methylphenidate hydrochloride

Product NDC
0591-2715
11-digit product format
005912715
Labeler code
0591
Product ID
0591-2715_6b2dcacd-6280-421e-8ac2-ac00db79a5d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylphenidate hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
NDA021121
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2011-04-01
Marketing end
2021-09-30
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
18 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-2715-01EA - Each0591-2715adcb06b9-b226-43ce-b977-785b735207a712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT4B3SC438HIMETHYLPHENIDATE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
METHYLPHENIDATEACTIVE MOIETY207ZZ9QZ49METHYLPHENIDATE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KMETHYLPHENIDATE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZMETHYLPHENIDATE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6METHYLPHENIDATE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357METHYLPHENIDATE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETHYLPHENIDATE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GMETHYLPHENIDATE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNMETHYLPHENIDATE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMETHYLPHENIDATE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETHYLPHENIDATE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3METHYLPHENIDATE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMETHYLPHENIDATE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMETHYLPHENIDATE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
SUCCINIC ACIDINACTIVE INGREDIENTAB6MNQ6J6LMETHYLPHENIDATE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETHYLPHENIDATE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673METHYLPHENIDATE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091155methylphenidate HCl 18 MG 24HR Extended Release Oral TabletPSN2bfb390f-ba99-4d21-8a9e-50fa8ec217c01
1091170methylphenidate HCl 27 MG 24HR Extended Release Oral TabletPSN2bfb390f-ba99-4d21-8a9e-50fa8ec217c01
109115524 HR methylphenidate hydrochloride 18 MG Extended Release Oral TabletSCD2bfb390f-ba99-4d21-8a9e-50fa8ec217c01
109117024 HR methylphenidate hydrochloride 27 MG Extended Release Oral TabletSCD2bfb390f-ba99-4d21-8a9e-50fa8ec217c01
1091155methylphenidate hydrochloride 18 MG 24 HR Extended Release Oral TabletSY2bfb390f-ba99-4d21-8a9e-50fa8ec217c01
1091170methylphenidate hydrochloride 27 MG 24 HR Extended Release Oral TabletSY2bfb390f-ba99-4d21-8a9e-50fa8ec217c01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-2715-0100591271501100 TABLET in 1 BOTTLE (0591-2715-01) 100 tablet2011-04-012021-09-30NoNoCurrent