FDA.reportPublic FDA data

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product NDC
70010-007
11-digit product format
700100007
Labeler code
70010
Product ID
70010-007_412b7fd8-c12a-36c2-e063-6394a90acae6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA213813
Marketing category
ANDA
Marketing start
2020-12-01
Substance
DEXMETHYLPHENIDATE HYDROCHLORIDE
Active strength
20 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 HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1678OK0E08
Rxcui899439, 899461, 899485, 899495, 899511, 1006608, 1101926, 1101932

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
70010-007-01DEXMETHYLPHENIDATE HYDROCHLORIDE100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-007DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [GRANULES PHARMACEUTICALS INC.]8Current NDC, Legacy NDC, 1 package rows20231111_abe6862b-3cf3-4aad-98ea-05a5fb54ebec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
899439dexmethylphenidate HCl 10 MG 24HR Extended Release Oral CapsulePSNabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
899461dexmethylphenidate HCl 15 MG 24HR Extended Release Oral CapsulePSNabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
899485dexmethylphenidate HCl 20 MG 24HR Extended Release Oral CapsulePSNabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
1101926dexmethylphenidate HCl 25 MG 24HR Extended Release Oral CapsulePSNabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
899495dexmethylphenidate HCl 30 MG 24HR Extended Release Oral CapsulePSNabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
1101932dexmethylphenidate HCl 35 MG 24HR Extended Release Oral CapsulePSNabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
1006608dexmethylphenidate HCl 40 MG 24HR Extended Release Oral CapsulePSNabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
899511dexmethylphenidate HCl 5 MG 24HR Extended Release Oral CapsulePSNabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
89943924 HR dexmethylphenidate hydrochloride 10 MG Extended Release Oral CapsuleSCDabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
89946124 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral CapsuleSCDabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
89948524 HR dexmethylphenidate hydrochloride 20 MG Extended Release Oral CapsuleSCDabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
110192624 HR dexmethylphenidate hydrochloride 25 MG Extended Release Oral CapsuleSCDabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
89949524 HR dexmethylphenidate hydrochloride 30 MG Extended Release Oral CapsuleSCDabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
110193224 HR dexmethylphenidate hydrochloride 35 MG Extended Release Oral CapsuleSCDabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
100660824 HR dexmethylphenidate hydrochloride 40 MG Extended Release Oral CapsuleSCDabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
89951124 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral CapsuleSCDabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
899439dexmethylphenidate hydrochloride 10 MG 24 HR Extended Release Oral CapsuleSYabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
899461dexmethylphenidate hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSYabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
899485dexmethylphenidate hydrochloride 20 MG 24 HR Extended Release Oral CapsuleSYabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
1101926dexmethylphenidate hydrochloride 25 MG 24 HR Extended Release Oral CapsuleSYabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
899495dexmethylphenidate hydrochloride 30 MG 24 HR Extended Release Oral CapsuleSYabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
1101932dexmethylphenidate hydrochloride 35 MG 24 HR Extended Release Oral CapsuleSYabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
1006608dexmethylphenidate hydrochloride 40 MG 24 HR Extended Release Oral CapsuleSYabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
899511dexmethylphenidate hydrochloride 5 MG 24 HR Extended Release Oral CapsuleSYabe6862b-3cf3-4aad-98ea-05a5fb54ebec9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70010-007-0170010000701100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-007-01) 2020-12-010000-00-00NoNoCurrent