FDA.reportPublic FDA data

Methylphenidate Hydrochloride

Product NDC
71930-024
11-digit product format
719300024
Labeler code
71930
Product ID
71930-024_2ec047c6-e9ea-4093-bb03-1b3f80fb2a13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Eywa Pharma Inc
Application
ANDA210139
Marketing category
ANDA
Marketing start
2019-03-29
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
5 mg/5mL
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 HYDROCHLORIDE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B3SC438HI
Rxcui1091133, 1091341

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
71930-024-52Methylphenidate Hydrochloride500 mL in 1 BOTTLESOLUTION5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71930-024-52ML - Milliliter71930-02480134538-7f47-41f5-8f13-26a4e6d7542d12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71930-024METHYLPHENIDATE HYDROCHLORIDE SOLUTION [EYWA PHARMA INC]6Current NDC, Legacy NDC, 1 package rows20231111_298fb86d-7d94-49e1-b743-3e7801122422.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091341methylphenidate HCl 5 MG in 5 mL Oral SolutionPSNea5a6d4e-60ba-46f3-b314-3c7a970b377d102
1091341methylphenidate hydrochloride 1 MG/ML Oral SolutionSCDea5a6d4e-60ba-46f3-b314-3c7a970b377d102
1091341methylphenidate HCl 10 MG per 10 ML Oral SolutionSYea5a6d4e-60ba-46f3-b314-3c7a970b377d102
1091341methylphenidate HCl 5 MG per 5 ML Oral SolutionSYea5a6d4e-60ba-46f3-b314-3c7a970b377d102
1091341methylphenidate hydrochloride 5 MG per 5 ML Oral SolutionSYea5a6d4e-60ba-46f3-b314-3c7a970b377d102
1091341methylphenidate HCl 5 MG in 5 mL Oral SolutionPSNb9c31526-d486-433c-9b3c-7a12765afe94101
1091341methylphenidate hydrochloride 1 MG/ML Oral SolutionSCDb9c31526-d486-433c-9b3c-7a12765afe94101
1091341methylphenidate HCl 10 MG per 10 ML Oral SolutionSYb9c31526-d486-433c-9b3c-7a12765afe94101
1091341methylphenidate HCl 5 MG per 5 ML Oral SolutionSYb9c31526-d486-433c-9b3c-7a12765afe94101
1091341methylphenidate hydrochloride 5 MG per 5 ML Oral SolutionSYb9c31526-d486-433c-9b3c-7a12765afe94101
1091133methylphenidate HCl 10 MG in 5 mL Oral SolutionPSN298fb86d-7d94-49e1-b743-3e78011224226
1091341methylphenidate HCl 5 MG in 5 mL Oral SolutionPSN298fb86d-7d94-49e1-b743-3e78011224226
1091341methylphenidate hydrochloride 1 MG/ML Oral SolutionSCD298fb86d-7d94-49e1-b743-3e78011224226
1091133methylphenidate hydrochloride 2 MG/ML Oral SolutionSCD298fb86d-7d94-49e1-b743-3e78011224226
1091341methylphenidate HCl 10 MG per 10 ML Oral SolutionSY298fb86d-7d94-49e1-b743-3e78011224226
1091133methylphenidate HCl 10 MG per 5 ML Oral SolutionSY298fb86d-7d94-49e1-b743-3e78011224226
1091341methylphenidate HCl 5 MG per 5 ML Oral SolutionSY298fb86d-7d94-49e1-b743-3e78011224226
1091133methylphenidate hydrochloride 10 MG per 5 ML Oral SolutionSY298fb86d-7d94-49e1-b743-3e78011224226
1091341methylphenidate hydrochloride 5 MG per 5 ML Oral SolutionSY298fb86d-7d94-49e1-b743-3e78011224226

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71930-024-5271930002452500 mL in 1 BOTTLE (71930-024-52) 500 ml2019-03-290000-00-00NoNoCurrent