Dexmethylphenidate Hydrochloride

Product NDC
63629-2175
11-digit product format
636292175
Labeler code
63629
Product ID
63629-2175_d5e42434-75d6-47ee-a48b-bd0ff19202fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmethylphenidate Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078992
Marketing category
ANDA
Marketing start
2013-11-19
Substance
DEXMETHYLPHENIDATE HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078992-001DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE5MGCAPSULE, EXTENDED RELEASE / ORALAB2021-11-23
A078992-002DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB2021-11-23
A078992-003DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2013-11-18
A078992-004DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2013-11-18
A078992-005DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB2021-11-23
A078992-006DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB2021-11-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078992-001AB
A078992-002AB
A078992-003AB
A078992-004AB
A078992-005AB
A078992-006AB

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 6 · 214 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078992-001DEXMETHYLPHENIDATE HYDROCHLORIDE5MGCAPSULE, EXTENDED RELEASE / ORALAB2021-11-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078992-002DEXMETHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB2021-11-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078992-003DEXMETHYLPHENIDATE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2013-11-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078992-004DEXMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2013-11-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078992-005DEXMETHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB2021-11-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078992-006DEXMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB2021-11-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078992-001DEXMETHYLPHENIDATE HYDROCHLORIDE5MGCAPSULE, EXTENDED RELEASE / ORALAB2021-11-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078992-002DEXMETHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB2021-11-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078992-003DEXMETHYLPHENIDATE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2013-11-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078992-004DEXMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2013-11-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078992-005DEXMETHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB2021-11-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078992-006DEXMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB2021-11-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A078992-001DEXMETHYLPHENIDATE HYDROCHLORIDE5MGCAPSULE, EXTENDED RELEASE / ORALAB2021-11-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078992-002DEXMETHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB2021-11-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078992-003DEXMETHYLPHENIDATE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2013-11-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078992-004DEXMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2013-11-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078992-005DEXMETHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB2021-11-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078992-006DEXMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB2021-11-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078992-001DEXMETHYLPHENIDATE HYDROCHLORIDE5MGCAPSULE, EXTENDED RELEASE / ORALAB2021-11-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078992-002DEXMETHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB2021-11-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078992-003DEXMETHYLPHENIDATE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2013-11-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078992-004DEXMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2013-11-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078992-005DEXMETHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB2021-11-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078992-006DEXMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB2021-11-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078992-001DEXMETHYLPHENIDATE HYDROCHLORIDE5MGCAPSULE, EXTENDED RELEASE / ORALAB2021-11-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078992-002DEXMETHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB2021-11-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078992-003DEXMETHYLPHENIDATE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2013-11-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078992-004DEXMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2013-11-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078992-005DEXMETHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB2021-11-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078992-006DEXMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB2021-11-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078992-001DEXMETHYLPHENIDATE HYDROCHLORIDE5MGCAPSULE, EXTENDED RELEASE / ORALAB2021-11-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078992-002DEXMETHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB2021-11-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078992-003DEXMETHYLPHENIDATE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2013-11-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078992-004DEXMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2013-11-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078992-005DEXMETHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB2021-11-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078992-006DEXMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB2021-11-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078992-001DEXMETHYLPHENIDATE HYDROCHLORIDE5MGCAPSULE, EXTENDED RELEASE / ORALAB2021-11-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078992-002DEXMETHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB2021-11-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078992-003DEXMETHYLPHENIDATE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2013-11-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078992-004DEXMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2013-11-182680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 214 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078992-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078992-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078992-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078992-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078992-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078992-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078992-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078992-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078992-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078992-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078992-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078992-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078992-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078992-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078992-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078992-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078992-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078992-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078992-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078992-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078992-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078992-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078992-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078992-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078992-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078992-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078992-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078992-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078992-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078992-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078992-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078992-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078992-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078992-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078992-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078992-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078992-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078992-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078992-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078992-004AB12680178bc6a6…

Additional Listing Data#

Finished product
Yes
Brand name base
Dexmethylphenidate Hydrochloride
Brand name suffix
Extended-Release
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXMETHYLPHENIDATE HYDROCHLORIDE30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1678OK0E08Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
899495Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
72d7a084-79cf-44c5-a158-fae1fc2faba4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ff349b0-f325-4585-9c0d-7dc58eb1bc1bProduct name120210818
7d5b6b15-5a1e-e1e5-992d-90d0701572adProduct name920210511
ccfbb2ac-2915-4b21-1d79-8a93f773e70fProduct name920200714

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-2175-1Dexmethylphenidate HydrochlorideExtended-Release100 in 1 BOTTLECAPSULE, EXTENDED RELEASE100104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2175-1EA - Each63629-217503fa04c4-f0af-4b85-a8f4-31ac522c6e5012021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2175DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20240601_72d7a084-79cf-44c5-a158-fae1fc2faba4.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dexmethylphenidate Hydrochloride Extended-ReleaseDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepackbb4f32eb-05c7-449e-8e5a-f45781a58f702026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078992
application number: ANDA078992
Dexmethylphenidate Hydrochloride Extended-ReleaseDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack72d7a084-79cf-44c5-a158-fae1fc2faba42026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078992
application number: ANDA078992
ndc (product): 63629-2175
Dexmethylphenidate Hydrochloride Extended-ReleaseDEXMETHYLPHENIDATE HYDROCHLORIDEPar Health USA, LLC4ed9f3c8-c71f-499e-bb91-c19847bf44442026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078992
application number: ANDA078992
Dexmethylphenidate Hydrochloride Extended-ReleaseDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepacka0133bf5-3cb3-4405-a007-43fbcf9573332024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078992
application number: ANDA078992
Dexmethylphenidate Hydrochloride Extended-ReleaseDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack32b3c189-f0f8-4f3e-87da-ce56f583fc422024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078992
application number: ANDA078992

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
899495dexmethylphenidate HCl 30 MG 24HR Extended Release Oral CapsulePSN72d7a084-79cf-44c5-a158-fae1fc2faba4104
89949524 HR dexmethylphenidate hydrochloride 30 MG Extended Release Oral CapsuleSCD72d7a084-79cf-44c5-a158-fae1fc2faba4104
899495dexmethylphenidate hydrochloride 30 MG 24 HR Extended Release Oral CapsuleSY72d7a084-79cf-44c5-a158-fae1fc2faba4104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2175-163629217501100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-2175-1) 2013-11-190000-00-00NoNoCurrent