NDC 43386-860

Dexmethylphenidate Hydrochloride

Dexmethylphenidate Hydrochloride

Dexmethylphenidate Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Lupin Pharmaceuticals,inc.. The primary component is Dexmethylphenidate Hydrochloride.

• Product ID: 43386-860_6f1518ac-e7d3-4663-9a64-a134b5570a25
• NDC: 43386-860
• Product Type: Human Prescription Drug
• Proprietary Name: Dexmethylphenidate Hydrochloride
• Generic Name: Dexmethylphenidate Hydrochloride
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2015-12-04
• Marketing Category: ANDA / ANDA
• Application Number: ANDA204534
• Labeler Name: Lupin Pharmaceuticals,Inc.
• Substance Name: DEXMETHYLPHENIDATE HYDROCHLORIDE
• Active Ingredient Strength: 5 mg/1
• Pharm Classes: Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 43386-860-01

100 TABLET in 1 BOTTLE (43386-860-01)

• Marketing Start Date: 2015-12-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43386-860-10 [43386086010]

Dexmethylphenidate Hydrochloride TABLET

• Marketing Category: ANDA
• Application Number: ANDA204534
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-12-04

NDC 43386-860-01 [43386086001]

Dexmethylphenidate Hydrochloride TABLET

• Marketing Category: ANDA
• Application Number: ANDA204534
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-12-04

NDC 43386-860-03 [43386086003]

Dexmethylphenidate Hydrochloride TABLET

• Marketing Category: ANDA
• Application Number: ANDA204534
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-12-04

Drug Details

Active Ingredients

Ingredient	Strength
DEXMETHYLPHENIDATE HYDROCHLORIDE	5 mg/1

OpenFDA Data

• SPL SET ID: a61932ef-c2b6-4363-a21d-1f0358f317b6
• Manufacturer:
  • Lupin Pharmaceuticals,Inc.
• UNII:
  • 1678OK0E08
• RxNorm Concept Unique ID - RxCUI:
  • 899548
  • 899557
  • 899518
• UPC Code:
  • 0343386862030
  • 0343386861019
  • 0343386861101
  • 0343386862108
  • 0343386861033
  • 0343386860012
  • 0343386860036
  • 0343386862016

Pharmacological Class

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

Medicade Reported Pricing

43386086001 DEXMETHYLPHENIDATE 5 MG TAB

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Dexmethylphenidate Hydrochloride" or generic name "Dexmethylphenidate Hydrochloride"

NDC	Brand Name	Generic Name
0527-1899	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
0527-1901	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
0527-1900	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
0781-5689	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
0781-5676	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
0781-5691	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
10702-106	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
10702-108	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
10702-107	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
0093-5045	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
0093-5277	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
0093-5275	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
0093-5276	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
0093-5046	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
0093-5550	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
0093-5551	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
0093-5562	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
0093-5553	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
0093-5552	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
0093-5554	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
27808-092	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
27808-091	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
0115-1685	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride
27808-093	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
0115-1682	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride
0115-1684	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride
0115-1710	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride
0115-9918	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride
0115-9921	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride
0115-1683	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride
0115-1686	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride
0115-1709	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride
0115-9919	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride
0115-9920	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride
0115-9922	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride
42858-011	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE
42858-225	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE
42858-410	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE
43386-860	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
43386-861	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
43386-862	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
49884-539	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
49884-049	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
49884-248	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
49884-333	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
49884-339	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
49884-090	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
49884-048	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
49884-546	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride
57664-376	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride