FDA.reportPublic FDA data

Methylphenidate Hydrochloride

Product NDC
62175-312
11-digit product format
621750312
Labeler code
62175
Product ID
62175-312_8b133cd2-e3c6-4742-b402-2393b56ffc93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA091695
Marketing category
ANDA
Marketing start
2013-09-23
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
36 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Methylphenidate Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE36 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B3SC438HI
Rxcui2001564, 2001565, 2001566, 2001568

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
143536be-f21a-464c-bc5a-163f5c171815Product name220250626
fd4d0878-dcea-3832-288e-e3bbbbe580ffProduct name920240516
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
f7f4bf1e-7c67-46c6-8c42-9beb1a06b38eProduct name220190415
190572d9-6c7b-4b40-8172-c1b5f802c20fProduct name120180724
2948856e-f76e-d380-d9ed-b317efafbc98Product name520180423
c0aa09de-7aa1-4a98-8f70-62ec3c97c695Product name120170803
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
3317aade-2d6e-f159-9fe6-e8385a825178Product name320160829
0fe52203-83a7-4fed-a91f-8e47a22cf1d3Product name120160111
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62175-312-37Methylphenidate Hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE10032

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62175-312-37EA - Each62175-312b8577a03-c354-4ec9-a0fb-46bd5206b1fb12013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT4B3SC438HIMETHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]17
METHYLPHENIDATEACTIVE MOIETY207ZZ9QZ49METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]17
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 400 MPA.S AT 1%)INACTIVE INGREDIENTFC40A8XAJ3METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]17
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]17
ETHYLCELLULOSE (10 MPA.S)INACTIVE INGREDIENT3DYK7UYZ62METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]17
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]17
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMETHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]17
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]17
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMETHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]17
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)INACTIVE INGREDIENT6N003M473WMETHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]17
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]17
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]17
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PMETHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]17
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]17
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]17
SUCROSEINACTIVE INGREDIENTC151H8M554METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]17
TALCINACTIVE INGREDIENT7SEV7J4R1UMETHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]17
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]17
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMMETHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62175-312METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [LANNETT COMPANY, INC.]28Current NDC, Legacy NDC, 1 package rows20241025_3d1f5aff-5d39-496c-b5ed-7f3c70ec641c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2001566methylphenidate HCl 36 MG 24HR Extended Release Oral Tablet, BX RatingPSNcd2c1226-fa19-4734-b62d-89fea73dcb0d102
2001566BX Rating 24 HR methylphenidate hydrochloride 36 MG Extended Release Oral TabletSCDcd2c1226-fa19-4734-b62d-89fea73dcb0d102
2001566methylphenidate HCl 36 MG 24HR Extended Release Oral Tablet, BX RatingSYcd2c1226-fa19-4734-b62d-89fea73dcb0d102
2001564methylphenidate HCl 18 MG 24HR Extended Release Oral Tablet, BX RatingPSN3d1f5aff-5d39-496c-b5ed-7f3c70ec641c32
2001565methylphenidate HCl 27 MG 24HR Extended Release Oral Tablet, BX RatingPSN3d1f5aff-5d39-496c-b5ed-7f3c70ec641c32
2001566methylphenidate HCl 36 MG 24HR Extended Release Oral Tablet, BX RatingPSN3d1f5aff-5d39-496c-b5ed-7f3c70ec641c32
2001568methylphenidate HCl 54 MG 24HR Extended Release Oral Tablet, BX RatingPSN3d1f5aff-5d39-496c-b5ed-7f3c70ec641c32
2001564BX Rating 24 HR methylphenidate hydrochloride 18 MG Extended Release Oral TabletSCD3d1f5aff-5d39-496c-b5ed-7f3c70ec641c32
2001565BX Rating 24 HR methylphenidate hydrochloride 27 MG Extended Release Oral TabletSCD3d1f5aff-5d39-496c-b5ed-7f3c70ec641c32
2001566BX Rating 24 HR methylphenidate hydrochloride 36 MG Extended Release Oral TabletSCD3d1f5aff-5d39-496c-b5ed-7f3c70ec641c32
2001568BX Rating 24 HR methylphenidate hydrochloride 54 MG Extended Release Oral TabletSCD3d1f5aff-5d39-496c-b5ed-7f3c70ec641c32
2001564methylphenidate HCl 18 MG 24HR Extended Release Oral Tablet, BX RatingSY3d1f5aff-5d39-496c-b5ed-7f3c70ec641c32
2001565methylphenidate HCl 27 MG 24HR Extended Release Oral Tablet, BX RatingSY3d1f5aff-5d39-496c-b5ed-7f3c70ec641c32
2001566methylphenidate HCl 36 MG 24HR Extended Release Oral Tablet, BX RatingSY3d1f5aff-5d39-496c-b5ed-7f3c70ec641c32
2001568methylphenidate HCl 54 MG 24HR Extended Release Oral Tablet, BX RatingSY3d1f5aff-5d39-496c-b5ed-7f3c70ec641c32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62175-312-3762175031237100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62175-312-37) 2013-09-230000-00-00NoNoCurrent