FDA.reportPublic FDA data

METHYLPHENIDATE HYDROCHLORIDE

Product NDC
71335-1219
11-digit product format
713351219
Labeler code
71335
Product ID
71335-1219_6183e88c-f148-4ee3-a49c-6e7aee7009bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHYLPHENIDATE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207416
Marketing category
ANDA
Marketing start
2015-10-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
METHYLPHENIDATE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B3SC438HI
Rxcui1091392

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
71335-1219-1METHYLPHENIDATE HYDROCHLORIDE30 in 1 BOTTLETABLET304
71335-1219-2METHYLPHENIDATE HYDROCHLORIDE100 in 1 BOTTLETABLET1004
71335-1219-3METHYLPHENIDATE HYDROCHLORIDE90 in 1 BOTTLETABLET904
71335-1219-4METHYLPHENIDATE HYDROCHLORIDE60 in 1 BOTTLETABLET604
71335-1219-5METHYLPHENIDATE HYDROCHLORIDE120 in 1 BOTTLETABLET1204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1219-2EA - Each71335-1219a7c084fb-8cdf-47e9-84de-3b8017d3def812020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1219METHYLPHENIDATE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 5 package rows20241116_ec3d9304-13bc-4f0b-bf14-1a1ea824bd91.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091392methylphenidate HCl 20 MG Oral TabletPSNec3d9304-13bc-4f0b-bf14-1a1ea824bd914
1091392methylphenidate hydrochloride 20 MG Oral TabletSCDec3d9304-13bc-4f0b-bf14-1a1ea824bd914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1219-17133512190130 TABLET in 1 BOTTLE (71335-1219-1) 30 tablet2024-10-310000-00-00NoNoCurrent
71335-1219-271335121902100 TABLET in 1 BOTTLE (71335-1219-2) 100 tablet2024-10-310000-00-00NoNoCurrent
71335-1219-37133512190390 TABLET in 1 BOTTLE (71335-1219-3) 90 tablet2019-04-240000-00-00NoNoCurrent
71335-1219-47133512190460 TABLET in 1 BOTTLE (71335-1219-4) 60 tablet2019-04-240000-00-00NoNoCurrent
71335-1219-571335121905120 TABLET in 1 BOTTLE (71335-1219-5) 120 tablet2024-10-310000-00-00NoNoCurrent