Home NDC 13107-074 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Product NDC 13107-074
11-digit product format 131070074
Labeler code 13107
Product ID 13107-074_5962d880-9f18-4a57-8c95-ca0ec1e86f44
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Dosage form TABLET
Route ORAL
Labeler Aurolife Pharma, LLC
Application ANDA202424
Marketing category ANDA
Marketing start 2013-11-27
Substance AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Active strength 7.5; 7.5; 7.5; 7.5 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202424-001 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.25MG;1.25MG;1.25MG;1.25MG TABLET / ORAL AB 2013-11-27 A202424-002 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.875MG;1.875MG;1.875MG;1.875MG TABLET / ORAL AB 2013-11-27 A202424-003 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 2.5MG;2.5MG;2.5MG;2.5MG TABLET / ORAL AB 2013-11-27 A202424-004 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.125MG;3.125MG;3.125MG;3.125MG TABLET / ORAL AB 2013-11-27 A202424-005 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.75MG;3.75MG;3.75MG;3.75MG TABLET / ORAL AB 2013-11-27 A202424-006 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 5MG;5MG;5MG;5MG TABLET / ORAL AB 2013-11-27 A202424-007 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 7.5MG;7.5MG;7.5MG;7.5MG TABLET / ORAL AB 2013-11-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 7 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A202424-001 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE 1.25MG;1.25MG;1.25MG;1.25MG TABLET / ORAL AB 2013-11-27 a50c72e98297…2026-08-01 22:54:32 2026-06 A202424-002 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE 1.875MG;1.875MG;1.875MG;1.875MG TABLET / ORAL AB 2013-11-27 a50c72e98297…2026-08-01 22:54:32 2026-06 A202424-003 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE 2.5MG;2.5MG;2.5MG;2.5MG TABLET / ORAL AB 2013-11-27 a50c72e98297…2026-08-01 22:54:32 2026-06 A202424-004 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE 3.125MG;3.125MG;3.125MG;3.125MG TABLET / ORAL AB 2013-11-27 a50c72e98297…2026-08-01 22:54:32 2026-06 A202424-005 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE 3.75MG;3.75MG;3.75MG;3.75MG TABLET / ORAL AB 2013-11-27 a50c72e98297…2026-08-01 22:54:32 2026-06 A202424-006 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE 5MG;5MG;5MG;5MG TABLET / ORAL AB 2013-11-27 a50c72e98297…2026-08-01 22:54:32 2026-06 A202424-007 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE 7.5MG;7.5MG;7.5MG;7.5MG TABLET / ORAL AB 2013-11-27 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Bryant Ranch Prepack ff1e5518-0aa6-4bc9-bc87-8a6a124bc95a 2026-06-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202424 application number: ANDA202424 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE NorthStar RxLLC 8468623b-9584-43ef-ac16-fc15b060624c 2025-12-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202424 application number: ANDA202424 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Aurolife Pharma, LLC a582d57f-d191-4ca5-b105-585b2d8a0e3e 2025-12-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202424 application number: ANDA202424 ndc (product): 13107-074
Additional Listing Data#
Finished product Yes
Brand name base Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROAMPHETAMINE SACCHARATE 7.5 mg/1 AMPHETAMINE ASPARTATE MONOHYDRATE 7.5 mg/1 DEXTROAMPHETAMINE SULFATE 7.5 mg/1 AMPHETAMINE SULFATE 7.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 7 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 541363 Internal RxNorm lookup 541878 Internal RxNorm lookup 541892 Internal RxNorm lookup 577957 Internal RxNorm lookup 577961 Internal RxNorm lookup 687043 Internal RxNorm lookup 1009145 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 13107-074-01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 100 in 1 BOTTLE TABLET 100 14 13107-074-05 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 500 in 1 BOTTLE TABLET 500 14 13107-074-25 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 250 in 1 BOTTLE TABLET 250 14 13107-074-50 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 50 in 1 BOTTLE TABLET 50 14 13107-074-99 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 1000 in 1 BOTTLE TABLET 1000 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMPHETAMINE ASPARTATE MONOHYDRATE ACTIVE INGREDIENT O1ZPV620O4 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 4 AMPHETAMINE SULFATE ACTIVE INGREDIENT 6DPV8NK46S DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 4 DEXTROAMPHETAMINE SACCHARATE ACTIVE INGREDIENT G83415V073 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 4 DEXTROAMPHETAMINE SULFATE ACTIVE INGREDIENT JJ768O327N DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 4 AMPHETAMINE ACTIVE MOIETY CK833KGX7E DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 4 DEXTROAMPHETAMINE ACTIVE MOIETY TZ47U051FI DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 4 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 4 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 4 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 4 POVIDONE INACTIVE INGREDIENT FZ989GH94E DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13107-074 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 13 Current NDC, Legacy NDC, 5 package rows 20250406_a582d57f-d191-4ca5-b105-585b2d8a0e3e.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 13107-074-01 13107007401 100 TABLET in 1 BOTTLE (13107-074-01) 100 tablet 2013-11-27 0000-00-00 No No Current 13107-074-05 13107007405 500 TABLET in 1 BOTTLE (13107-074-05) 500 tablet 2013-11-27 0000-00-00 No No Current 13107-074-25 13107007425 250 TABLET in 1 BOTTLE (13107-074-25) 250 tablet 2013-11-27 0000-00-00 No No Current 13107-074-50 13107007450 50 TABLET in 1 BOTTLE (13107-074-50) 50 tablet 2013-11-27 0000-00-00 No No Current 13107-074-99 13107007499 1000 TABLET in 1 BOTTLE (13107-074-99) 1000 tablet 2013-11-27 0000-00-00 No No Current