FDA.reportPublic FDA data

Methylphenidate Hydrochloride

Product NDC
0406-1810
11-digit product format
004061810
Labeler code
0406
Product ID
0406-1810_8ba92af8-0db9-4347-95c3-bd06680fc85f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylphenidate hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
SpecGx LLC
Application
ANDA203583
Marketing category
ANDA
Marketing start
2015-09-29
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203583-001METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-29
A203583-002METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-29
A203583-003METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-29
A203583-004METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-29
A203583-005METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE50MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-29
A203583-006METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A203583-001AB2
A203583-002AB2
A203583-003AB2
A203583-004AB2
A203583-005AB2
A203583-006AB2

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.

Product history page 1 of 7 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A203583-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-29caaa826d4ba7…
2026-08-18 06:07:402026-07A203583-002METHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-29caaa826d4ba7…
2026-08-18 06:07:402026-07A203583-003METHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-29caaa826d4ba7…
2026-08-18 06:07:402026-07A203583-004METHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-29caaa826d4ba7…
2026-08-18 06:07:402026-07A203583-005METHYLPHENIDATE HYDROCHLORIDE50MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-29caaa826d4ba7…
2026-08-18 06:07:402026-07A203583-006METHYLPHENIDATE HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203583-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203583-002METHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203583-003METHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203583-004METHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203583-005METHYLPHENIDATE HYDROCHLORIDE50MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203583-006METHYLPHENIDATE HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203583-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203583-002METHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203583-003METHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203583-004METHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203583-005METHYLPHENIDATE HYDROCHLORIDE50MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203583-006METHYLPHENIDATE HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A203583-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203583-002METHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203583-003METHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203583-004METHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203583-005METHYLPHENIDATE HYDROCHLORIDE50MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203583-006METHYLPHENIDATE HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203583-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203583-002METHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203583-003METHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203583-004METHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203583-005METHYLPHENIDATE HYDROCHLORIDE50MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203583-006METHYLPHENIDATE HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203583-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203583-002METHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203583-003METHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203583-004METHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203583-005METHYLPHENIDATE HYDROCHLORIDE50MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203583-006METHYLPHENIDATE HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203583-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203583-002METHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203583-003METHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203583-004METHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB22015-09-2903ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A203583-001AB21caaa826d4ba7…
2026-08-18 06:07:402026-07A203583-002AB21caaa826d4ba7…
2026-08-18 06:07:402026-07A203583-003AB21caaa826d4ba7…
2026-08-18 06:07:402026-07A203583-004AB21caaa826d4ba7…
2026-08-18 06:07:402026-07A203583-005AB21caaa826d4ba7…
2026-08-18 06:07:402026-07A203583-006AB21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203583-001AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203583-002AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203583-003AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203583-004AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203583-005AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203583-006AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203583-001AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203583-002AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203583-003AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203583-004AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203583-005AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203583-006AB2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203583-001AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203583-002AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203583-003AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203583-004AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203583-005AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203583-006AB216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203583-001AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203583-002AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203583-003AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203583-004AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203583-005AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203583-006AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203583-001AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203583-002AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203583-003AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203583-004AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203583-005AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203583-006AB21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203583-001AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203583-002AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203583-003AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203583-004AB2103ed91905a0d…

Additional Listing Data#

Finished product
Yes
Brand name base
Methylphenidate Hydrochloride
Brand name suffix
Extended-Release
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 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1806181Internal RxNorm lookup
1806187Internal RxNorm lookup
1806189Internal RxNorm lookup
1806191Internal RxNorm lookup
1806193Internal RxNorm lookup
1806197Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9e11e093-4ff3-4bed-8fe9-3ee460b47303Available 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
0406-1810-01Methylphenidate HydrochlorideExtended-Release100 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE10028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-1810-01EA - Each0406-181038896a84-b993-44a7-85c5-0d6fa5fe7b1912017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT4B3SC438HIMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
METHYLPHENIDATEACTIVE MOIETY207ZZ9QZ49METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
GELATININACTIVE INGREDIENT2G86QN327LMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
POVIDONESINACTIVE INGREDIENTFZ989GH94EMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
SHELLACINACTIVE INGREDIENT46N107B71OMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
SUCROSEINACTIVE INGREDIENTC151H8M554METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-1810METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SPECGX LLC]26Current NDC, Legacy NDC, 1 package rows20241222_9e11e093-4ff3-4bed-8fe9-3ee460b47303.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methylphenidate Hydrochloride Extended-ReleaseMETHYLPHENIDATE HYDROCHLORIDESpecGx LLC9e11e093-4ff3-4bed-8fe9-3ee460b473032025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203583
application number: ANDA203583
ndc (product): 0406-1810

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1806181methylphenidate HCl 10 MG 30/70 Release 24HR Extended Release Oral CapsulePSN9e11e093-4ff3-4bed-8fe9-3ee460b4730328
1806187methylphenidate HCl 20 MG 30/70 Release 24HR Extended Release Oral CapsulePSN9e11e093-4ff3-4bed-8fe9-3ee460b4730328
1806189methylphenidate HCl 30 MG 30/70 Release 24HR Extended Release Oral CapsulePSN9e11e093-4ff3-4bed-8fe9-3ee460b4730328
1806191methylphenidate HCl 40 MG 30/70 Release 24HR Extended Release Oral CapsulePSN9e11e093-4ff3-4bed-8fe9-3ee460b4730328
1806193methylphenidate HCl 50 MG 30/70 Release 24HR Extended Release Oral CapsulePSN9e11e093-4ff3-4bed-8fe9-3ee460b4730328
1806197methylphenidate HCl 60 MG 30/70 Release 24HR Extended Release Oral CapsulePSN9e11e093-4ff3-4bed-8fe9-3ee460b4730328
180618130/70 Release 24 HR methylphenidate hydrochloride 10 MG Extended Release Oral CapsuleSCD9e11e093-4ff3-4bed-8fe9-3ee460b4730328
180618730/70 Release 24 HR methylphenidate hydrochloride 20 MG Extended Release Oral CapsuleSCD9e11e093-4ff3-4bed-8fe9-3ee460b4730328
180618930/70 Release 24 HR methylphenidate hydrochloride 30 MG Extended Release Oral CapsuleSCD9e11e093-4ff3-4bed-8fe9-3ee460b4730328
180619130/70 Release 24 HR methylphenidate hydrochloride 40 MG Extended Release Oral CapsuleSCD9e11e093-4ff3-4bed-8fe9-3ee460b4730328
180619330/70 Release 24 HR methylphenidate hydrochloride 50 MG Extended Release Oral CapsuleSCD9e11e093-4ff3-4bed-8fe9-3ee460b4730328
180619730/70 Release 24 HR methylphenidate hydrochloride 60 MG Extended Release Oral CapsuleSCD9e11e093-4ff3-4bed-8fe9-3ee460b4730328
1806181methylphenidate HCl 10 MG 30/70 Release 24HR Extended Release Oral CapsuleSY9e11e093-4ff3-4bed-8fe9-3ee460b4730328
1806187methylphenidate HCl 20 MG 30/70 Release 24HR Extended Release Oral CapsuleSY9e11e093-4ff3-4bed-8fe9-3ee460b4730328
1806189methylphenidate HCl 30 MG 30/70 Release 24HR Extended Release Oral CapsuleSY9e11e093-4ff3-4bed-8fe9-3ee460b4730328
1806191methylphenidate HCl 40 MG 30/70 Release 24HR Extended Release Oral CapsuleSY9e11e093-4ff3-4bed-8fe9-3ee460b4730328
1806193methylphenidate HCl 50 MG 30/70 Release 24HR Extended Release Oral CapsuleSY9e11e093-4ff3-4bed-8fe9-3ee460b4730328
1806197methylphenidate HCl 60 MG 30/70 Release 24HR Extended Release Oral CapsuleSY9e11e093-4ff3-4bed-8fe9-3ee460b4730328

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0406-1810-0100406181001100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0406-1810-01) 2015-09-290000-00-00NoNoCurrent