FDA.reportPublic FDA data

METHYLPHENIDATE HYDROCHLORIDE

Product NDC
70752-132
11-digit product format
707520132
Labeler code
70752
Product ID
70752-132_80b36f9d-4d27-46af-837b-70d2daec0dba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHYLPHENIDATE HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
QUAGEN PHARMACEUTICALS LLC
Application
ANDA213567
Marketing category
ANDA
Marketing start
2020-06-04
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70752-132-142023-02-02C16284748780-1f386c64a-21af-0266-e053-dadaa90a7c1aMethylphenidate HCl Oral Solution, 5 mg/5 mL Methylphenidate HCl Oral Solution, 10 mg/5 mL CII Rx only
70752-132-142023-01-30C16284748780-1f386c64a-21af-0266-e053-dadaa90a7c1aMethylphenidate HCl Oral Solution, 5 mg/5 mL Methylphenidate HCl Oral Solution, 10 mg/5 mL CII Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70752-132-14METHYLPHENIDATE HYDROCHLORIDE500 mL in 1 BOTTLE, PLASTICSOLUTION5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70752-132-14ML - Milliliter70752-1325c31d390-c39e-487a-9384-0d8e729d54c112020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70752-132METHYLPHENIDATE HYDROCHLORIDE SOLUTION [QUAGEN PHARMACEUTICALS LLC]2Current NDC, Legacy NDC, 1 package rows20230203_59de488c-c3f8-415d-9e9f-9102c090aac8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091133methylphenidate HCl 10 MG in 5 mL Oral SolutionPSN59de488c-c3f8-415d-9e9f-9102c090aac82
1091341methylphenidate HCl 5 MG in 5 mL Oral SolutionPSN59de488c-c3f8-415d-9e9f-9102c090aac82
1091341methylphenidate hydrochloride 1 MG/ML Oral SolutionSCD59de488c-c3f8-415d-9e9f-9102c090aac82
1091133methylphenidate hydrochloride 2 MG/ML Oral SolutionSCD59de488c-c3f8-415d-9e9f-9102c090aac82
1091341methylphenidate HCl 10 MG per 10 ML Oral SolutionSY59de488c-c3f8-415d-9e9f-9102c090aac82
1091133methylphenidate HCl 10 MG per 5 ML Oral SolutionSY59de488c-c3f8-415d-9e9f-9102c090aac82
1091341methylphenidate HCl 5 MG per 5 ML Oral SolutionSY59de488c-c3f8-415d-9e9f-9102c090aac82
1091133methylphenidate hydrochloride 10 MG per 5 ML Oral SolutionSY59de488c-c3f8-415d-9e9f-9102c090aac82
1091341methylphenidate hydrochloride 5 MG per 5 ML Oral SolutionSY59de488c-c3f8-415d-9e9f-9102c090aac82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70752-132-1470752013214500 mL in 1 BOTTLE, PLASTIC (70752-132-14) 500 ml2020-06-040000-00-00NoNoCurrent