Methylphenidate Hydrochloride

Product NDC
72162-2395
11-digit product format
721622395
Labeler code
72162
Product ID
72162-2395_6cdb2cd7-3d68-4e1b-bb74-c3bd808a28a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091695
Marketing category
ANDA
Marketing start
2013-07-10
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
27 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 HYDROCHLORIDE27 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B3SC438HI
Rxcui2001565

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
72162-2395-1Methylphenidate Hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE100102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2395METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]101Current NDC, 1 package rows20241124_5a29687b-5294-4b27-a556-514b092a877d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2001565methylphenidate HCl 27 MG 24HR Extended Release Oral Tablet, BX RatingPSN5a29687b-5294-4b27-a556-514b092a877d102
2001565BX Rating 24 HR methylphenidate hydrochloride 27 MG Extended Release Oral TabletSCD5a29687b-5294-4b27-a556-514b092a877d102
2001565methylphenidate HCl 27 MG 24HR Extended Release Oral Tablet, BX RatingSY5a29687b-5294-4b27-a556-514b092a877d102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2395-172162239501100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-2395-1) 2026-03-17NoNoHistorical