FDA.reportPublic FDA data

Methylphenidate Hydrochloride

Product NDC
0093-5348
11-digit product format
000935348
Labeler code
0093
Product ID
0093-5348_663ba889-95b5-45c2-af06-c90459d30d6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA079031
Marketing category
ANDA
Marketing start
2012-07-16
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
40 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
Brand name suffix
(LA)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B3SC438HI
Rxcui1806177, 1806179, 1806183

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
143536be-f21a-464c-bc5a-163f5c171815Product name220250626
fd4d0878-dcea-3832-288e-e3bbbbe580ffProduct name920240516
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
0093-5348-01Methylphenidate Hydrochloride(LA)100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-5348-01EA - Each0093-5348e3c85aa7-9574-4092-b075-c7f9c24f9ca112013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT4B3SC438HIMETHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]3
METHYLPHENIDATEACTIVE MOIETY207ZZ9QZ49METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]3
AMMONIO METHACRYLATE COPOLYMER TYPE BINACTIVE INGREDIENT161H3B14U2METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]3
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LMETHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMETHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMETHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMETHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMETHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]3
GELATININACTIVE INGREDIENT2G86QN327LMETHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]3
HYPROMELLOSE 2208 (3 MPA.S)INACTIVE INGREDIENT9H4L916OBUMETHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]3
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]3
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEMETHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]3
SHELLACINACTIVE INGREDIENT46N107B71OMETHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]3
SUCROSEINACTIVE INGREDIENTC151H8M554METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UMETHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]3
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMMETHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-5348METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA, INC.]10Current NDC, Legacy NDC, 1 package rows20211119_034fb7cd-e183-475e-8beb-64fd88facc8f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1806177methylphenidate HCl 20 MG 50/50 Release 24HR Extended Release Oral CapsulePSN034fb7cd-e183-475e-8beb-64fd88facc8f10
1806179methylphenidate HCl 30 MG 50/50 Release 24HR Extended Release Oral CapsulePSN034fb7cd-e183-475e-8beb-64fd88facc8f10
1806183methylphenidate HCl 40 MG 50/50 Release 24HR Extended Release Oral CapsulePSN034fb7cd-e183-475e-8beb-64fd88facc8f10
180617750/50 Release 24 HR methylphenidate hydrochloride 20 MG Extended Release Oral CapsuleSCD034fb7cd-e183-475e-8beb-64fd88facc8f10
180617950/50 Release 24 HR methylphenidate hydrochloride 30 MG Extended Release Oral CapsuleSCD034fb7cd-e183-475e-8beb-64fd88facc8f10
180618350/50 Release 24 HR methylphenidate hydrochloride 40 MG Extended Release Oral CapsuleSCD034fb7cd-e183-475e-8beb-64fd88facc8f10
1806177methylphenidate HCl 20 MG 50/50 Release 24HR Extended Release Oral CapsuleSY034fb7cd-e183-475e-8beb-64fd88facc8f10
1806179methylphenidate HCl 30 MG 50/50 Release 24HR Extended Release Oral CapsuleSY034fb7cd-e183-475e-8beb-64fd88facc8f10
1806183methylphenidate HCl 40 MG 50/50 Release 24HR Extended Release Oral CapsuleSY034fb7cd-e183-475e-8beb-64fd88facc8f10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-5348-0100093534801100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5348-01) 2012-07-160000-00-00NoNoCurrent