Home NDC 72162-1368 AMPHETAMINE SULFATE
Product NDC 72162-1368
11-digit product format 721621368
Labeler code 72162
Product ID 72162-1368_331b5d38-2495-4096-9eab-ca7396274271
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amphetamine sulfate
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA211861
Marketing category ANDA
Marketing start 2020-04-02
Substance AMPHETAMINE 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 A211861-001 AMPHETAMINE SULFATE AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2020-03-11 A211861-002 AMPHETAMINE SULFATE AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2020-03-11
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 2 · 74 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 A211861-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2020-03-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211861-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2020-03-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211861-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2020-03-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211861-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2020-03-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211861-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2020-03-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211861-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2020-03-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211861-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2020-03-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211861-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2020-03-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211861-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2020-03-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211861-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2020-03-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211861-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2020-03-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211861-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2020-03-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211861-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2020-03-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211861-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2020-03-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211861-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2020-03-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211861-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2020-03-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211861-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2020-03-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211861-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2020-03-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211861-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2020-03-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211861-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2020-03-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211861-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2020-03-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211861-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2020-03-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211861-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2020-03-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211861-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2020-03-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211861-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2020-03-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211861-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2020-03-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211861-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2020-03-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211861-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2020-03-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211861-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2020-03-11 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211861-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2020-03-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211861-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2020-03-11 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A211861-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2020-03-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211861-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2020-03-11 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A211861-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2020-03-11 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211861-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2020-03-11 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A211861-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2020-03-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211861-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2020-03-11 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A211861-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2020-03-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211861-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2020-03-11 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211861-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2020-03-11 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 74 observed states.
Additional Listing Data#
Finished product Yes
Brand name base AMPHETAMINE SULFATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMPHETAMINE 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 6DPV8NK46S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 884655 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 72162-1368-1 AMPHETAMINE SULFATE 100 in 1 BOTTLE TABLET 100 100
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72162-1368 AMPHETAMINE SULFATE TABLET [BRYANT RANCH PREPACK] 100 Current NDC, 1 package rows 20240126_ad4ce013-331b-4359-898f-bac97d64874f.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join AMPHETAMINE SULFATE AMPHETAMINE SULFATE Solco Healthcare US, LLC 89c5b52f-3c2a-41d5-8624-9ee51c512c72 2025-05-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211861 application number: ANDA211861 AMPHETAMINE SULFATE AMPHETAMINE SULFATE Bryant Ranch Prepack ad4ce013-331b-4359-898f-bac97d64874f 2024-01-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211861 application number: ANDA211861 ndc (product): 72162-1368 AMPHETAMINE SULFATE AMPHETAMINE SULFATE Bryant Ranch Prepack 7f16dd18-bf30-41ef-8981-932da5df0951 2024-01-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211861 application number: ANDA211861 AMPHETAMINE SULFATE AMPHETAMINE SULFATE Bryant Ranch Prepack 8f9341fc-4b95-4556-a51a-ea972fa6fccc 2024-01-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211861 application number: ANDA211861
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72162-1368-1 72162136801 100 TABLET in 1 BOTTLE (72162-1368-1) 100 tablet 2024-01-25 No No Current