Prescription drug · ANDA
Glyburide and Metformin Hydrochloride NDC 71335-0360
Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC DirectoryProduct NDC (as listed)71335-0360Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-0360Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0360-1 | 7133503600171335036001 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-0360-1)Marketed from Jun 8, 2018 | |
| 71335-0360-3 | 7133503600371335036003 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-0360-3)Marketed from Mar 16, 2018 | |
| 71335-0360-4 | 7133503600471335036004 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-0360-4)Marketed from Oct 29, 2018 | |
| 71335-0360-5 | 7133503600571335036005 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-0360-5)Marketed from Aug 18, 2026 | |
| 71335-0360-6 | 7133503600671335036006 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-0360-6)Marketed from Feb 26, 2018 | |
| 71335-0360-7 | 7133503600771335036007 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-0360-7)Marketed from Aug 18, 2026 | |
| 71335-0360-8 | 7133503600871335036008 | 25 TABLET, FILM COATED in 1 BOTTLE (71335-0360-8)Marketed from Mar 30, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Glyburide and Metformin Hydrochloride
- Generic name (nonproprietary)
- glyburide and metformin hydrochloride
- Active ingredients
- Glyburide — 5 mg/1Metformin hydrochloride — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077870
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)Sulfonylurea Compounds (Chemical structure)
- Identifiers
- Product ID 71335-0360_36bb4bba-545a-4786-b2a9-7281de0f7c09SPL ID 36bb4bba-545a-4786-b2a9-7281de0f7c09SPL set ID 4dcef36f-000e-43f5-8d67-0e2a079ab2c6RxCUI 861753UNII SX6K58TVWC, 786Z46389E
- 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
N471335036001followed by a unit qualifier and the quantityPackage 71335-0360-01. 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)
Glyburide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glyburide and metformin hydrochloride tablets are a combination of glyburide, a sulfonylurea, and metformin hydrochloride (HCl), 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 71335-0360
- What is NDC 71335-0360?
- 71335-0360 is the product NDC for Glyburide and Metformin Hydrochloride, Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 7 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Glyburide and Metformin Hydrochloride.
- What is the active ingredient?
- Glyburide, Metformin hydrochloride.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Glyburide and Metformin Hydrochloride?
- 20 other product NDCs are listed under this name. See all Glyburide 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 Glyburide 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) |
|---|---|---|---|---|---|
| Glyburide and Metformin Hydrochloride | Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8634 | 68788-8634-0168788-8634-0368788-8634-06+2 more |
| Glyburide and Metformin Hydrochloride | Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8341 | 68788-8341-0168788-8341-0368788-8341-06+2 more |
| Glyburide and Metformin Hydrochloride | Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-942 | 51655-0942-26 |
| Glyburide and Metformin Hydrochloride | Glyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-7180 | 68788-7180-0168788-7180-0368788-7180-06+1 more |
| glyburide and metformin hydrochloride | Glyburide 1.25 mg/1; Metformin hydrochloride 250 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-824 | 65841-0824-0165841-0824-0565841-0824-06+3 more |
| glyburide and metformin hydrochloride | Glyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-825 | 65841-0825-0165841-0825-0565841-0825-06+3 more |
| glyburide and metformin hydrochloride | Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-826 | 65841-0826-0165841-0826-0565841-0826-06+3 more |
| glyburide and metformin hydrochloride | Glyburide 1.25 mg/1; Metformin hydrochloride 250 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 68382-653 | 68382-0653-0168382-0653-0568382-0653-06+3 more |
| glyburide and metformin hydrochloride | Glyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 68382-654 | 68382-0654-0168382-0654-0568382-0654-06+3 more |
| glyburide and metformin hydrochloride | Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 68382-655 | 68382-0655-0168382-0655-0568382-0655-06+3 more |
Other NDCs under ANDA 077870
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 |
|---|---|---|---|---|
| Glyburide and Metformin Hydrochloride | Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2030 |
| Glyburide and Metformin Hydrochloride | Glyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2031 |
| Glyburide and Metformin Hydrochloride | Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-942 |
| Glyburide and Metformin Hydrochloride | Glyburide 1.25 mg/1; Metformin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-023 |
| Glyburide and Metformin Hydrochloride | Glyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-024 |
| Glyburide and Metformin Hydrochloride | Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-025 |
| Glyburide and Metformin Hydrochloride | Glyburide 1.25 mg/1; Metformin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-080 |
| Glyburide and Metformin Hydrochloride | Glyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-081 |
| Glyburide and Metformin Hydrochloride | Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-082 |
| Glyburide and Metformin Hydrochloride | Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4718 |
| Glyburide and Metformin Hydrochloride | Glyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-7180 |
| Glyburide and Metformin Hydrochloride | Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8341 |
| Glyburide and Metformin Hydrochloride | Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8634 |
| Glyburide and Metformin Hydrochloride | Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0967 |