Home NDC 0406-1220 Amphetamine Sulfate
Product NDC 0406-1220
11-digit product format 004061220
Labeler code 0406
Product ID 0406-1220_8fdfec51-e7c0-429b-a3f4-8f5ae2679147
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amphetamine Sulfate
Dosage form TABLET
Route ORAL
Labeler SpecGx LLC
Application ANDA213583
Marketing category ANDA
Marketing start 2021-02-28
Substance AMPHETAMINE SULFATE
Active strength 10 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 A213583-001 AMPHETAMINE SULFATE AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2021-01-22 A213583-002 AMPHETAMINE SULFATE AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2021-01-22
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 · 70 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 A213583-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2021-01-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213583-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2021-01-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213583-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2021-01-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213583-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2021-01-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213583-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2021-01-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213583-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2021-01-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213583-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2021-01-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213583-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2021-01-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213583-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2021-01-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213583-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2021-01-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213583-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2021-01-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213583-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2021-01-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213583-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2021-01-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213583-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2021-01-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213583-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2021-01-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213583-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2021-01-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213583-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2021-01-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213583-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2021-01-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213583-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2021-01-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213583-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2021-01-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213583-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2021-01-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213583-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2021-01-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213583-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2021-01-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213583-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2021-01-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213583-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2021-01-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213583-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2021-01-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213583-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2021-01-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A213583-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2021-01-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213583-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2021-01-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213583-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2021-01-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213583-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2021-01-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A213583-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2021-01-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213583-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2021-01-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A213583-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2021-01-22 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213583-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2021-01-22 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A213583-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2021-01-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213583-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2021-01-22 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A213583-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2021-01-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213583-001 AMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2021-01-22 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213583-002 AMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2021-01-22 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 70 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 10 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 884655 Internal RxNorm lookup 1600695 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 0406-1220-01 Amphetamine Sulfate 100 in 1 BOTTLE TABLET 100 10
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 0406-1220-01 00406122001 100 TABLET in 1 BOTTLE (0406-1220-01) 100 tablet 2021-02-28 0000-00-00 No No Current