Home NDC 43386-871 Dextroamphetamine Sulfate
Product NDC 43386-871
11-digit product format 433860871
Labeler code 43386
Product ID 43386-871_fe1d7b03-a5d0-4a7c-99ad-7aca6edb5d02
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dextroamphetamine sulfate
Dosage form TABLET
Route ORAL
Labeler Lupin Pharmaceuticals,Inc.
Application ANDA204330
Marketing category ANDA
Marketing start 2016-04-25
Substance DEXTROAMPHETAMINE 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 A204330-001 DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2016-03-16 A204330-002 DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2016-03-16
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 A204330-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2016-03-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204330-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2016-03-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204330-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2016-03-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204330-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2016-03-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204330-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2016-03-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204330-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2016-03-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204330-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2016-03-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204330-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2016-03-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204330-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2016-03-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204330-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2016-03-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204330-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2016-03-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204330-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2016-03-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204330-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2016-03-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204330-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2016-03-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204330-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2016-03-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204330-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2016-03-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204330-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2016-03-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204330-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2016-03-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204330-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2016-03-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204330-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2016-03-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204330-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2016-03-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204330-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2016-03-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204330-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2016-03-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204330-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2016-03-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204330-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2016-03-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204330-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2016-03-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204330-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2016-03-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204330-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2016-03-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204330-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2016-03-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204330-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2016-03-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204330-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2016-03-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A204330-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2016-03-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204330-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2016-03-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A204330-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2016-03-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204330-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2016-03-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A204330-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2016-03-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204330-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2016-03-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A204330-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2016-03-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204330-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2016-03-16 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A204330-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA 2016-03-16 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 10 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43386-871-01 Dextroamphetamine Sulfate 100 in 1 BOTTLE TABLET 100 7 43386-871-03 Dextroamphetamine Sulfate 30 in 1 BOTTLE TABLET 30 7 43386-871-10 Dextroamphetamine Sulfate 1000 in 1 BOTTLE TABLET 1000 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43386-871 DEXTROAMPHETAMINE SULFATE TABLET [LUPIN PHARMACEUTICALS,INC.] 7 Current NDC, Legacy NDC, 3 package rows 20240131_9aea6b7c-729c-484d-b625-c3591b63b350.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 43386-871-01 43386087101 100 TABLET in 1 BOTTLE (43386-871-01) 100 tablet 2016-04-25 0000-00-00 No No Current 43386-871-03 43386087103 30 TABLET in 1 BOTTLE (43386-871-03) 30 tablet 2016-04-25 0000-00-00 No No Current 43386-871-10 43386087110 1000 TABLET in 1 BOTTLE (43386-871-10) 1000 tablet 2016-04-25 0000-00-00 No No Current