FDA.reportPublic FDA data

METHYLPHENIDATE HYDROCHLORIDE

Product NDC
50268-529
11-digit product format
502680529
Labeler code
50268
Product ID
50268-529_47e73f94-511d-3879-e063-6394a90ab6af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHYLPHENIDATE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA207416
Marketing category
ANDA
Marketing start
2020-02-13
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
20 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 HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B3SC438HI
Rxcui1091150, 1091392

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
50268-529-11METHYLPHENIDATE HYDROCHLORIDE1 in 1 BLISTER PACKTABLET15
50268-529-15METHYLPHENIDATE HYDROCHLORIDE50 in 1 BOXTABLET505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-529-11EA - Each50268-5296e5445c0-e03e-4afd-a9e6-d86658b8197c12020-03-10
50268-529-15EA - Each50268-5292a586556-0f1d-4df7-963e-4bd7d62bb2b312020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-529METHYLPHENIDATE HYDROCHLORIDE TABLET [AVPAK]4Current NDC, Legacy NDC, 2 package rows20240110_9e7967c8-d323-160d-e053-2995a90a323e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091150methylphenidate HCl 10 MG Oral TabletPSN9e7967c8-d323-160d-e053-2995a90a323e5
1091392methylphenidate HCl 20 MG Oral TabletPSN9e7967c8-d323-160d-e053-2995a90a323e5
1091150methylphenidate hydrochloride 10 MG Oral TabletSCD9e7967c8-d323-160d-e053-2995a90a323e5
1091392methylphenidate hydrochloride 20 MG Oral TabletSCD9e7967c8-d323-160d-e053-2995a90a323e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-529-11502680529111 in 1 BLISTER PACKHistorical
50268-529-155026805291550 BLISTER PACK in 1 BOX (50268-529-15) / 1 TABLET in 1 BLISTER PACK (50268-529-11) 50 blister pack2020-02-130000-00-00NoNoCurrent