FDA.reportPublic FDA data

JORNAY PM

Product NDC
71376-204
11-digit product format
713760204
Labeler code
71376
Product ID
71376-204_1c0e3d41-30b4-4815-8dbc-5466eaf56f8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Ironshore Pharmaceuticals Inc.
Application
NDA209311
Marketing category
NDA
Marketing start
2019-06-01
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
80 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
JORNAY PM
Brand name suffix
Extended-Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B3SC438HI
Rxcui2168857, 2168859, 2168861, 2168863, 2168864, 2168865, 2168866, 2168867, 2168868, 2168869

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
143536be-f21a-464c-bc5a-163f5c171815Product name220250626
fd4d0878-dcea-3832-288e-e3bbbbe580ffProduct name920240516
435f0341-cf24-41d5-8fbf-c909821e5596Product name120230313
c9b6eabb-08d7-bb2d-e81a-06be3590b436Product name220221216
67aa32c6-44f4-50de-64dd-643e8caf420dProduct name620210622
50b24f34-96fa-4f1e-b262-b0baf4a4a440Product name420210513
cf83c421-eebe-4de2-b1a2-fd96e3dbfcf8Product name120200128
166d1d2d-dd55-4fdf-82e2-b83a3c5347c1Product name120190828
343a61d5-785d-cc27-a43a-0779da054d88Product name320190828
7607489b-cd15-3103-f3b1-d4283574d250Product name220190614
407f0cce-da29-4050-a512-2cabe9e5692dProduct name920190611
f7f4bf1e-7c67-46c6-8c42-9beb1a06b38eProduct name220190415
190572d9-6c7b-4b40-8172-c1b5f802c20fProduct name120180724
2948856e-f76e-d380-d9ed-b317efafbc98Product name520180423
c0aa09de-7aa1-4a98-8f70-62ec3c97c695Product name120170803
3317aade-2d6e-f159-9fe6-e8385a825178Product name320160829
0fe52203-83a7-4fed-a91f-8e47a22cf1d3Product name120160111

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71376-204-032024-08-23C16284748780-11030e365-2873-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use JORNAY PM® safely and effectively. See full prescribing information for JORNAY PM. JORNAY PM (methylphenidate hydrochloride) extended-release capsules, for oral use, CII Initial U.S. Approval: 1955
71376-204-032024-08-23C16284748780-11030e365-2873-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use JORNAY PM® safely and effectively. See full prescribing information for JORNAY PM. JORNAY PM (methylphenidate hydrochloride) extended-release capsules, for oral use, CII Initial U.S. Approval: 1955
71376-204-032024-07-30C16284748780-11030e365-2873-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use JORNAY PM® safely and effectively. See full prescribing information for JORNAY PM. JORNAY PM (methylphenidate hydrochloride) extended-release capsules, for oral use, CII Initial U.S. Approval: 1955
71376-204-032024-07-30C16284748780-11030e365-2873-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use JORNAY PM® safely and effectively. See full prescribing information for JORNAY PM. JORNAY PM (methylphenidate hydrochloride) extended-release capsules, for oral use, CII Initial U.S. Approval: 1955
71376-204-032024-01-30C16284748780-11030e365-2873-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use JORNAY PM® safely and effectively. See full prescribing information for JORNAY PM. JORNAY PM (methylphenidate hydrochloride) extended-release capsules, for oral use, CII Initial U.S. Approval: 1955
71376-204-032024-01-30C16284748780-11030e365-2873-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use JORNAY PM® safely and effectively. See full prescribing information for JORNAY PM. JORNAY PM (methylphenidate hydrochloride) extended-release capsules, for oral use, CII Initial U.S. Approval: 1955

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71376-204-03JORNAY PM Extended-Release100 in 1 BOTTLECAPSULE10016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71376-204-03EA - Each71376-2044cfa8a13-9339-4d32-bd9f-bacfffebaf8d12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71376-204JORNAY PM EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [IRONSHORE PHARMACEUTICALS INC.]15Current NDC, Legacy NDC, 1 package rows20240824_d95dede0-b1ff-4489-8f91-3bbe122852bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2168865JORNAY PM 100 MG 24HR Extended Release Oral CapsulePSNd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168867JORNAY PM 20 MG 24HR Extended Release Oral CapsulePSNd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168869JORNAY PM 40 MG 24HR Extended Release Oral CapsulePSNd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168859JORNAY PM 60 MG 24HR Extended Release Oral CapsulePSNd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168863JORNAY PM 80 MG 24HR Extended Release Oral CapsulePSNd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168864methylphenidate HCl 100 MG 24HR Extended Release Oral Capsule, Evening DosingPSNd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168866methylphenidate HCl 20 MG 24HR Extended Release Oral Capsule, Evening DosingPSNd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168868methylphenidate HCl 40 MG 24HR Extended Release Oral Capsule, Evening DosingPSNd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168857methylphenidate HCl 60 MG 24HR Extended Release Oral Capsule, Evening DosingPSNd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168861methylphenidate HCl 80 MG 24HR Extended Release Oral Capsule, Evening DosingPSNd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168865Evening Dosing 24 HR methylphenidate hydrochloride 100 MG Extended Release Oral Capsule [Jornay]SBDd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168867Evening Dosing 24 HR methylphenidate hydrochloride 20 MG Extended Release Oral Capsule [Jornay]SBDd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168869Evening Dosing 24 HR methylphenidate hydrochloride 40 MG Extended Release Oral Capsule [Jornay]SBDd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168859Evening Dosing 24 HR methylphenidate hydrochloride 60 MG Extended Release Oral Capsule [Jornay]SBDd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168863Evening Dosing 24 HR methylphenidate hydrochloride 80 MG Extended Release Oral Capsule [Jornay]SBDd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168864Evening Dosing 24 HR methylphenidate hydrochloride 100 MG Extended Release Oral CapsuleSCDd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168866Evening Dosing 24 HR methylphenidate hydrochloride 20 MG Extended Release Oral CapsuleSCDd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168868Evening Dosing 24 HR methylphenidate hydrochloride 40 MG Extended Release Oral CapsuleSCDd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168857Evening Dosing 24 HR methylphenidate hydrochloride 60 MG Extended Release Oral CapsuleSCDd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168861Evening Dosing 24 HR methylphenidate hydrochloride 80 MG Extended Release Oral CapsuleSCDd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168865Evening Dosing 24 HR Jornay 100 MG Extended Release Oral CapsuleSYd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168867Evening Dosing 24 HR Jornay 20 MG Extended Release Oral CapsuleSYd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168869Evening Dosing 24 HR Jornay 40 MG Extended Release Oral CapsuleSYd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168859Evening Dosing 24 HR Jornay 60 MG Extended Release Oral CapsuleSYd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168863Evening Dosing 24 HR Jornay 80 MG Extended Release Oral CapsuleSYd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168865Jornay PM 100 MG 24HR Extended Release Oral CapsuleSYd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168867Jornay PM 20 MG 24HR Extended Release Oral CapsuleSYd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168869Jornay PM 40 MG 24HR Extended Release Oral CapsuleSYd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168859Jornay PM 60 MG 24HR Extended Release Oral CapsuleSYd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168863Jornay PM 80 MG 24HR Extended Release Oral CapsuleSYd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168864methylphenidate HCl 100 MG 24HR Extended Release Oral Capsule, Evening DosingSYd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168866methylphenidate HCl 20 MG 24HR Extended Release Oral Capsule, Evening DosingSYd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168868methylphenidate HCl 40 MG 24HR Extended Release Oral Capsule, Evening DosingSYd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168857methylphenidate HCl 60 MG 24HR Extended Release Oral Capsule, Evening DosingSYd95dede0-b1ff-4489-8f91-3bbe122852bf16
2168861methylphenidate HCl 80 MG 24HR Extended Release Oral Capsule, Evening DosingSYd95dede0-b1ff-4489-8f91-3bbe122852bf16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71376-204-0371376020403100 CAPSULE in 1 BOTTLE (71376-204-03) 100 capsule2019-06-010000-00-00NoNoCurrent