FDA.reportPublic FDA data

RELEXXII

Product NDC
68025-088
11-digit product format
680250088
Labeler code
68025
Product ID
68025-088_86f477e9-07fc-466b-913e-1a4434c91df4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylphenidate hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Vertical Pharmaceuticals, LLC
Application
NDA216117
Marketing category
NDA
Marketing start
2022-06-23
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
45 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
RELEXXII
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE45 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B3SC438HI
Rxcui1091155, 1091170, 1091185, 1091210, 1995461, 2052826, 2605796, 2605798, 2605943, 2605946, 2668496, 2668499, 2668502, 2668505

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
143536be-f21a-464c-bc5a-163f5c171815Product name220250626
fd4d0878-dcea-3832-288e-e3bbbbe580ffProduct name920240516
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
435f0341-cf24-41d5-8fbf-c909821e5596Product name120230313
c9b6eabb-08d7-bb2d-e81a-06be3590b436Product name220221216
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
67aa32c6-44f4-50de-64dd-643e8caf420dProduct name620210622
50b24f34-96fa-4f1e-b262-b0baf4a4a440Product name420210513
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
cf83c421-eebe-4de2-b1a2-fd96e3dbfcf8Product name120200128
166d1d2d-dd55-4fdf-82e2-b83a3c5347c1Product name120190828
343a61d5-785d-cc27-a43a-0779da054d88Product name320190828
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
7607489b-cd15-3103-f3b1-d4283574d250Product name220190614
407f0cce-da29-4050-a512-2cabe9e5692dProduct name920190611
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
f7f4bf1e-7c67-46c6-8c42-9beb1a06b38eProduct name220190415
190572d9-6c7b-4b40-8172-c1b5f802c20fProduct name120180724
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
2948856e-f76e-d380-d9ed-b317efafbc98Product name520180423
c0aa09de-7aa1-4a98-8f70-62ec3c97c695Product name120170803
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
3317aade-2d6e-f159-9fe6-e8385a825178Product name320160829
0fe52203-83a7-4fed-a91f-8e47a22cf1d3Product name120160111
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68025-088-30RELEXXII30 in 1 BOTTLETABLET, EXTENDED RELEASE3018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68025-088RELEXXII (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [VERTICAL PHARMACEUTICALS, LLC]17Current NDC, Legacy NDC, 1 package rows20240809_22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091155methylphenidate HCl 18 MG 24HR Extended Release Oral TabletPSN22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
1091170methylphenidate HCl 27 MG 24HR Extended Release Oral TabletPSN22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
1091185methylphenidate HCl 36 MG 24HR Extended Release Oral TabletPSN22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
1091210methylphenidate HCl 54 MG 24HR Extended Release Oral TabletPSN22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
2605796methylphenidate HCl 63 MG 24HR Extended Release Oral TabletPSN22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
1995461methylphenidate HCl 72 MG 24HR Extended Release Oral TabletPSN22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
2605798methylphenidate hydrochloride 45 MG 24HR Extended Release Oral TabletPSN22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
2668496RELEXXII 18 MG 24HR Extended Release Oral TabletPSN22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
2668499RELEXXII 27 MG 24HR Extended Release Oral TabletPSN22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
2668502RELEXXII 36 MG 24HR Extended Release Oral TabletPSN22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
2605943RELEXXII 45 MG 24HR Extended Release Oral TabletPSN22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
2668505RELEXXII 54 MG 24HR Extended Release Oral TabletPSN22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
2605946RELEXXII 63 MG 24HR Extended Release Oral TabletPSN22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
2052826RELEXXII 72 MG 24HR Extended Release Oral TabletPSN22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
266849624 HR methylphenidate hydrochloride 18 MG Extended Release Oral Tablet [Relexxii]SBD22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
266849924 HR methylphenidate hydrochloride 27 MG Extended Release Oral Tablet [Relexxii]SBD22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
266850224 HR methylphenidate hydrochloride 36 MG Extended Release Oral Tablet [Relexxii]SBD22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
260594324 HR methylphenidate hydrochloride 45 MG Extended Release Oral Tablet [Relexxii]SBD22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
266850524 HR methylphenidate hydrochloride 54 MG Extended Release Oral Tablet [Relexxii]SBD22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
260594624 HR methylphenidate hydrochloride 63 MG Extended Release Oral Tablet [Relexxii]SBD22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
205282624 HR methylphenidate hydrochloride 72 MG Extended Release Oral Tablet [Relexxii]SBD22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
109115524 HR methylphenidate hydrochloride 18 MG Extended Release Oral TabletSCD22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
109117024 HR methylphenidate hydrochloride 27 MG Extended Release Oral TabletSCD22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
109118524 HR methylphenidate hydrochloride 36 MG Extended Release Oral TabletSCD22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
260579824 HR methylphenidate hydrochloride 45 MG Extended Release Oral TabletSCD22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
109121024 HR methylphenidate hydrochloride 54 MG Extended Release Oral TabletSCD22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
260579624 HR methylphenidate hydrochloride 63 MG Extended Release Oral TabletSCD22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
199546124 HR methylphenidate hydrochloride 72 MG Extended Release Oral TabletSCD22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
266849624 HR Relexxii 18 MG Extended Release Oral TabletSY22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
266849924 HR Relexxii 27 MG Extended Release Oral TabletSY22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
266850224 HR Relexxii 36 MG Extended Release Oral TabletSY22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
266850524 HR Relexxii 54 MG Extended Release Oral TabletSY22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
205282624 HR Relexxii 72 MG Extended Release Oral TabletSY22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
1091155methylphenidate hydrochloride 18 MG 24 HR Extended Release Oral TabletSY22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
1091170methylphenidate hydrochloride 27 MG 24 HR Extended Release Oral TabletSY22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
1091185methylphenidate hydrochloride 36 MG 24 HR Extended Release Oral TabletSY22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
2605798methylphenidate hydrochloride 45 MG 24 HR Extended Release Oral TabletSY22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
1091210methylphenidate hydrochloride 54 MG 24 HR Extended Release Oral TabletSY22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
2605796methylphenidate hydrochloride 63 MG 24 HR Extended Release Oral TabletSY22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
1995461methylphenidate hydrochloride 72 MG 24 HR Extended Release Oral TabletSY22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
2668496Relexxii 18 MG 24 HR Extended Release Oral TabletSY22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
2668499Relexxii 27 MG 24 HR Extended Release Oral TabletSY22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
2668502Relexxii 36 MG 24 HR Extended Release Oral TabletSY22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
2605943Relexxii 45 MG 24 HR Extended Release Oral TabletSY22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
2668505Relexxii 54 MG 24 HR Extended Release Oral TabletSY22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
2605946Relexxii 63 MG 24 HR Extended Release Oral TabletSY22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18
2052826Relexxii 72 MG 24 HR Extended Release Oral TabletSY22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68025-088-1068025008810100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-088-10) 2022-06-230000-00-00NoNoCurrent
68025-088-306802500883030 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-088-30) 2022-06-230000-00-00NoNoCurrent