FDA.reportPublic FDA data

Methylphenidate Hydrochloride

Product NDC
13811-711
11-digit product format
138110711
Labeler code
13811
Product ID
13811-711_ba649db4-df0d-4587-8370-3f866e66e54b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Trigen Laboratories, LLC
Application
NDA216117
Marketing category
NDA AUTHORIZED GENERIC
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
Methylphenidate Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE45 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B3SC438HI
Rxcui2605796, 2605798

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
143536be-f21a-464c-bc5a-163f5c171815Product name220250626
fd4d0878-dcea-3832-288e-e3bbbbe580ffProduct name920240516
435f0341-cf24-41d5-8fbf-c909821e5596Product name120230313
c9b6eabb-08d7-bb2d-e81a-06be3590b436Product name220221216
67aa32c6-44f4-50de-64dd-643e8caf420dProduct name620210622
50b24f34-96fa-4f1e-b262-b0baf4a4a440Product name420210513
cf83c421-eebe-4de2-b1a2-fd96e3dbfcf8Product name120200128
166d1d2d-dd55-4fdf-82e2-b83a3c5347c1Product name120190828
343a61d5-785d-cc27-a43a-0779da054d88Product name320190828
7607489b-cd15-3103-f3b1-d4283574d250Product name220190614
407f0cce-da29-4050-a512-2cabe9e5692dProduct name920190611
f7f4bf1e-7c67-46c6-8c42-9beb1a06b38eProduct name220190415
190572d9-6c7b-4b40-8172-c1b5f802c20fProduct name120180724
2948856e-f76e-d380-d9ed-b317efafbc98Product name520180423
c0aa09de-7aa1-4a98-8f70-62ec3c97c695Product name120170803
3317aade-2d6e-f159-9fe6-e8385a825178Product name320160829
0fe52203-83a7-4fed-a91f-8e47a22cf1d3Product name120160111

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13811-711-30Methylphenidate Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE3048

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13811-711-30EA - Each13811-711b9aa9216-794d-4097-8cd4-b9cd1b1fe43a12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13811-711METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [TRIGEN LABORATORIES, LLC]46Current NDC, Legacy NDC, 1 package rows20231121_dd8d7b6e-c23d-4e16-bb53-959e9127ebc6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2605796methylphenidate HCl 63 MG 24HR Extended Release Oral TabletPSNdd8d7b6e-c23d-4e16-bb53-959e9127ebc648
2605798methylphenidate hydrochloride 45 MG 24HR Extended Release Oral TabletPSNdd8d7b6e-c23d-4e16-bb53-959e9127ebc648
260579824 HR methylphenidate hydrochloride 45 MG Extended Release Oral TabletSCDdd8d7b6e-c23d-4e16-bb53-959e9127ebc648
260579624 HR methylphenidate hydrochloride 63 MG Extended Release Oral TabletSCDdd8d7b6e-c23d-4e16-bb53-959e9127ebc648
2605798methylphenidate hydrochloride 45 MG 24 HR Extended Release Oral TabletSYdd8d7b6e-c23d-4e16-bb53-959e9127ebc648
2605796methylphenidate hydrochloride 63 MG 24 HR Extended Release Oral TabletSYdd8d7b6e-c23d-4e16-bb53-959e9127ebc648

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
13811-711-301381107113030 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-711-30) 2022-06-230000-00-00NoNoCurrent