Home NDC 13107-035 DEXTROAMPHETAMINE SULFATE
Product NDC 13107-035
11-digit product format 131070035
Labeler code 13107
Product ID 13107-035_a0c002da-f6e9-4979-af9b-5ca20118bc43
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DEXTROAMPHETAMINE SULFATE
Dosage form TABLET
Route ORAL
Labeler Aurolife Pharma, LLC
Application ANDA202893
Marketing category ANDA
Marketing start 2013-07-31
Substance DEXTROAMPHETAMINE SULFATE
Active strength 5 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202893-001 DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2013-07-31 A202893-002 DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2013-07-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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.
Product history page 1 of 3 · 82 observed 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 2026-02-19 14:30 UTC 2026-02 A202893-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2013-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202893-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2013-07-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202893-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2013-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202893-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2013-07-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202893-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2013-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202893-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2013-07-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202893-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2013-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202893-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2013-07-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202893-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2013-07-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202893-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2013-07-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202893-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2013-07-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202893-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2013-07-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202893-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2013-07-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202893-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2013-07-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202893-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2013-07-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202893-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2013-07-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202893-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2013-07-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202893-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2013-07-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202893-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2013-07-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202893-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2013-07-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202893-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2013-07-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202893-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2013-07-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202893-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2013-07-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202893-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2013-07-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202893-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2013-07-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202893-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2013-07-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202893-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2013-07-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202893-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2013-07-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202893-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2013-07-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202893-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2013-07-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202893-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2013-07-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202893-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2013-07-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202893-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2013-07-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202893-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2013-07-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202893-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2013-07-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202893-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2013-07-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202893-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2013-07-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A202893-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2013-07-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202893-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2013-07-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A202893-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2013-07-31 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base DEXTROAMPHETAMINE SULFATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROAMPHETAMINE SULFATE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination JJ768O327N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 884385 Internal RxNorm lookup 884386 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 13107-035-01 DEXTROAMPHETAMINE SULFATE 100 in 1 BOTTLE TABLET 100 13 13107-035-50 DEXTROAMPHETAMINE SULFATE 50 in 1 BOTTLE TABLET 50 13 13107-035-99 DEXTROAMPHETAMINE SULFATE 1000 in 1 BOTTLE TABLET 1000 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROAMPHETAMINE SULFATE ACTIVE INGREDIENT JJ768O327N DEXTROAMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 2 DEXTROAMPHETAMINE ACTIVE MOIETY TZ47U051FI DEXTROAMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DEXTROAMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DEXTROAMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DEXTROAMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DEXTROAMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DEXTROAMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DEXTROAMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13107-035 DEXTROAMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 13 Current NDC, Legacy NDC, 3 package rows 20240702_24163442-dd03-4066-a6ed-eb7e292b700b.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.
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 13107-035-01 13107003501 100 TABLET in 1 BOTTLE (13107-035-01) 100 tablet 2013-07-31 0000-00-00 No No Current 13107-035-50 13107003550 50 TABLET in 1 BOTTLE (13107-035-50) 50 tablet 2013-07-31 0000-00-00 No No Current 13107-035-99 13107003599 1000 TABLET in 1 BOTTLE (13107-035-99) 1000 tablet 2013-07-31 0000-00-00 No No Current