FDA.reportPublic FDA data

Dexmethylphenidate Hydrochloride

Product NDC
63629-2172
11-digit product format
636292172
Labeler code
63629
Product ID
63629-2172_b24f0858-f870-4910-8bc9-47fa46da1b38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmethylphenidate Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078992
Marketing category
ANDA
Marketing start
2013-11-19
Substance
DEXMETHYLPHENIDATE HYDROCHLORIDE
Active strength
15 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
Dexmethylphenidate Hydrochloride
Brand name suffix
Extended-Release
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXMETHYLPHENIDATE HYDROCHLORIDE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1678OK0E08
Rxcui899461

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ff349b0-f325-4585-9c0d-7dc58eb1bc1bProduct name120210818
7d5b6b15-5a1e-e1e5-992d-90d0701572adProduct name920210511
ccfbb2ac-2915-4b21-1d79-8a93f773e70fProduct name920200714

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-2172-1Dexmethylphenidate HydrochlorideExtended-Release100 in 1 BOTTLECAPSULE, EXTENDED RELEASE100104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2172-1EA - Each63629-21725a7631f3-37fe-417e-ac29-11584e5df4a612021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2172DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20240601_bb4f32eb-05c7-449e-8e5a-f45781a58f70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
899461dexmethylphenidate HCl 15 MG 24HR Extended Release Oral CapsulePSNbb4f32eb-05c7-449e-8e5a-f45781a58f70104
89946124 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral CapsuleSCDbb4f32eb-05c7-449e-8e5a-f45781a58f70104
899461dexmethylphenidate hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSYbb4f32eb-05c7-449e-8e5a-f45781a58f70104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2172-163629217201100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-2172-1) 2013-11-190000-00-00NoNoCurrent