FDA.reportPublic FDA data

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate

Product NDC
64850-505
11-digit product format
648500505
Labeler code
64850
Product ID
64850-505_b65e0266-7172-4730-8f93-eb42e08fb7b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Elite Laboratories, Inc.
Application
ANDA211352
Marketing category
ANDA
Marketing start
2022-12-29
Substance
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Active strength
5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], 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
A211352-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALAB2018-12-07
A211352-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE1.875MG;1.875MG;1.875MG;1.875MGTABLET / ORALAB2018-12-07
A211352-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALAB2018-12-07
A211352-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE3.125MG;3.125MG;3.125MG;3.125MGTABLET / ORALAB2018-12-07
A211352-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALAB2018-12-07
A211352-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE5MG;5MG;5MG;5MGTABLET / ORALAB2018-12-07
A211352-007DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE7.5MG;7.5MG;7.5MG;7.5MGTABLET / ORALAB2018-12-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211352-001AB
A211352-002AB
A211352-003AB
A211352-004AB
A211352-005AB
A211352-006AB
A211352-007AB

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 22:54:322026-06A211352-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALAB2018-12-07a50c72e98297…
2026-08-01 22:54:322026-06A211352-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.875MG;1.875MG;1.875MG;1.875MGTABLET / ORALAB2018-12-07a50c72e98297…
2026-08-01 22:54:322026-06A211352-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALAB2018-12-07a50c72e98297…
2026-08-01 22:54:322026-06A211352-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.125MG;3.125MG;3.125MG;3.125MGTABLET / ORALAB2018-12-07a50c72e98297…
2026-08-01 22:54:322026-06A211352-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALAB2018-12-07a50c72e98297…
2026-08-01 22:54:322026-06A211352-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGTABLET / ORALAB2018-12-07a50c72e98297…
2026-08-01 22:54:322026-06A211352-007DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGTABLET / ORALAB2018-12-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A211352-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A211352-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A211352-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A211352-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A211352-005AB1a50c72e98297…
2026-08-01 22:54:322026-06A211352-006AB1a50c72e98297…
2026-08-01 22:54:322026-06A211352-007AB1a50c72e98297…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATEElite Laboratories, Inc.e677690f-790f-4626-ad78-097cdb6ea5402026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211352
application number: ANDA211352
ndc (product): 64850-505
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATEBryant Ranch Prepack74cda9cf-e1c1-4297-b7df-eee08aaf0ae72023-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211352
application number: ANDA211352
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATEBryant Ranch Prepack35900892-086e-43e4-9f58-279e4af868452023-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211352
application number: ANDA211352
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATEBryant Ranch Prepack55da4af2-9765-4e75-ba0d-c1ec6e36de332023-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211352
application number: ANDA211352
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATEBryant Ranch Prepack095f7c39-2685-483a-9d90-47a1398b9dc92023-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211352
application number: ANDA211352
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATEBryant Ranch Prepackaa87c385-8e6f-49d5-951c-0c9f4ee1042e2023-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211352
application number: ANDA211352
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATEBryant Ranch Prepack7c3885dc-c094-4378-b814-986a673c7e922023-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211352
application number: ANDA211352
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATEBryant Ranch Prepack4cc0104f-c00a-4486-966e-5bc89a5ce0452023-07-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211352
application number: ANDA211352

Additional Listing Data#

Finished product
Yes
Brand name base
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROAMPHETAMINE SACCHARATE5 mg/1
AMPHETAMINE ASPARTATE MONOHYDRATE5 mg/1
DEXTROAMPHETAMINE SULFATE5 mg/1
AMPHETAMINE SULFATE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G83415V073Internal UNII lookup
JJ768O327NInternal UNII lookup
O1ZPV620O4Internal UNII lookup
6DPV8NK46SInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
541363Internal RxNorm lookup
541878Internal RxNorm lookup
541892Internal RxNorm lookup
577957Internal RxNorm lookup
577961Internal RxNorm lookup
687043Internal RxNorm lookup
1009145Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e677690f-790f-4626-ad78-097cdb6ea540Available 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
8b92ab59-8b26-4c89-a2d6-8d5140526ec6Product name320231213
b4c312b9-fad5-247e-cef9-87a74220463dProduct name520230426
8170729e-5ba4-46f9-830f-5f0fae5942ceProduct name120230103
4496d022-9224-4ee0-943a-50fbe6cd7123Product name220220901
2a7aa275-a4ca-44eb-971f-47427a374085Product name920220615
93730fbf-8b45-4623-b27d-cf03825d04b3Product name520220314
aa1b3c66-c4f6-78f2-abd3-31cc9d555e27Product name520190913
b4c312b9-fad5-247e-cef9-87a74220463dProduct name420171211
57953747-955c-4dd8-9164-49d8ea877eaeProduct name120171113
fcc7ea58-a369-4e91-b092-5cde9ac2669fProduct name120160224
ffdf7f68-0f44-4dd6-a026-336dcb345fc4Product name120151109

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64850-505-01Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate100 in 1 BOTTLETABLET10010
64850-505-05Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate500 in 1 BOTTLETABLET50010
64850-505-30Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate30 in 1 BOTTLETABLET3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64850-505-01EA - Each64850-50573bc04a5-8e99-48d7-8e05-45eb638dba1012023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64850-505DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [ELITE LABORATORIES, INC.]10Current NDC, Legacy NDC, 3 package rows20231020_e677690f-790f-4626-ad78-097cdb6ea540.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577961dextroamphetamine saccharate 5 MG / amphetamine aspartate 5 MG / dextroamphetamine sulfate 5 MG / amphetamine sulfate 5 MG Oral TabletPSNaa87c385-8e6f-49d5-951c-0c9f4ee1042e101
577961amphetamine aspartate 5 MG / amphetamine sulfate 5 MG / dextroamphetamine saccharate 5 MG / dextroamphetamine sulfate 5 MG Oral TabletSCDaa87c385-8e6f-49d5-951c-0c9f4ee1042e101
577961mixed amphetamine salts 20 MG Oral TabletSYaa87c385-8e6f-49d5-951c-0c9f4ee1042e101
541878dextroamphetamine saccharate 1.25 MG / amphetamine aspartate 1.25 MG / dextroamphetamine sulfate 1.25 MG / amphetamine sulfate 1.25 MG Oral TabletPSNe677690f-790f-4626-ad78-097cdb6ea54010
1009145dextroamphetamine saccharate 1.875 MG / amphetamine aspartate 1.875 MG / dextroamphetamine sulfate 1.875 MG / amphetamine sulfate 1.875 MG Oral TabletPSNe677690f-790f-4626-ad78-097cdb6ea54010
541892dextroamphetamine saccharate 2.5 MG / amphetamine aspartate 2.5 MG / dextroamphetamine sulfate 2.5 MG / amphetamine sulfate 2.5 MG Oral TabletPSNe677690f-790f-4626-ad78-097cdb6ea54010
687043dextroamphetamine saccharate 3.125 MG / amphetamine aspartate 3.125 MG / dextroamphetamine sulfate 3.125 MG / amphetamine sulfate 3.125 MG Oral TabletPSNe677690f-790f-4626-ad78-097cdb6ea54010
577957dextroamphetamine saccharate 3.75 MG / amphetamine aspartate 3.75 MG / dextroamphetamine sulfate 3.75 MG / amphetamine sulfate 3.75 MG Oral TabletPSNe677690f-790f-4626-ad78-097cdb6ea54010
577961dextroamphetamine saccharate 5 MG / amphetamine aspartate 5 MG / dextroamphetamine sulfate 5 MG / amphetamine sulfate 5 MG Oral TabletPSNe677690f-790f-4626-ad78-097cdb6ea54010
541363dextroamphetamine saccharate 7.5 MG / amphetamine aspartate 7.5 MG / dextroamphetamine sulfate 7.5 MG / amphetamine sulfate 7.5 MG Oral TabletPSNe677690f-790f-4626-ad78-097cdb6ea54010
541878amphetamine aspartate 1.25 MG / amphetamine sulfate 1.25 MG / dextroamphetamine saccharate 1.25 MG / dextroamphetamine sulfate 1.25 MG Oral TabletSCDe677690f-790f-4626-ad78-097cdb6ea54010
1009145amphetamine aspartate 1.875 MG / amphetamine sulfate 1.875 MG / dextroamphetamine saccharate 1.875 MG / dextroamphetamine sulfate 1.875 MG Oral TabletSCDe677690f-790f-4626-ad78-097cdb6ea54010
541892amphetamine aspartate 2.5 MG / amphetamine sulfate 2.5 MG / dextroamphetamine saccharate 2.5 MG / dextroamphetamine sulfate 2.5 MG Oral TabletSCDe677690f-790f-4626-ad78-097cdb6ea54010
687043amphetamine aspartate 3.125 MG / amphetamine sulfate 3.125 MG / dextroamphetamine saccharate 3.125 MG / dextroamphetamine sulfate 3.125 MG Oral TabletSCDe677690f-790f-4626-ad78-097cdb6ea54010
577957amphetamine aspartate 3.75 MG / amphetamine sulfate 3.75 MG / dextroamphetamine saccharate 3.75 MG / dextroamphetamine sulfate 3.75 MG Oral TabletSCDe677690f-790f-4626-ad78-097cdb6ea54010
577961amphetamine aspartate 5 MG / amphetamine sulfate 5 MG / dextroamphetamine saccharate 5 MG / dextroamphetamine sulfate 5 MG Oral TabletSCDe677690f-790f-4626-ad78-097cdb6ea54010
541363amphetamine aspartate 7.5 MG / amphetamine sulfate 7.5 MG / dextroamphetamine saccharate 7.5 MG / dextroamphetamine sulfate 7.5 MG Oral TabletSCDe677690f-790f-4626-ad78-097cdb6ea54010
541892mixed amphetamine salts 10 MG Oral TabletSYe677690f-790f-4626-ad78-097cdb6ea54010
687043mixed amphetamine salts 12.5 MG Oral TabletSYe677690f-790f-4626-ad78-097cdb6ea54010
577957mixed amphetamine salts 15 MG Oral TabletSYe677690f-790f-4626-ad78-097cdb6ea54010
577961mixed amphetamine salts 20 MG Oral TabletSYe677690f-790f-4626-ad78-097cdb6ea54010
541363mixed amphetamine salts 30 MG Oral TabletSYe677690f-790f-4626-ad78-097cdb6ea54010
541878mixed amphetamine salts 5 MG Oral TabletSYe677690f-790f-4626-ad78-097cdb6ea54010
1009145mixed amphetamine salts 7.5 MG Oral TabletSYe677690f-790f-4626-ad78-097cdb6ea54010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64850-505-0164850050501100 TABLET in 1 BOTTLE (64850-505-01) 100 tablet2022-12-290000-00-00NoNoCurrent
64850-505-0564850050505500 TABLET in 1 BOTTLE (64850-505-05) 500 tablet2022-12-290000-00-00NoNoCurrent
64850-505-306485005053030 TABLET in 1 BOTTLE (64850-505-30) 30 tablet2022-12-290000-00-00NoNoCurrent