FDA.reportPublic FDA data

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product NDC
31722-230
11-digit product format
317220230
Labeler code
31722
Product ID
31722-230_81c8ba81-82ac-4c18-b28b-da9c71520f35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexmethylphenidate hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA215523
Marketing category
ANDA
Marketing start
2021-12-08
Substance
DEXMETHYLPHENIDATE 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 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215523-001DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE5MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-08
A215523-002DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-08
A215523-003DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-08
A215523-004DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-08
A215523-005DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE25MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-08
A215523-006DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-08
A215523-007DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE35MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-08
A215523-008DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-productTE code
A215523-001AB
A215523-002AB
A215523-003AB
A215523-004AB
A215523-005AB
A215523-006AB
A215523-007AB
A215523-008AB

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 · 272 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A215523-001DEXMETHYLPHENIDATE HYDROCHLORIDE5MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-08caaa826d4ba7…
2026-08-18 06:07:402026-07A215523-002DEXMETHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-08caaa826d4ba7…
2026-08-18 06:07:402026-07A215523-003DEXMETHYLPHENIDATE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-08caaa826d4ba7…
2026-08-18 06:07:402026-07A215523-004DEXMETHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-08caaa826d4ba7…
2026-08-18 06:07:402026-07A215523-005DEXMETHYLPHENIDATE HYDROCHLORIDE25MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-08caaa826d4ba7…
2026-08-18 06:07:402026-07A215523-006DEXMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-08caaa826d4ba7…
2026-08-18 06:07:402026-07A215523-007DEXMETHYLPHENIDATE HYDROCHLORIDE35MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-08caaa826d4ba7…
2026-08-18 06:07:402026-07A215523-008DEXMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215523-001DEXMETHYLPHENIDATE HYDROCHLORIDE5MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215523-002DEXMETHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215523-003DEXMETHYLPHENIDATE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215523-004DEXMETHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215523-005DEXMETHYLPHENIDATE HYDROCHLORIDE25MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215523-006DEXMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215523-007DEXMETHYLPHENIDATE HYDROCHLORIDE35MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215523-008DEXMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215523-001DEXMETHYLPHENIDATE HYDROCHLORIDE5MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215523-002DEXMETHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215523-003DEXMETHYLPHENIDATE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215523-004DEXMETHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215523-005DEXMETHYLPHENIDATE HYDROCHLORIDE25MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215523-006DEXMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215523-007DEXMETHYLPHENIDATE HYDROCHLORIDE35MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215523-008DEXMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A215523-001DEXMETHYLPHENIDATE HYDROCHLORIDE5MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215523-002DEXMETHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215523-003DEXMETHYLPHENIDATE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215523-004DEXMETHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215523-005DEXMETHYLPHENIDATE HYDROCHLORIDE25MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215523-006DEXMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215523-007DEXMETHYLPHENIDATE HYDROCHLORIDE35MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215523-008DEXMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215523-001DEXMETHYLPHENIDATE HYDROCHLORIDE5MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215523-002DEXMETHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215523-003DEXMETHYLPHENIDATE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215523-004DEXMETHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215523-005DEXMETHYLPHENIDATE HYDROCHLORIDE25MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215523-006DEXMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215523-007DEXMETHYLPHENIDATE HYDROCHLORIDE35MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215523-008DEXMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB2021-12-08fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 272 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A215523-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215523-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215523-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215523-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215523-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215523-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215523-007AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215523-008AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215523-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215523-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215523-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215523-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215523-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215523-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215523-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215523-008AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215523-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215523-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215523-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215523-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215523-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215523-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215523-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215523-008AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215523-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215523-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215523-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215523-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215523-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215523-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215523-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215523-008AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215523-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215523-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215523-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215523-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215523-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215523-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215523-007AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215523-008AB1fd3edfee7708…

Additional Listing Data#

Finished product
Yes
Brand name base
DEXMETHYLPHENIDATE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXMETHYLPHENIDATE HYDROCHLORIDE10 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 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
899439Internal RxNorm lookup
899461Internal RxNorm lookup
899485Internal RxNorm lookup
899495Internal RxNorm lookup
899511Internal RxNorm lookup
1006608Internal RxNorm lookup
1101926Internal RxNorm lookup
1101932Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
77659abe-74be-4092-90fe-cc475726d4ecAvailable 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
31722-230-01DEXMETHYLPHENIDATE HYDROCHLORIDE100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-230-01EA - Each31722-230d7439a11-4e17-42c9-867a-87306bfd6a9112022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-230DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 1 package rows20211224_77659abe-74be-4092-90fe-cc475726d4ec.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
DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceuticals, Inc.77659abe-74be-4092-90fe-cc475726d4ec2021-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215523
application number: ANDA215523
ndc (product): 31722-230

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
899439dexmethylphenidate HCl 10 MG 24HR Extended Release Oral CapsulePSN77659abe-74be-4092-90fe-cc475726d4ec1
899461dexmethylphenidate HCl 15 MG 24HR Extended Release Oral CapsulePSN77659abe-74be-4092-90fe-cc475726d4ec1
899485dexmethylphenidate HCl 20 MG 24HR Extended Release Oral CapsulePSN77659abe-74be-4092-90fe-cc475726d4ec1
1101926dexmethylphenidate HCl 25 MG 24HR Extended Release Oral CapsulePSN77659abe-74be-4092-90fe-cc475726d4ec1
899495dexmethylphenidate HCl 30 MG 24HR Extended Release Oral CapsulePSN77659abe-74be-4092-90fe-cc475726d4ec1
1101932dexmethylphenidate HCl 35 MG 24HR Extended Release Oral CapsulePSN77659abe-74be-4092-90fe-cc475726d4ec1
1006608dexmethylphenidate HCl 40 MG 24HR Extended Release Oral CapsulePSN77659abe-74be-4092-90fe-cc475726d4ec1
899511dexmethylphenidate HCl 5 MG 24HR Extended Release Oral CapsulePSN77659abe-74be-4092-90fe-cc475726d4ec1
89943924 HR dexmethylphenidate hydrochloride 10 MG Extended Release Oral CapsuleSCD77659abe-74be-4092-90fe-cc475726d4ec1
89946124 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral CapsuleSCD77659abe-74be-4092-90fe-cc475726d4ec1
89948524 HR dexmethylphenidate hydrochloride 20 MG Extended Release Oral CapsuleSCD77659abe-74be-4092-90fe-cc475726d4ec1
110192624 HR dexmethylphenidate hydrochloride 25 MG Extended Release Oral CapsuleSCD77659abe-74be-4092-90fe-cc475726d4ec1
89949524 HR dexmethylphenidate hydrochloride 30 MG Extended Release Oral CapsuleSCD77659abe-74be-4092-90fe-cc475726d4ec1
110193224 HR dexmethylphenidate hydrochloride 35 MG Extended Release Oral CapsuleSCD77659abe-74be-4092-90fe-cc475726d4ec1
100660824 HR dexmethylphenidate hydrochloride 40 MG Extended Release Oral CapsuleSCD77659abe-74be-4092-90fe-cc475726d4ec1
89951124 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral CapsuleSCD77659abe-74be-4092-90fe-cc475726d4ec1
899439dexmethylphenidate hydrochloride 10 MG 24 HR Extended Release Oral CapsuleSY77659abe-74be-4092-90fe-cc475726d4ec1
899461dexmethylphenidate hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSY77659abe-74be-4092-90fe-cc475726d4ec1
899485dexmethylphenidate hydrochloride 20 MG 24 HR Extended Release Oral CapsuleSY77659abe-74be-4092-90fe-cc475726d4ec1
1101926dexmethylphenidate hydrochloride 25 MG 24 HR Extended Release Oral CapsuleSY77659abe-74be-4092-90fe-cc475726d4ec1
899495dexmethylphenidate hydrochloride 30 MG 24 HR Extended Release Oral CapsuleSY77659abe-74be-4092-90fe-cc475726d4ec1
1101932dexmethylphenidate hydrochloride 35 MG 24 HR Extended Release Oral CapsuleSY77659abe-74be-4092-90fe-cc475726d4ec1
1006608dexmethylphenidate hydrochloride 40 MG 24 HR Extended Release Oral CapsuleSY77659abe-74be-4092-90fe-cc475726d4ec1
899511dexmethylphenidate hydrochloride 5 MG 24 HR Extended Release Oral CapsuleSY77659abe-74be-4092-90fe-cc475726d4ec1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-230-0131722023001100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-230-01) 2021-12-080000-00-00NoNoCurrent