FDA.reportPublic FDA data

Methylphenidate Hydrochloride

Product NDC
0406-0127
11-digit product format
004060127
Labeler code
0406
Product ID
0406-0127_24d8e2c3-6e4d-44b8-aafe-7c713b11af5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
SpecGx LLC
Application
ANDA202608
Marketing category
ANDA
Marketing start
2012-12-28
Marketing end
2027-06-30
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
27 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A202608-001METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORAL2012-12-28
A202608-002METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORAL2012-12-28
A202608-003METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORAL2012-12-28

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 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A202608-001METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORAL2012-12-28c2088c7a36db…
2026-10-15 13:18:302026-09A202608-002METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORAL2012-12-28c2088c7a36db…
2026-10-15 13:18:302026-09A202608-003METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORAL2012-12-28c2088c7a36db…
2026-09-14 22:38:342026-08A202608-001METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORAL2012-12-2884e616aacf4f…
2026-09-14 22:38:342026-08A202608-002METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORAL2012-12-2884e616aacf4f…
2026-09-14 22:38:342026-08A202608-003METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORAL2012-12-2884e616aacf4f…
2026-08-18 06:07:402026-07A202608-001METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORAL2012-12-28caaa826d4ba7…
2026-08-18 06:07:402026-07A202608-002METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORAL2012-12-28caaa826d4ba7…
2026-08-18 06:07:402026-07A202608-003METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORAL2012-12-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202608-001METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALBX2012-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202608-002METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALBX2012-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202608-003METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALBX2012-12-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202608-001METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALBX2012-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202608-002METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALBX2012-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202608-003METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALBX2012-12-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A202608-001METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALBX2012-12-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202608-002METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALBX2012-12-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202608-003METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALBX2012-12-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202608-001METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALBX2012-12-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202608-002METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALBX2012-12-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202608-003METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALBX2012-12-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202608-001METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALBX2012-12-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202608-002METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALBX2012-12-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202608-003METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALBX2012-12-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202608-001METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALBX2012-12-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202608-002METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALBX2012-12-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202608-003METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALBX2012-12-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202608-001METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALBX2012-12-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202608-002METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALBX2012-12-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202608-003METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALBX2012-12-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202608-001METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALBX2012-12-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202608-002METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALBX2012-12-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202608-003METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALBX2012-12-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202608-001METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALBX2012-12-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202608-002METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALBX2012-12-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202608-003METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALBX2012-12-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202608-001METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALBX2012-12-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A202608-002METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALBX2012-12-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A202608-003METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALBX2012-12-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202608-001METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALBX2012-12-2879d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 120 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-05-31 18:47 UTC2024-05A202608-002BX18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202608-003BX18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202608-001BX15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202608-002BX15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202608-003BX15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202608-001BX15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202608-002BX15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202608-003BX15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202608-001BX14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202608-002BX14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202608-003BX14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202608-001BX174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202608-002BX174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202608-003BX174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202608-001BX1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202608-002BX1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202608-003BX1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202608-001BX1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202608-002BX1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202608-003BX1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202608-001BX187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202608-002BX187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202608-003BX187673890dc5c…
2021-03-12 10:30 UTC2021-03A202608-001BX15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A202608-002BX15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A202608-003BX15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202608-001BX18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A202608-002BX18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A202608-003BX18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202608-001BX1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A202608-002BX1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A202608-003BX1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202608-001BX13f01610625f2…
2019-12-14 00:12 UTC2019-12A202608-002BX13f01610625f2…
2019-12-14 00:12 UTC2019-12A202608-003BX13f01610625f2…
2019-09-15 20:21 UTC2019-09A202608-001BX1b00525d2431f…
2019-09-15 20:21 UTC2019-09A202608-002BX1b00525d2431f…
2019-09-15 20:21 UTC2019-09A202608-003BX1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202608-001BX1ea99ee380514…
2019-07-19 19:46 UTC2019-07A202608-002BX1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Methylphenidate Hydrochloride
Brand name suffix
Extended-Release

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE27 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
2001565Internal RxNorm lookup
2001566Internal RxNorm lookup
2001568Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b1b0f2ff-d9df-42ab-b471-226ecf97e075Available 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
0406-0127-01Methylphenidate HydrochlorideExtended-Release100 in 1 BOTTLETABLET, EXTENDED RELEASE10034

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-0127-01EA - Each0406-0127f3e8a39a-f662-46c4-9550-4e5607b388cf12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT4B3SC438HIMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
METHYLPHENIDATEACTIVE MOIETY207ZZ9QZ49METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
SHELLACINACTIVE INGREDIENT46N107B71OMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
TALCINACTIVE INGREDIENT7SEV7J4R1UMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
TRIACETININACTIVE INGREDIENTXHX3C3X673METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-0127METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SPECGX LLC]34Current NDC, Legacy NDC, 1 package rows20241103_b1b0f2ff-d9df-42ab-b471-226ecf97e075.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 LLCb1b0f2ff-d9df-42ab-b471-226ecf97e0752024-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202608
application number: ANDA202608
ndc (product): 0406-0127

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2001565methylphenidate HCl 27 MG 24HR Extended Release Oral Tablet, BX RatingPSNb1b0f2ff-d9df-42ab-b471-226ecf97e07534
2001566methylphenidate HCl 36 MG 24HR Extended Release Oral Tablet, BX RatingPSNb1b0f2ff-d9df-42ab-b471-226ecf97e07534
2001568methylphenidate HCl 54 MG 24HR Extended Release Oral Tablet, BX RatingPSNb1b0f2ff-d9df-42ab-b471-226ecf97e07534
2001565BX Rating 24 HR methylphenidate hydrochloride 27 MG Extended Release Oral TabletSCDb1b0f2ff-d9df-42ab-b471-226ecf97e07534
2001566BX Rating 24 HR methylphenidate hydrochloride 36 MG Extended Release Oral TabletSCDb1b0f2ff-d9df-42ab-b471-226ecf97e07534
2001568BX Rating 24 HR methylphenidate hydrochloride 54 MG Extended Release Oral TabletSCDb1b0f2ff-d9df-42ab-b471-226ecf97e07534
2001565methylphenidate HCl 27 MG 24HR Extended Release Oral Tablet, BX RatingSYb1b0f2ff-d9df-42ab-b471-226ecf97e07534
2001566methylphenidate HCl 36 MG 24HR Extended Release Oral Tablet, BX RatingSYb1b0f2ff-d9df-42ab-b471-226ecf97e07534
2001568methylphenidate HCl 54 MG 24HR Extended Release Oral Tablet, BX RatingSYb1b0f2ff-d9df-42ab-b471-226ecf97e07534

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0406-0127-0100406012701100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-0127-01) 2012-12-282027-06-30NoNoCurrent