FDA.reportPublic FDA data

Dextroamphetamine Sulfate

Product NDC
75826-126
Requested package NDC
75826-126-30
11-digit product format
758260126
Labeler code
75826
Product ID
75826-126_37ddfa9e-e495-a25f-e063-6394a90ac3d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextroamphetamine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Winder Laboratories LLC
Application
ANDA212160
Marketing category
ANDA
Marketing start
2021-12-06
Substance
DEXTROAMPHETAMINE SULFATE
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
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 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212160-001DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE2.5MGTABLET / ORALAA2021-06-07
A212160-002DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE5MGTABLET / ORALAA2021-06-07
A212160-003DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE7.5MGTABLET / ORALAA2021-06-07
A212160-004DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE10MGTABLET / ORALAA2021-06-07
A212160-005DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE15MGTABLET / ORALAA2021-06-07
A212160-006DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE20MGTABLET / ORALAA2021-06-07
A212160-007DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE30MGTABLET / ORALAA2021-06-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-productTE code
A212160-001AA
A212160-002AA
A212160-003AA
A212160-004AA
A212160-005AA
A212160-006AA
A212160-007AA

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 22:54:322026-06A212160-001DEXTROAMPHETAMINE SULFATE2.5MGTABLET / ORALAA2021-06-07a50c72e98297…
2026-08-01 22:54:322026-06A212160-002DEXTROAMPHETAMINE SULFATE5MGTABLET / ORALAA2021-06-07a50c72e98297…
2026-08-01 22:54:322026-06A212160-003DEXTROAMPHETAMINE SULFATE7.5MGTABLET / ORALAA2021-06-07a50c72e98297…
2026-08-01 22:54:322026-06A212160-004DEXTROAMPHETAMINE SULFATE10MGTABLET / ORALAA2021-06-07a50c72e98297…
2026-08-01 22:54:322026-06A212160-005DEXTROAMPHETAMINE SULFATE15MGTABLET / ORALAA2021-06-07a50c72e98297…
2026-08-01 22:54:322026-06A212160-006DEXTROAMPHETAMINE SULFATE20MGTABLET / ORALAA2021-06-07a50c72e98297…
2026-08-01 22:54:322026-06A212160-007DEXTROAMPHETAMINE SULFATE30MGTABLET / ORALAA2021-06-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A212160-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A212160-002AA1a50c72e98297…
2026-08-01 22:54:322026-06A212160-003AA1a50c72e98297…
2026-08-01 22:54:322026-06A212160-004AA1a50c72e98297…
2026-08-01 22:54:322026-06A212160-005AA1a50c72e98297…
2026-08-01 22:54:322026-06A212160-006AA1a50c72e98297…
2026-08-01 22:54:322026-06A212160-007AA1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dextroamphetamine SulfateDEXTROAMPHETAMINE SULFATEWinder Laboratories LLCca1a8890-0675-4c9c-9716-6c28f975d8272025-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212160
application number: ANDA212160
ndc (package): 75826-126-30
ndc (product): 75826-126
ndc11 (package): 75826012630

Additional Listing Data#

Finished product
Yes
Brand name base
Dextroamphetamine Sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROAMPHETAMINE SULFATE30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JJ768O327NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
884385Internal RxNorm lookup
884386Internal RxNorm lookup
884684Internal RxNorm lookup
1425847Internal RxNorm lookup
1425854Internal RxNorm lookup
1535454Internal RxNorm lookup
1535470Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ca1a8890-0675-4c9c-9716-6c28f975d827Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0f66b30d-6b15-4b2d-91a5-1531b9bb6d21Product name720250625
917bdf48-c3f5-4a58-ac8e-d2d94a9c1e2bProduct name220250616
b4c312b9-fad5-247e-cef9-87a74220463dProduct name520230426
8170729e-5ba4-46f9-830f-5f0fae5942ceProduct name120230103
2a7aa275-a4ca-44eb-971f-47427a374085Product name920220615
aa1b3c66-c4f6-78f2-abd3-31cc9d555e27Product name520190913
b4c312b9-fad5-247e-cef9-87a74220463dProduct name420171211
ffdf7f68-0f44-4dd6-a026-336dcb345fc4Product name120151109

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75826-126-10Dextroamphetamine Sulfate100 in 1 BOTTLE, PLASTICTABLET10011
75826-126-30Dextroamphetamine Sulfate30 in 1 BOTTLE, PLASTICTABLET3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75826-126-10EA - Each75826-126d38f1459-77af-4a97-b548-63c6b698c93012024-01-04
75826-126-30EA - Each75826-1266ff25a14-fc0f-40e4-9677-2c3619007d2712024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75826-126DEXTROAMPHETAMINE SULFATE TABLET [WINDER LABORATORIES LLC]10Current NDC, Legacy NDC, 2 package rows20240814_ca1a8890-0675-4c9c-9716-6c28f975d827.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884385dextroamphetamine sulfate 10 MG Oral TabletPSNca1a8890-0675-4c9c-9716-6c28f975d82711
884684dextroamphetamine sulfate 15 MG Oral TabletPSNca1a8890-0675-4c9c-9716-6c28f975d82711
1425847dextroamphetamine sulfate 2.5 MG Oral TabletPSNca1a8890-0675-4c9c-9716-6c28f975d82711
1535454dextroamphetamine sulfate 20 MG Oral TabletPSNca1a8890-0675-4c9c-9716-6c28f975d82711
1535470dextroamphetamine sulfate 30 MG Oral TabletPSNca1a8890-0675-4c9c-9716-6c28f975d82711
884386dextroamphetamine sulfate 5 MG Oral TabletPSNca1a8890-0675-4c9c-9716-6c28f975d82711
1425854dextroamphetamine sulfate 7.5 MG Oral TabletPSNca1a8890-0675-4c9c-9716-6c28f975d82711
884385dextroamphetamine sulfate 10 MG Oral TabletSCDca1a8890-0675-4c9c-9716-6c28f975d82711
884684dextroamphetamine sulfate 15 MG Oral TabletSCDca1a8890-0675-4c9c-9716-6c28f975d82711
1425847dextroamphetamine sulfate 2.5 MG Oral TabletSCDca1a8890-0675-4c9c-9716-6c28f975d82711
1535454dextroamphetamine sulfate 20 MG Oral TabletSCDca1a8890-0675-4c9c-9716-6c28f975d82711
1535470dextroamphetamine sulfate 30 MG Oral TabletSCDca1a8890-0675-4c9c-9716-6c28f975d82711
884386dextroamphetamine sulfate 5 MG Oral TabletSCDca1a8890-0675-4c9c-9716-6c28f975d82711
1425854dextroamphetamine sulfate 7.5 MG Oral TabletSCDca1a8890-0675-4c9c-9716-6c28f975d82711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75826-126-307582601263030 TABLET in 1 BOTTLE, PLASTIC (75826-126-30) 30 tablet2023-03-240000-00-00NoNoCurrent