FDA.reportPublic FDA data

Methylphenidate Hydrochloride

Product NDC
57664-608
11-digit product format
576640608
Labeler code
57664
Product ID
57664-608_509cf8be-4306-9755-e063-6294a90ab425
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA205135
Marketing category
ANDA
Marketing start
2020-08-20
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
36 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 HYDROCHLORIDE36 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B3SC438HI
Rxcui1091155, 1091170, 1091185, 1091210

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
57664-608-88Methylphenidate Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-608-88EA - Each57664-608bc619047-3ec0-45d2-b927-8912bc724b8612021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-608METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]3Current NDC, Legacy NDC, 1 package rows20240110_d048e52d-7406-4fc1-9a72-c073bafc7439.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091155methylphenidate HCl 18 MG 24HR Extended Release Oral TabletPSNd048e52d-7406-4fc1-9a72-c073bafc74396
1091170methylphenidate HCl 27 MG 24HR Extended Release Oral TabletPSNd048e52d-7406-4fc1-9a72-c073bafc74396
1091185methylphenidate HCl 36 MG 24HR Extended Release Oral TabletPSNd048e52d-7406-4fc1-9a72-c073bafc74396
1091210methylphenidate HCl 54 MG 24HR Extended Release Oral TabletPSNd048e52d-7406-4fc1-9a72-c073bafc74396
109115524 HR methylphenidate hydrochloride 18 MG Extended Release Oral TabletSCDd048e52d-7406-4fc1-9a72-c073bafc74396
109117024 HR methylphenidate hydrochloride 27 MG Extended Release Oral TabletSCDd048e52d-7406-4fc1-9a72-c073bafc74396
109118524 HR methylphenidate hydrochloride 36 MG Extended Release Oral TabletSCDd048e52d-7406-4fc1-9a72-c073bafc74396
109121024 HR methylphenidate hydrochloride 54 MG Extended Release Oral TabletSCDd048e52d-7406-4fc1-9a72-c073bafc74396
1091155methylphenidate hydrochloride 18 MG 24 HR Extended Release Oral TabletSYd048e52d-7406-4fc1-9a72-c073bafc74396
1091170methylphenidate hydrochloride 27 MG 24 HR Extended Release Oral TabletSYd048e52d-7406-4fc1-9a72-c073bafc74396
1091185methylphenidate hydrochloride 36 MG 24 HR Extended Release Oral TabletSYd048e52d-7406-4fc1-9a72-c073bafc74396
1091210methylphenidate hydrochloride 54 MG 24 HR Extended Release Oral TabletSYd048e52d-7406-4fc1-9a72-c073bafc74396

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57664-608-8857664060888100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (57664-608-88) 2020-08-200000-00-00NoNoCurrent