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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040776-001DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A040776-001AA

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-293f01610625f2…
2019-09-15 20:21 UTC2019-09A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040776-001DEXTROAMPHETAMINE SULFATE5MG/5MLSOLUTION / ORALAARS2008-01-29cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040776-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040776-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040776-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040776-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040776-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040776-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040776-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040776-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040776-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040776-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040776-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040776-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040776-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040776-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040776-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040776-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040776-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040776-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040776-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040776-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040776-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040776-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040776-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040776-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040776-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040776-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040776-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040776-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040776-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040776-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040776-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040776-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040776-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040776-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040776-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040776-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040776-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040776-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040776-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040776-001AA1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
PROCENTRA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROAMPHETAMINE SULFATE5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JJ768O327NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
884522Internal RxNorm lookup
884526Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1548cce2-fb6b-4f17-8a3b-868933f6c9d6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0f66b30d-6b15-4b2d-91a5-1531b9bb6d21Product name720250625
917bdf48-c3f5-4a58-ac8e-d2d94a9c1e2bProduct name220250616
b4c312b9-fad5-247e-cef9-87a74220463dProduct name520230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
8170729e-5ba4-46f9-830f-5f0fae5942ceProduct name120230103
2a7aa275-a4ca-44eb-971f-47427a374085Product name920220615
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aa1b3c66-c4f6-78f2-abd3-31cc9d555e27Product name520190913
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
b4c312b9-fad5-247e-cef9-87a74220463dProduct name420171211
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
ffdf7f68-0f44-4dd6-a026-336dcb345fc4Product name120151109
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21724-701-05PROCENTRA473 mL in 1 BOTTLE, PLASTICSOLUTION47317

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21724-701-05ML - Milliliter21724-70142540cd2-2742-4750-a47a-554250166a6912014-08-01

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21724-701PROCENTRA (DEXTROAMPHETAMINE SULFATE) SOLUTION [INDEPENDENCE PHARMACEUTICALS, LLC]16Current NDC, Legacy NDC, 1 package rows20250121_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROCENTRADEXTROAMPHETAMINE SULFATEINDEPENDENCE PHARMACEUTICALS, LLC1548cce2-fb6b-4f17-8a3b-868933f6c9d62025-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040776
application number: ANDA040776
ndc (product): 21724-701
Dextroamphetamine SulfateDEXTROAMPHETAMINE SULFATEPrasco Laboratories94674695-aa8a-3150-e053-2995a90a445f2025-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040776
application number: ANDA040776

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884522dextroamphetamine sulfate 5 MG in 5 mL Oral SolutionPSN1548cce2-fb6b-4f17-8a3b-868933f6c9d617
884526ProCentra 5 MG in 5 mL Oral SolutionPSN1548cce2-fb6b-4f17-8a3b-868933f6c9d617
884526dextroamphetamine sulfate 1 MG/ML Oral Solution [ProCentra]SBD1548cce2-fb6b-4f17-8a3b-868933f6c9d617
884522dextroamphetamine sulfate 1 MG/ML Oral SolutionSCD1548cce2-fb6b-4f17-8a3b-868933f6c9d617
884522dextroamphetamine sulfate 5 MG per 5 ML Oral SolutionSY1548cce2-fb6b-4f17-8a3b-868933f6c9d617
884526ProCentra 1 MG/ML Oral SolutionSY1548cce2-fb6b-4f17-8a3b-868933f6c9d617
884526ProCentra 5 MG per 5 ML Oral SolutionSY1548cce2-fb6b-4f17-8a3b-868933f6c9d617

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21724-701-0521724070105473 mL in 1 BOTTLE, PLASTIC (21724-701-05) 473 ml2014-05-150000-00-00NoNoCurrent