb52-4d08-b4a5-f984957eb116RxCUI 861731, 861736, 861740UNII 786Z46389E, X7WDT95N5CUPC 0368382184016
- Pharmacologic class
- Biguanide; Sulfonylurea
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
N468382018601followed by a unit qualifier and the quantityPackage 68382-0186-01. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Glipizide and metformin hydrochloride tablets, USP are 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 68382-186
- What is NDC 68382-186?
- 68382-186 is the product NDC for Glipizide and Metformin Hydrochloride, Glipizide 5 mg/1; Metformin hydrochloride 500 mg/1 tablet, film coated, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Glipizide and Metformin Hydrochloride.
- What is the active ingredient?
- Glipizide, Metformin hydrochloride.
- Who is the labeler?
- Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Glipizide and Metformin Hydrochloride?
- 13 other product NDCs are listed under this name. See all Glipizide and 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 Glipizide and 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) |
|---|---|---|---|---|---|
| Glipizide and Metformin Hydrochloride | Glipizide 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0373 | 70518-0373-0070518-0373-01 |
| Glipizide and Metformin Hydrochloride | Glipizide 2.5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2492 | 50090-2492-00 |
| Glipizide and Metformin Hydrochloride | Glipizide 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2556 | 50090-2556-00 |
| Glipizide and Metformin Hydrochloride | Glipizide 2.5 mg/1; Metformin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-659 | 65841-0659-0165841-0659-1065841-0659-16+1 more |
| Glipizide and Metformin Hydrochloride | Glipizide 2.5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-660 | 65841-0660-0165841-0660-1065841-0660-16+1 more |
| Glipizide and Metformin Hydrochloride | Glipizide 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-661 | 65841-0661-0165841-0661-1065841-0661-16+1 more |
| Glipizide and Metformin Hydrochloride | Glipizide 2.5 mg/1; Metformin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-184 | 68382-0184-0168382-0184-1068382-0184-16+1 more |
| Glipizide and Metformin Hydrochloride | Glipizide 2.5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-185 | 68382-0185-0168382-0185-1068382-0185-16+1 more |
| Glipizide and Metformin Hydrochloride | Glipizide 2.5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-305 | 42291-0305-01 |
| Glipizide and Metformin Hydrochloride | Glipizide 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-306 | 42291-0306-01 |
Other NDCs under ANDA 078905
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 |
|---|---|---|---|---|
| Glipizide and Metformin Hydrochloride | Glipizide 2.5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2492 |
| Glipizide and Metformin Hydrochloride | Glipizide 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2556 |
| Glipizide and Metformin Hydrochloride | Glipizide 2.5 mg/1; Metformin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-659 |
| Glipizide and Metformin Hydrochloride | Glipizide 2.5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-660 |
| Glipizide and Metformin Hydrochloride | Glipizide 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-661 |
| Glipizide and Metformin Hydrochloride | Glipizide 2.5 mg/1; Metformin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-184 |
| Glipizide and Metformin Hydrochloride | Glipizide 2.5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-185 |