Home NDC 13551-701 ProCentra
Product NDC 13551-701
11-digit product format 135510701
Labeler code 13551
Product ID 13551-701_fc4bf594-67d6-4daa-8f7a-efc43a964da4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dextroamphetamine sulfate
Dosage form LIQUID
Route ORAL
Labeler FSC Laboratories, Inc
Application ANDA040776
Marketing category ANDA
Marketing start 2010-08-01
Marketing end 0000-00-00
Substance DEXTROAMPHETAMINE SULFATE
Active strength 5 mg/5mL
Pharmacologic classes Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule CII
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 38 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 13551-701-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 13551-701-05 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 13551-701-05 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 13551-701-05 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 13551-701-05 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 13551-701-05 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 13551-701-05 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 13551-701-05 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 13551-701-05 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 13551-701-05 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 13551-701-05 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 13551-701-05 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 13551-701-05 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 13551-701-05 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 13551-701-05 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 13551-701-05 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 13551-701-05 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 13551-701-05 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 13551-701-05 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040776-001 DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040776-001 AA
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 · 43 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 2026-09-14 22:38:34 2026-08 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# 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 · 2 matching rows.