NDC 68788-9091

Tizanidine

Tizanidine

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

• Product ID: 68788-9091_f6e7c4af-3900-4c54-bfff-662cd4da075a
• NDC: 68788-9091
• Product Type: Human Prescription Drug
• Proprietary Name: Tizanidine
• Generic Name: Tizanidine
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2002-07-03
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076286
• Labeler Name: Preferred Pharmaceuticals, Inc
• Substance Name: TIZANIDINE HYDROCHLORIDE
• Active Ingredient Strength: 2 mg/1
• Pharm Classes: Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 68788-9091-3

30 TABLET in 1 BOTTLE, DISPENSING (68788-9091-3)

• Marketing Start Date: 2011-08-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68788-9091-9 [68788909109]

Tizanidine TABLET

• Marketing Category: ANDA
• Application Number: ANDA076286
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-08-12
• Marketing End Date: 2019-11-13

NDC 68788-9091-2 [68788909102]

Tizanidine TABLET

• Marketing Category: ANDA
• Application Number: ANDA076286
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-09-20
• Marketing End Date: 2019-11-13

NDC 68788-9091-3 [68788909103]

Tizanidine TABLET

• Marketing Category: ANDA
• Application Number: ANDA076286
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-08-12
• Marketing End Date: 2019-11-13

NDC 68788-9091-8 [68788909108]

Tizanidine TABLET

• Marketing Category: ANDA
• Application Number: ANDA076286
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-08-12
• Marketing End Date: 2019-11-13

NDC 68788-9091-6 [68788909106]

Tizanidine TABLET

• Marketing Category: ANDA
• Application Number: ANDA076286
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-08-12
• Marketing End Date: 2019-11-13

Drug Details

Active Ingredients

Ingredient	Strength
TIZANIDINE HYDROCHLORIDE	2 mg/1

OpenFDA Data

• SPL SET ID: fce6f784-cfc5-49ef-af1f-fa6dc389ed3e
• Manufacturer:
  • Preferred Pharmaceuticals, Inc
• UNII:
  • B53E3NMY5C
• RxNorm Concept Unique ID - RxCUI:
  • 313412
  • 313413

Pharmacological Class

• Adrenergic alpha2-Agonists [MoA]
• Central alpha-2 Adrenergic Agonist [EPC]

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

NDC	Brand Name	Generic Name
0378-0722	Tizanidine	tizanidine
0378-0724	Tizanidine	tizanidine
0615-5574	Tizanidine	Tizanidine
0615-6564	Tizanidine	Tizanidine
0615-7996	Tizanidine	Tizanidine
0615-8274	Tizanidine	Tizanidine
0615-8360	Tizanidine	Tizanidine
0904-6418	tizanidine	tizanidine
0904-6898	Tizanidine	Tizanidine
10544-576	tizanidine	tizanidine
10544-587	tizanidine	tizanidine
10544-863	tizanidine	tizanidine
10544-890	Tizanidine	Tizanidine
16714-171	Tizanidine	Tizanidine
16714-172	Tizanidine	Tizanidine
29300-168	Tizanidine	Tizanidine
29300-169	Tizanidine	Tizanidine
33261-103	Tizanidine	Tizanidine
33261-104	Tizanidine	Tizanidine
35356-662	Tizanidine	Tizanidine
42291-808	Tizanidine	Tizanidine
42291-809	Tizanidine	Tizanidine
43063-455	Tizanidine	Tizanidine
43063-868	Tizanidine	Tizanidine
67877-614	Tizanidine	Tizanidine
67877-613	Tizanidine	Tizanidine
68071-3288	tizanidine	tizanidine
68071-4463	Tizanidine	Tizanidine
68084-645	Tizanidine	Tizanidine
68084-775	Tizanidine	Tizanidine
68788-6365	Tizanidine	Tizanidine
68788-6444	Tizanidine	Tizanidine
68788-9514	tizanidine	tizanidine
68788-9091	Tizanidine	Tizanidine
68788-9092	Tizanidine	Tizanidine
68788-9497	tizanidine	tizanidine
69420-1506	Tizanidine	Tizanidine
69420-1504	Tizanidine	Tizanidine
69420-1502	Tizanidine	Tizanidine
70518-0133	Tizanidine	Tizanidine
70518-0774	tizanidine	tizanidine
70518-0573	Tizanidine	Tizanidine
70518-1598	Tizanidine	Tizanidine
70518-1439	Tizanidine	Tizanidine
70710-1104	tizanidine	tizanidine
70771-1336	tizanidine	tizanidine
70710-1105	tizanidine	tizanidine
70771-1335	tizanidine	tizanidine
71335-0424	Tizanidine	Tizanidine
71335-0914	Tizanidine	Tizanidine