NDC 68788-6411

Glimepiride

Glimepiride

Glimepiride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Preferred Pharmaceuticals Inc.. The primary component is Glimepiride.

• Product ID: 68788-6411_72aab9d9-2467-43d4-baa5-b788c0e07148
• NDC: 68788-6411
• Product Type: Human Prescription Drug
• Proprietary Name: Glimepiride
• Generic Name: Glimepiride
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2016-06-10
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078181
• Labeler Name: Preferred Pharmaceuticals Inc.
• Substance Name: GLIMEPIRIDE
• Active Ingredient Strength: 2 mg/1
• Pharm Classes: Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 68788-6411-1

100 TABLET in 1 BOTTLE (68788-6411-1)

• Marketing Start Date: 2016-06-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68788-6411-1 [68788641101]

Glimepiride TABLET

• Marketing Category: ANDA
• Application Number: ANDA078181
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-06-10

NDC 68788-6411-3 [68788641103]

Glimepiride TABLET

• Marketing Category: ANDA
• Application Number: ANDA078181
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-06-10

NDC 68788-6411-9 [68788641109]

Glimepiride TABLET

• Marketing Category: ANDA
• Application Number: ANDA078181
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-06-10

NDC 68788-6411-6 [68788641106]

Glimepiride TABLET

• Marketing Category: ANDA
• Application Number: ANDA078181
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-06-10

Drug Details

Active Ingredients

Ingredient	Strength
GLIMEPIRIDE	2 mg/1

OpenFDA Data

• SPL SET ID: fc5f6f59-881b-4bf9-9ec1-2f804cbdb1fc
• Manufacturer:
  • Preferred Pharmaceuticals Inc.
• UNII:
  • 6KY687524K
• RxNorm Concept Unique ID - RxCUI:
  • 199246

Pharmacological Class

• Sulfonylurea [EPC]
• Sulfonylurea Compounds [CS]

NDC Crossover Matching brand name "Glimepiride" or generic name "Glimepiride"

NDC	Brand Name	Generic Name
0093-7254	Glimepiride	Glimepiride
0093-7255	Glimepiride	Glimepiride
0093-7256	Glimepiride	Glimepiride
0378-4011	Glimepiride	glimepiride
0378-4012	Glimepiride	glimepiride
0378-4013	Glimepiride	glimepiride
0440-6564	Glimepiride	Glimepiride
0440-6565	Glimepiride	Glimepiride
0440-6566	Glimepiride	Glimepiride
0615-6575	Glimepiride	Glimepiride
0615-6576	Glimepiride	Glimepiride
0615-7523	Glimepiride	Glimepiride
0615-8332	Glimepiride	Glimepiride
0615-8333	Glimepiride	Glimepiride
0615-8334	Glimepiride	Glimepiride
10544-217	Glimepiride	Glimepiride
10544-219	Glimepiride	Glimepiride
16571-773	Glimepiride	Glimepiride
16571-774	Glimepiride	Glimepiride
16571-775	Glimepiride	Glimepiride
16729-001	Glimepiride	Glimepiride
16729-002	Glimepiride	Glimepiride
16729-003	Glimepiride	Glimepiride
21695-746	Glimepiride	Glimepiride
21695-747	Glimepiride	Glimepiride
21695-993	Glimepiride	Glimepiride
33261-831	Glimepiride	Glimepiride
33261-892	Glimepiride	Glimepiride
33261-961	Glimepiride	Glimepiride
35356-896	Glimepiride	Glimepiride
42571-100	Glimepiride	Glimepiride
68001-179	Glimepiride	Glimepiride
68001-177	Glimepiride	Glimepiride
68001-178	Glimepiride	Glimepiride
68071-1942	Glimepiride	Glimepiride
68071-1910	Glimepiride	Glimepiride
68071-3024	Glimepiride	Glimepiride
68071-1991	Glimepiride	Glimepiride
68071-3068	Glimepiride	Glimepiride
68071-3239	Glimepiride	Glimepiride
68084-327	Glimepiride	Glimepiride
68084-326	Glimepiride	Glimepiride
68084-788	Glimepiride	Glimepiride
68645-572	Glimepiride	Glimepiride
68645-573	Glimepiride	Glimepiride
68788-6801	Glimepiride	Glimepiride
68788-6818	Glimepiride	Glimepiride
68788-6436	Glimepiride	Glimepiride
68788-6411	Glimepiride	Glimepiride
69452-129	Glimepiride	Glimepiride