FDA.reportPublic FDA data

Methylphenidate Hydrochloride

Product NDC
0406-1445
11-digit product format
004061445
Labeler code
0406
Product ID
0406-1445_7bfd27d5-70ed-440b-949a-140aa3304d4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
SpecGx LLC
Application
ANDA075629
Marketing category
ANDA
Marketing start
2000-05-09
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
10 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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0406-1445DDiscontinued by firm2026-08-03
excluded packagepackage0406-14450406-1445-01DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075629-001METHYLIN ERMETHYLPHENIDATE HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2000-05-09
A075629-002METHYLIN ERMETHYLPHENIDATE HYDROCHLORIDE20MGTABLET, EXTENDED RELEASE / ORALAB2000-05-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A075629-001AB
A075629-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A075629-001METHYLIN ER10MGTABLET, EXTENDED RELEASE / ORALAB2000-05-09a50c72e98297…
2026-08-01 22:54:322026-06A075629-002METHYLIN ER20MGTABLET, EXTENDED RELEASE / ORALAB2000-05-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075629-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A075629-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDESpecGx LLCed004cf0-eb23-43d2-96dc-20c4ad63824f2025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075629
application number: ANDA075629
ndc (product): 0406-1445

Additional Listing Data#

Finished product
Yes
Brand name base
Methylphenidate Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4B3SC438HIInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1091145Internal RxNorm lookup
1091225Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ed004cf0-eb23-43d2-96dc-20c4ad63824fAvailable on FDA.report

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
0406-1445-01Methylphenidate Hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-1445-01EA - Each0406-14459ca8c853-b0c0-44c1-99e2-e047b8b5f2da12012-07-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-1445METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SPECGX LLC]1Current NDC, Legacy NDC, 1 package rows20240713_ed004cf0-eb23-43d2-96dc-20c4ad63824f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091145methylphenidate HCl 10 MG 8HR Extended Release Oral TabletPSNed004cf0-eb23-43d2-96dc-20c4ad63824f3
1091225methylphenidate HCl 20 MG 8HR Extended Release Oral TabletPSNed004cf0-eb23-43d2-96dc-20c4ad63824f3
10911458 HR methylphenidate hydrochloride 10 MG Extended Release Oral TabletSCDed004cf0-eb23-43d2-96dc-20c4ad63824f3
10912258 HR methylphenidate hydrochloride 20 MG Extended Release Oral TabletSCDed004cf0-eb23-43d2-96dc-20c4ad63824f3
1091145methylphenidate HCl 10 MG 8 HR Extended Release Oral TabletSYed004cf0-eb23-43d2-96dc-20c4ad63824f3
1091225methylphenidate HCl 20 MG 8 HR Extended Release Oral TabletSYed004cf0-eb23-43d2-96dc-20c4ad63824f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0406-1445-0100406144501100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-1445-01) 2000-05-090000-00-00NoNoCurrent