FDA.reportPublic FDA data

Dexmethylphenidate Hydrochloride

Product NDC
63629-2178
11-digit product format
636292178
Labeler code
63629
Product ID
63629-2178_b056b03d-9115-444c-9bbd-20f3ca7f1608
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmethylphenidate Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202842
Marketing category
ANDA
Marketing start
2017-01-05
Substance
DEXMETHYLPHENIDATE HYDROCHLORIDE
Active strength
5 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
Dexmethylphenidate Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXMETHYLPHENIDATE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1678OK0E08
Rxcui899511

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
63629-2178-1Dexmethylphenidate Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE100104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2178-1EA - Each63629-21782e80e786-44a7-4f0d-8ab3-47d08709cf7312021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2178DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20240816_d3318fec-a1bc-4e3c-86a9-3f00ec296869.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
899511dexmethylphenidate HCl 5 MG 24HR Extended Release Oral CapsulePSNd3318fec-a1bc-4e3c-86a9-3f00ec296869104
89951124 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral CapsuleSCDd3318fec-a1bc-4e3c-86a9-3f00ec296869104
899511dexmethylphenidate hydrochloride 5 MG 24 HR Extended Release Oral CapsuleSYd3318fec-a1bc-4e3c-86a9-3f00ec296869104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2178-163629217801100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-2178-1) 2024-08-080000-00-00NoNoCurrent