Home NDC 0555-0952 Dextroamphetamine Sulfate
Product NDC 0555-0952
11-digit product format 005550952
Labeler code 0555
Product ID 0555-0952_05934bca-3ed9-4ce3-ba1d-2063930aad63
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dextroamphetamine Sulfate
Dosage form TABLET
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA040361
Marketing category ANDA
Marketing start 2001-02-12
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 2027-12-31
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 A040361-001 DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2001-01-31 A040361-002 DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA RS 2001-01-31
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 A040361-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2001-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040361-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA RS 2001-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040361-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2001-01-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040361-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA RS 2001-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040361-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2001-01-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040361-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA RS 2001-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040361-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2001-01-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040361-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA RS 2001-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040361-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2001-01-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040361-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA RS 2001-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040361-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2001-01-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040361-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA RS 2001-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040361-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2001-01-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040361-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA RS 2001-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040361-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2001-01-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040361-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA RS 2001-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040361-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2001-01-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040361-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA RS 2001-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040361-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2001-01-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040361-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA RS 2001-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040361-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2001-01-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040361-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA RS 2001-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040361-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2001-01-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040361-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA RS 2001-01-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040361-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2001-01-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040361-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA RS 2001-01-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040361-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2001-01-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040361-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA RS 2001-01-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040361-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2001-01-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040361-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA RS 2001-01-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040361-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2001-01-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040361-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA RS 2001-01-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040361-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2001-01-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040361-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA RS 2001-01-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040361-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2001-01-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040361-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA RS 2001-01-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040361-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2001-01-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040361-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA RS 2001-01-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040361-001 DEXTROAMPHETAMINE SULFATE 5MG TABLET / ORAL AA 2001-01-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A040361-002 DEXTROAMPHETAMINE SULFATE 10MG TABLET / ORAL AA RS 2001-01-31 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 2027-12-31 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0555-0952-02 Dextroamphetamine Sulfate 100 in 1 BOTTLE TABLET 100 22
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0555-0952 DEXTROAMPHETAMINE SULFATE TABLET [TEVA PHARMACEUTICALS USA, INC.] 21 Current NDC, Legacy NDC, 1 package rows 20231016_ec2d13f3-d14f-47e4-abe9-7763f95a8e94.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 0555-0952-02 00555095202 100 TABLET in 1 BOTTLE (0555-0952-02) 100 tablet 2001-02-12 0000-00-00 No No Current