Dexmethylphenidate hydrochloride

Product NDC
16714-564
11-digit product format
167140564
Labeler code
16714
Product ID
16714-564_2885e800-bd09-4031-b069-8bb153e15b98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmethylphenidate hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Northstar Rx LLC
Application
ANDA206734
Marketing category
ANDA
Marketing start
2022-01-21
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-564-01EA - Each16714-564bbc3b841-0090-46a1-94ed-9f320f27672612022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-564DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NORTHSTAR RX LLC]3Legacy NDC20250114_b58a3015-fbf3-4ad7-a9f4-3a9cbc3e4258.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-564-0116714056401100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16714-564-01) 2022-01-210000-00-00NoNoCurrent