Home NDC 72162-1233 DEXTROAMPHETAMINE SULFATE
Product NDC 72162-1233
11-digit product format 721621233
Labeler code 72162
Product ID 72162-1233_b98dbd7a-41a8-40ab-bab6-769dcb663abe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dextroamphetamine sulfate
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA210059
Marketing category ANDA
Marketing start 2018-07-04
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 42 .
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 A210059-001 DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2017-10-18 A210059-002 DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2017-10-18
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 · 84 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 2026-08-18 06:07:40 2026-07 A210059-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2017-10-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210059-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2017-10-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210059-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2017-10-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210059-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2017-10-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210059-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2017-10-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210059-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2017-10-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210059-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2017-10-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210059-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2017-10-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210059-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2017-10-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210059-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2017-10-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210059-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2017-10-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210059-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2017-10-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210059-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2017-10-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210059-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2017-10-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210059-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2017-10-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210059-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2017-10-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210059-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2017-10-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210059-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2017-10-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210059-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2017-10-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210059-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2017-10-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210059-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2017-10-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210059-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2017-10-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210059-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2017-10-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210059-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2017-10-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210059-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2017-10-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210059-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2017-10-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210059-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2017-10-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210059-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2017-10-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210059-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2017-10-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210059-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2017-10-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210059-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2017-10-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210059-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2017-10-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210059-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2017-10-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A210059-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2017-10-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210059-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2017-10-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A210059-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2017-10-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210059-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2017-10-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A210059-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2017-10-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210059-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2017-10-18 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A210059-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2017-10-18 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 884386 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 72162-1233-1 DEXTROAMPHETAMINE SULFATE 100 in 1 BOTTLE TABLET 100 103 72162-1233-3 DEXTROAMPHETAMINE SULFATE 30 in 1 BOTTLE TABLET 30 103
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72162-1233 DEXTROAMPHETAMINE SULFATE TABLET [BRYANT RANCH PREPACK] 103 Current NDC, 2 package rows 20240919_5c493bef-0c3e-49f5-b55a-f1446094f5da.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE SUNRISE PHARMACEUTICAL, INC. 93b3a40f-b7ac-4047-8ff5-3e34c2d75193 2026-08-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210059 application number: ANDA210059 DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE Bryant Ranch Prepack 466cbae8-4f67-4a65-b670-ada6a953d550 2025-01-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210059 application number: ANDA210059 DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE Bryant Ranch Prepack 0ef920a9-c5b9-4d31-a478-ee18d22a3c5b 2025-01-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210059 application number: ANDA210059 DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE Bryant Ranch Prepack c706a849-9df6-43ca-9ac6-1d9ce6b8e855 2024-09-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210059 application number: ANDA210059 DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE Bryant Ranch Prepack 5c493bef-0c3e-49f5-b55a-f1446094f5da 2024-09-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210059 application number: ANDA210059 ndc (product): 72162-1233
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72162-1233-1 72162123301 100 TABLET in 1 BOTTLE (72162-1233-1) 100 tablet 2024-09-06 No No Current 72162-1233-3 72162123303 30 TABLET in 1 BOTTLE (72162-1233-3) 30 tablet 2024-09-06 No No Current