NDC 68788-6436

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	68788-6436_08cc0a22-504a-4a20-8a50-f834ff0a15e3
NDC	68788-6436
Product Type	Human Prescription Drug
Proprietary Name	Glimepiride
Generic Name	Glimepiride
Dosage Form	Tablet
Route of Administration	ORAL
Marketing Start Date	2016-07-11
Marketing Category	ANDA / ANDA
Application Number	ANDA078181
Labeler Name	Preferred Pharmaceuticals Inc.
Substance Name	GLIMEPIRIDE
Active Ingredient Strength	4 mg/1
Pharm Classes	Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC Exclude Flag	N
Listing Certified Through	2019-12-31

Packaging

NDC 68788-6436-6

60 TABLET in 1 BOTTLE (68788-6436-6)

Marketing Start Date	2016-07-11
NDC Exclude Flag	N
Sample Package?	N

NDC SPL Data Element Entries

NDC 68788-6436-9 [68788643609]

Glimepiride TABLET

Marketing Category	ANDA
Application Number	ANDA078181
Product Type	HUMAN PRESCRIPTION DRUG
Billing Unit	EA
Marketing Start Date	2016-07-11
Inactivation Date	2020-01-31

NDC 68788-6436-6 [68788643606]

Glimepiride TABLET

Marketing Category	ANDA
Application Number	ANDA078181
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2016-07-11
Inactivation Date	2020-01-31

NDC 68788-6436-1 [68788643601]

Glimepiride TABLET

Marketing Category	ANDA
Application Number	ANDA078181
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2016-07-11
Inactivation Date	2020-01-31

NDC 68788-6436-3 [68788643603]

Glimepiride TABLET

Marketing Category	ANDA
Application Number	ANDA078181
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2016-07-11
Inactivation Date	2020-01-31

NDC 68788-6436-7 [68788643607]

Glimepiride TABLET

Marketing Category	ANDA
Application Number	ANDA078181
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2016-07-20
Inactivation Date	2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
GLIMEPIRIDE	4 mg/1

OpenFDA Data

SPL SET ID:	7206bc6c-516e-49cf-8382-153289e355fc
Manufacturer	Preferred Pharmaceuticals Inc.
UNII	6KY687524K
RxNorm Concept Unique ID - RxCUI	199247

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