aptensio xr

Generic: methylphenidate hydrochloride

Labeler: rhodes pharmaceuticals l.p.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name aptensio xr
Generic Name methylphenidate hydrochloride
Labeler rhodes pharmaceuticals l.p.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 40 mg/1

Manufacturer
Rhodes Pharmaceuticals L.P.

Identifiers & Regulatory

Product NDC 42858-405
Product ID 42858-405_0a491e4a-bf25-46f7-abce-58c2dfa8f30c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205831
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2015-04-17

Pharmacologic Class

Classes
central nervous system stimulant [epc] central nervous system stimulation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42858405
Hyphenated Format 42858-405

Supplemental Identifiers

RxCUI
1648180 1648183 1648185 1648189 1648192 1648195 1648198 1648201 1806200 1806202 1806204 1806206 1806208 1806210
UPC
0342858404457 0342858403450 0342858402453 0342858401456
UNII
4B3SC438HI

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name aptensio xr (source: ndc)
Generic Name methylphenidate hydrochloride (source: ndc)
Application Number NDA205831 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-405-45)
source: ndc

Packages (1)

42858-405-45 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-405-45)

Ingredients (1)

methylphenidate hydrochloride (40 mg/1)

Linked Drug Pages (1)

APTENSIO XR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0a491e4a-bf25-46f7-abce-58c2dfa8f30c", "openfda": {"upc": ["0342858404457", "0342858403450", "0342858402453", "0342858401456"], "unii": ["4B3SC438HI"], "rxcui": ["1648180", "1648183", "1648185", "1648189", "1648192", "1648195", "1648198", "1648201", "1806200", "1806202", "1806204", "1806206", "1806208", "1806210"], "spl_set_id": ["5adedc01-ebf0-11e3-ac10-0800200c9a66"], "manufacturer_name": ["Rhodes Pharmaceuticals L.P."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-405-45)", "package_ndc": "42858-405-45", "marketing_start_date": "20150417"}], "brand_name": "APTENSIO XR", "product_id": "42858-405_0a491e4a-bf25-46f7-abce-58c2dfa8f30c", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "42858-405", "dea_schedule": "CII", "generic_name": "methylphenidate hydrochloride", "labeler_name": "Rhodes Pharmaceuticals L.P.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "APTENSIO XR", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "NDA205831", "marketing_category": "NDA", "marketing_start_date": "20150417", "listing_expiration_date": "20261231"}