NDC 42858-401

APTENSIO XR

(methylphenidate Hydrochloride)

APTENSIO XR is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Rhodes Pharmaceuticals L.p.. The primary component is Methylphenidate Hydrochloride.

• Product ID: 42858-401_9468380f-2590-4c7a-9451-81776fa2cfaf
• NDC: 42858-401
• Product Type: Human Prescription Drug
• Proprietary Name: APTENSIO XR
• Generic Name: (methylphenidate Hydrochloride)
• Dosage Form: Capsule, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2015-04-17
• Marketing Category: NDA / NDA
• Application Number: NDA205831
• Labeler Name: Rhodes Pharmaceuticals L.P.
• Substance Name: METHYLPHENIDATE HYDROCHLORIDE
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 42858-401-45

90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-401-45)

• Marketing Start Date: 2015-04-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42858-401-45 [42858040145]

APTENSIO XR CAPSULE, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA205831
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-04-17

Drug Details

Active Ingredients

Ingredient	Strength
METHYLPHENIDATE HYDROCHLORIDE	10 mg/1

OpenFDA Data

• SPL SET ID: 5adedc01-ebf0-11e3-ac10-0800200c9a66
• Manufacturer:
  • Rhodes Pharmaceuticals L.P.
• UNII:
  • 4B3SC438HI
• RxNorm Concept Unique ID - RxCUI:
  • 1648185
  • 1648192
  • 1806200
  • 1806204
  • 1648180
  • 1648183
  • 1648195
  • 1648198
  • 1648189
  • 1806202
  • 1648201
  • 1806206
  • 1806208
  • 1806210

Pharmacological Class

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

NDC Crossover Matching brand name "APTENSIO XR" or generic name "(methylphenidate Hydrochloride)"

NDC	Brand Name	Generic Name
42858-401	APTENSIO XR	(methylphenidate hydrochloride)
42858-402	APTENSIO XR	(methylphenidate hydrochloride)
42858-403	APTENSIO XR	(methylphenidate hydrochloride)
42858-404	APTENSIO XR	(methylphenidate hydrochloride)
42858-405	APTENSIO XR	(methylphenidate hydrochloride)
42858-406	APTENSIO XR	(methylphenidate hydrochloride)
42858-407	APTENSIO XR	(methylphenidate hydrochloride)