Methylphenidate Hydrochloride

Product NDC
40032-575
11-digit product format
400320575
Labeler code
40032
Product ID
40032-575_07e58ef7-4278-4994-a6f3-ac37d27c3655
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Novel Laboratories, Inc.
Application
ANDA207884
Marketing category
ANDA
Marketing start
2015-11-13
Marketing end
0000-00-00
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40032-575-01Methylphenidate Hydrochloride100 in 1 BOTTLETABLET1004
40032-575-03Methylphenidate Hydrochloride30 in 1 BOTTLETABLET304
40032-575-05Methylphenidate Hydrochloride500 in 1 BOTTLETABLET5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40032-575METHYLPHENIDATE HYDROCHLORIDE TABLET [NOVEL LABORATORIES, INC.]4Legacy NDC, 3 package rows20160106_e5e705f5-e4f2-46c0-a157-1b4f7413807e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091150methylphenidate HCl 10 MG Oral TabletPSNe5e705f5-e4f2-46c0-a157-1b4f7413807e4
1091392methylphenidate HCl 20 MG Oral TabletPSNe5e705f5-e4f2-46c0-a157-1b4f7413807e4
1091497methylphenidate HCl 5 MG Oral TabletPSNe5e705f5-e4f2-46c0-a157-1b4f7413807e4
1091150methylphenidate hydrochloride 10 MG Oral TabletSCDe5e705f5-e4f2-46c0-a157-1b4f7413807e4
1091392methylphenidate hydrochloride 20 MG Oral TabletSCDe5e705f5-e4f2-46c0-a157-1b4f7413807e4
1091497methylphenidate hydrochloride 5 MG Oral TabletSCDe5e705f5-e4f2-46c0-a157-1b4f7413807e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
40032-575-0140032057501100 in 1 BOTTLEHistorical
40032-575-034003205750330 in 1 BOTTLEHistorical
40032-575-0540032057505500 in 1 BOTTLEHistorical