FDA.reportPublic FDA data

Methylphenidate Hydrochloride

Product NDC
70010-016
11-digit product format
700100016
Labeler code
70010
Product ID
70010-016_40a67d01-89e6-a878-e063-6394a90ae051
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA211796
Marketing category
ANDA
Marketing start
2019-09-10
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
60 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 HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B3SC438HI
Rxcui1806177, 1806179, 1806183, 1806185, 1806195

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
70010-016-03Methylphenidate Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-016-03EA - Each70010-016cb30117a-9fb4-4f1b-90a0-e6be3f571d1112019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-016METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [GRANULES PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 1 package rows20241207_27ea91ad-f64e-43d7-ab10-6f988bca5379.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1806195methylphenidate HCl 10 MG 50/50 Release 24HR Extended Release Oral CapsulePSN27ea91ad-f64e-43d7-ab10-6f988bca537912
1806177methylphenidate HCl 20 MG 50/50 Release 24HR Extended Release Oral CapsulePSN27ea91ad-f64e-43d7-ab10-6f988bca537912
1806179methylphenidate HCl 30 MG 50/50 Release 24HR Extended Release Oral CapsulePSN27ea91ad-f64e-43d7-ab10-6f988bca537912
1806183methylphenidate HCl 40 MG 50/50 Release 24HR Extended Release Oral CapsulePSN27ea91ad-f64e-43d7-ab10-6f988bca537912
1806185methylphenidate HCl 60 MG 50/50 Release 24HR Extended Release Oral CapsulePSN27ea91ad-f64e-43d7-ab10-6f988bca537912
180619550/50 Release 24 HR methylphenidate hydrochloride 10 MG Extended Release Oral CapsuleSCD27ea91ad-f64e-43d7-ab10-6f988bca537912
180617750/50 Release 24 HR methylphenidate hydrochloride 20 MG Extended Release Oral CapsuleSCD27ea91ad-f64e-43d7-ab10-6f988bca537912
180617950/50 Release 24 HR methylphenidate hydrochloride 30 MG Extended Release Oral CapsuleSCD27ea91ad-f64e-43d7-ab10-6f988bca537912
180618350/50 Release 24 HR methylphenidate hydrochloride 40 MG Extended Release Oral CapsuleSCD27ea91ad-f64e-43d7-ab10-6f988bca537912
180618550/50 Release 24 HR methylphenidate hydrochloride 60 MG Extended Release Oral CapsuleSCD27ea91ad-f64e-43d7-ab10-6f988bca537912
1806195methylphenidate HCl 10 MG 50/50 Release 24HR Extended Release Oral CapsuleSY27ea91ad-f64e-43d7-ab10-6f988bca537912
1806177methylphenidate HCl 20 MG 50/50 Release 24HR Extended Release Oral CapsuleSY27ea91ad-f64e-43d7-ab10-6f988bca537912
1806179methylphenidate HCl 30 MG 50/50 Release 24HR Extended Release Oral CapsuleSY27ea91ad-f64e-43d7-ab10-6f988bca537912
1806183methylphenidate HCl 40 MG 50/50 Release 24HR Extended Release Oral CapsuleSY27ea91ad-f64e-43d7-ab10-6f988bca537912
1806185methylphenidate HCl 60 MG 50/50 Release 24HR Extended Release Oral CapsuleSY27ea91ad-f64e-43d7-ab10-6f988bca537912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70010-016-037001000160330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-016-03) 2019-09-100000-00-00NoNoCurrent