FDA.reportPublic FDA data

methylphenidate hydrochloride

Product NDC
0591-3862
11-digit product format
005913862
Labeler code
0591
Product ID
0591-3862_1895894a-ed70-4f82-b512-6bc184ee806c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylphenidate hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA208861
Marketing category
ANDA
Marketing start
2020-09-30
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
15 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
methylphenidate hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B3SC438HI
Rxcui1648183, 1806200, 1806202, 1806204, 1806206, 1806208, 1806210

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-3862-19methylphenidate hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-3862METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]14Current NDC, Legacy NDC, 1 package rows20240518_ecbb4a30-21ac-42e1-b4e9-6c35344ffc45.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1806200methylphenidate HCl 10 MG 40/60 Release 24HR Extended Release Oral CapsulePSNecbb4a30-21ac-42e1-b4e9-6c35344ffc4516
1648183methylphenidate HCl 15 MG 40/60 Release 24HR Extended Release Oral CapsulePSNecbb4a30-21ac-42e1-b4e9-6c35344ffc4516
1806202methylphenidate HCl 20 MG 40/60 Release 24HR Extended Release Oral CapsulePSNecbb4a30-21ac-42e1-b4e9-6c35344ffc4516
1806206methylphenidate HCl 30 MG 40/60 Release 24HR Extended Release Oral CapsulePSNecbb4a30-21ac-42e1-b4e9-6c35344ffc4516
1806210methylphenidate HCl 40 MG 40/60 Release 24HR Extended Release Oral CapsulePSNecbb4a30-21ac-42e1-b4e9-6c35344ffc4516
1806204methylphenidate HCl 50 MG 40/60 Release 24HR Extended Release Oral CapsulePSNecbb4a30-21ac-42e1-b4e9-6c35344ffc4516
1806208methylphenidate HCl 60 MG 40/60 Release 24HR Extended Release Oral CapsulePSNecbb4a30-21ac-42e1-b4e9-6c35344ffc4516
180620040/60 Release 24 HR methylphenidate hydrochloride 10 MG Extended Release Oral CapsuleSCDecbb4a30-21ac-42e1-b4e9-6c35344ffc4516
164818340/60 Release 24 HR methylphenidate hydrochloride 15 MG Extended Release Oral CapsuleSCDecbb4a30-21ac-42e1-b4e9-6c35344ffc4516
180620240/60 Release 24 HR methylphenidate hydrochloride 20 MG Extended Release Oral CapsuleSCDecbb4a30-21ac-42e1-b4e9-6c35344ffc4516
180620640/60 Release 24 HR methylphenidate hydrochloride 30 MG Extended Release Oral CapsuleSCDecbb4a30-21ac-42e1-b4e9-6c35344ffc4516
180621040/60 Release 24 HR methylphenidate hydrochloride 40 MG Extended Release Oral CapsuleSCDecbb4a30-21ac-42e1-b4e9-6c35344ffc4516
180620440/60 Release 24 HR methylphenidate hydrochloride 50 MG Extended Release Oral CapsuleSCDecbb4a30-21ac-42e1-b4e9-6c35344ffc4516
180620840/60 Release 24 HR methylphenidate hydrochloride 60 MG Extended Release Oral CapsuleSCDecbb4a30-21ac-42e1-b4e9-6c35344ffc4516
1806200methylphenidate HCl 10 MG 40/60 Release 24HR Extended Release Oral CapsuleSYecbb4a30-21ac-42e1-b4e9-6c35344ffc4516
1648183methylphenidate HCl 15 MG 40/60 Release 24HR Extended Release Oral CapsuleSYecbb4a30-21ac-42e1-b4e9-6c35344ffc4516
1806202methylphenidate HCl 20 MG 40/60 Release 24HR Extended Release Oral CapsuleSYecbb4a30-21ac-42e1-b4e9-6c35344ffc4516
1806206methylphenidate HCl 30 MG 40/60 Release 24HR Extended Release Oral CapsuleSYecbb4a30-21ac-42e1-b4e9-6c35344ffc4516
1806210methylphenidate HCl 40 MG 40/60 Release 24HR Extended Release Oral CapsuleSYecbb4a30-21ac-42e1-b4e9-6c35344ffc4516
1806204methylphenidate HCl 50 MG 40/60 Release 24HR Extended Release Oral CapsuleSYecbb4a30-21ac-42e1-b4e9-6c35344ffc4516
1806208methylphenidate HCl 60 MG 40/60 Release 24HR Extended Release Oral CapsuleSYecbb4a30-21ac-42e1-b4e9-6c35344ffc4516

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-3862-190059138621990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0591-3862-19) 2020-09-300000-00-00NoNoCurrent