jornay pm extended-release

Generic: methylphenidate hydrochloride

Labeler: ironshore pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name jornay pm extended-release
Generic Name methylphenidate hydrochloride
Labeler ironshore pharmaceuticals inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 100 mg/1

Manufacturer
Ironshore Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71376-205
Product ID 71376-205_1c0e3d41-30b4-4815-8dbc-5466eaf56f8f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209311
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2019-06-01

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 71376205
Hyphenated Format 71376-205

Supplemental Identifiers

RxCUI
2168857 2168859 2168861 2168863 2168864 2168865 2168866 2168867 2168868 2168869
UPC
0371376202030 0371376204034 0371376205031 0371376201033 0371376203037
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 jornay pm extended-release (source: ndc)
Generic Name methylphenidate hydrochloride (source: ndc)
Application Number NDA209311 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (71376-205-03)
source: ndc

Packages (1)

71376-205-03 100 CAPSULE in 1 BOTTLE (71376-205-03)

Ingredients (1)

methylphenidate hydrochloride (100 mg/1)

Linked Drug Pages (1)

JORNAY PM Extended-Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1c0e3d41-30b4-4815-8dbc-5466eaf56f8f", "openfda": {"upc": ["0371376202030", "0371376204034", "0371376205031", "0371376201033", "0371376203037"], "unii": ["4B3SC438HI"], "rxcui": ["2168857", "2168859", "2168861", "2168863", "2168864", "2168865", "2168866", "2168867", "2168868", "2168869"], "spl_set_id": ["d95dede0-b1ff-4489-8f91-3bbe122852bf"], "manufacturer_name": ["Ironshore Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (71376-205-03)", "package_ndc": "71376-205-03", "marketing_start_date": "20190601"}], "brand_name": "JORNAY PM Extended-Release", "product_id": "71376-205_1c0e3d41-30b4-4815-8dbc-5466eaf56f8f", "dosage_form": "CAPSULE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "71376-205", "dea_schedule": "CII", "generic_name": "Methylphenidate Hydrochloride", "labeler_name": "Ironshore Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "JORNAY PM", "brand_name_suffix": "Extended-Release", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "NDA209311", "marketing_category": "NDA", "marketing_start_date": "20190601", "listing_expiration_date": "20261231"}