NDC 70165-300

Cotempla XR-ODT

Methylphenidate

Cotempla XR-ODT is a Oral Tablet, Orally Disintegrating in the Human Prescription Drug category. It is labeled and distributed by Neos Therapeutics, Lp. The primary component is Methylphenidate.

• Product ID: 70165-300_7dec6513-60e0-42e3-890d-dedee031c696
• NDC: 70165-300
• Product Type: Human Prescription Drug
• Proprietary Name: Cotempla XR-ODT
• Generic Name: Methylphenidate
• Dosage Form: Tablet, Orally Disintegrating
• Route of Administration: ORAL
• Marketing Start Date: 2017-06-20
• Marketing Category: NDA / NDA
• Application Number: NDA205489
• Labeler Name: Neos Therapeutics, LP
• Substance Name: METHYLPHENIDATE
• Active Ingredient Strength: 26 mg/1
• Pharm Classes: Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 70165-300-30

5 BLISTER PACK in 1 CARTON (70165-300-30) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

• Marketing Start Date: 2017-06-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70165-300-30 [70165030030]

Cotempla XR-ODT TABLET, ORALLY DISINTEGRATING

• Marketing Category: NDA
• Application Number: NDA205489
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-06-20

Drug Details

Active Ingredients

Ingredient	Strength
METHYLPHENIDATE	25.9 mg/1

OpenFDA Data

• SPL SET ID: 33f70f58-c871-42c8-8adb-345caeafefcd
• Manufacturer:
  • Neos Therapeutics, LP
• UNII:
  • 207ZZ9QZ49
• RxNorm Concept Unique ID - RxCUI:
  • 1926849
  • 1926853
  • 1926847
  • 1926851
  • 1926840
  • 1926855

Pharmacological Class

• Central Nervous System Stimulant [EPC]
• Central Nervous System Stimulation [PE]

Medicade Reported Pricing

70165030030 COTEMPLA XR-ODT 25.9 MG TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Cotempla XR-ODT" or generic name "Methylphenidate"

NDC	Brand Name	Generic Name
70165-100	Cotempla XR-ODT	Methylphenidate
70165-200	Cotempla XR-ODT	Cotempla XR-ODT
70165-300	Cotempla XR-ODT	Cotempla XR-ODT
68968-5552	Daytrana	methylphenidate
68968-5553	Daytrana	methylphenidate
68968-5554	Daytrana	methylphenidate
68968-5555	Daytrana	methylphenidate
0378-8260	Methylphenidate	Methylphenidate
0378-8261	Methylphenidate	Methylphenidate
0378-8262	Methylphenidate	Methylphenidate
0378-8263	Methylphenidate	Methylphenidate
0781-2361	Methylphenidate	methylphenidate
0781-2362	Methylphenidate	methylphenidate
0781-2363	Methylphenidate	methylphenidate
0781-2364	Methylphenidate	methylphenidate