FDA.reportPublic FDA data

Methylphenidate Hydrochloride

Product NDC
0406-1146
11-digit product format
004061146
Labeler code
0406
Product ID
0406-1146_3c286d0f-d6c0-47f5-af8b-9a744477a11f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
SpecGx LLC
Application
ANDA040300
Marketing category
ANDA
Marketing start
1998-11-27
Substance
METHYLPHENIDATE 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

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040300-001METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB1998-11-27
A040300-002METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORALAB1998-11-27
A040300-003METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORALAB1998-11-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A040300-001AB
A040300-002AB
A040300-003AB

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 22:54:322026-06A040300-001METHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB1998-11-27a50c72e98297…
2026-08-01 22:54:322026-06A040300-002METHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORALAB1998-11-27a50c72e98297…
2026-08-01 22:54:322026-06A040300-003METHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORALAB1998-11-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A040300-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A040300-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A040300-003AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEAmerican Health Packagingeb9b7377-d918-43fb-8e82-d14c85ed64a82025-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040300
application number: ANDA040300
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDESpecGx LLC981a2ad8-33f7-4678-9162-9df9685bd4a62023-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040300
application number: ANDA040300
ndc (product): 0406-1146

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE20 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1091150Internal RxNorm lookup
1091392Internal RxNorm lookup
1091497Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
981a2ad8-33f7-4678-9162-9df9685bd4a6Available 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
0406-1146-01Methylphenidate Hydrochloride100 in 1 BOTTLETABLET10044
0406-1146-10Methylphenidate Hydrochloride1000 in 1 BOTTLETABLET100044

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-1146-01EA - Each0406-1146263576d1-81a0-4782-ac36-e9d418ca990912012-07-24
0406-1146-10EA - Each0406-114638523dd7-ec04-4dcf-9ff4-593431fafe5012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT4B3SC438HIMETHYLPHENIDATE HYDROCHLORIDE TABLET METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]29
METHYLPHENIDATEACTIVE MOIETY207ZZ9QZ49METHYLPHENIDATE HYDROCHLORIDE TABLET METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]29
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETHYLPHENIDATE HYDROCHLORIDE TABLET METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]29
HYPROMELLOSE 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2METHYLPHENIDATE HYDROCHLORIDE TABLET METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]29
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETHYLPHENIDATE HYDROCHLORIDE TABLET METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]29
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHYLPHENIDATE HYDROCHLORIDE TABLET METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]29
TALCINACTIVE INGREDIENT7SEV7J4R1UMETHYLPHENIDATE HYDROCHLORIDE TABLET METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]29

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-1146METHYLPHENIDATE HYDROCHLORIDE TABLET [SPECGX LLC]44Current NDC, Legacy NDC, 2 package rows20240724_981a2ad8-33f7-4678-9162-9df9685bd4a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091150methylphenidate HCl 10 MG Oral TabletPSN981a2ad8-33f7-4678-9162-9df9685bd4a644
1091392methylphenidate HCl 20 MG Oral TabletPSN981a2ad8-33f7-4678-9162-9df9685bd4a644
1091497methylphenidate HCl 5 MG Oral TabletPSN981a2ad8-33f7-4678-9162-9df9685bd4a644
1091150methylphenidate hydrochloride 10 MG Oral TabletSCD981a2ad8-33f7-4678-9162-9df9685bd4a644
1091392methylphenidate hydrochloride 20 MG Oral TabletSCD981a2ad8-33f7-4678-9162-9df9685bd4a644
1091497methylphenidate hydrochloride 5 MG Oral TabletSCD981a2ad8-33f7-4678-9162-9df9685bd4a644

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0406-1146-0100406114601100 TABLET in 1 BOTTLE (0406-1146-01) 100 tablet1998-11-270000-00-00NoNoCurrent
0406-1146-10004061146101000 TABLET in 1 BOTTLE (0406-1146-10) 1000 tablet1998-11-270000-00-00NoNoCurrent