Home NDC 21724-701 PROCENTRA
Product NDC 21724-701
11-digit product format 217240701
Labeler code 21724
Product ID 21724-701_06b4c32e-1880-40e9-9de2-0927cb8c1500
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dextroamphetamine sulfate
Dosage form SOLUTION
Route ORAL
Labeler INDEPENDENCE PHARMACEUTICALS, LLC
Application ANDA040776
Marketing category ANDA
Marketing start 2014-05-15
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 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 · 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 · 41 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 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…2022-09-29 23:25 UTC 2022-09 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040776-001 DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION / ORAL AA RS 2008-01-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base PROCENTRA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROAMPHETAMINE SULFATE 5 mg/5mL
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 884522 Internal RxNorm lookup 884526 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 21724-701-05 PROCENTRA 473 mL in 1 BOTTLE, PLASTIC SOLUTION 473 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROAMPHETAMINE SULFATE ACTIVE INGREDIENT JJ768O327N PROCENTRA (DEXTROAMPHETAMINE SULFATE) SOLUTION [INDEPENDENCE PHARMACEUTICALS, LLC] 3 DEXTROAMPHETAMINE ACTIVE MOIETY TZ47U051FI PROCENTRA (DEXTROAMPHETAMINE SULFATE) SOLUTION [INDEPENDENCE PHARMACEUTICALS, LLC] 3 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL PROCENTRA (DEXTROAMPHETAMINE SULFATE) SOLUTION [INDEPENDENCE PHARMACEUTICALS, LLC] 3 BENZOIC ACID INACTIVE INGREDIENT 8SKN0B0MIM PROCENTRA (DEXTROAMPHETAMINE SULFATE) SOLUTION [INDEPENDENCE PHARMACEUTICALS, LLC] 3 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY PROCENTRA (DEXTROAMPHETAMINE SULFATE) SOLUTION [INDEPENDENCE PHARMACEUTICALS, LLC] 3 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR PROCENTRA (DEXTROAMPHETAMINE SULFATE) SOLUTION [INDEPENDENCE PHARMACEUTICALS, LLC] 3 SORBITOL INACTIVE INGREDIENT 506T60A25R PROCENTRA (DEXTROAMPHETAMINE SULFATE) SOLUTION [INDEPENDENCE PHARMACEUTICALS, LLC] 3 WATER INACTIVE INGREDIENT 059QF0KO0R PROCENTRA (DEXTROAMPHETAMINE SULFATE) SOLUTION [INDEPENDENCE PHARMACEUTICALS, LLC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21724-701 PROCENTRA (DEXTROAMPHETAMINE SULFATE) SOLUTION [INDEPENDENCE PHARMACEUTICALS, LLC] 16 Current NDC, Legacy NDC, 1 package rows 20250121_1548cce2-fb6b-4f17-8a3b-868933f6c9d6.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 · 2 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 21724-701-05 21724070105 473 mL in 1 BOTTLE, PLASTIC (21724-701-05) 473 ml 2014-05-15 0000-00-00 No No Current