FDA.reportPublic FDA data

Pseudoephedrine Hydrochloride

Product NDC
58602-884
11-digit product format
586020884
Labeler code
58602
Product ID
58602-884_77e4132e-470e-4fb4-bc2f-df2e59061ba9
Type
HUMAN OTC DRUG
Nonproprietary name
pseudoephedrine hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA218854
Marketing category
ANDA
Marketing start
2025-12-29
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
240 mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
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 42.

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
A218854-001PSEUDOEPHEDRINE HYDROCHLORIDEPSEUDOEPHEDRINE HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALRS2025-12-29

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A218854-001PSEUDOEPHEDRINE HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALRS2025-12-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218854-001PSEUDOEPHEDRINE HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALRS2025-12-29011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218854-001PSEUDOEPHEDRINE HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALRS2025-12-29a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Pseudoephedrine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE240 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6V9V2RYJ8NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049670Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
77e4132e-470e-4fb4-bc2f-df2e59061ba9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-884-27Pseudoephedrine Hydrochloride1 in 1 CARTONTABLET, EXTENDED RELEASE11
58602-884-27Pseudoephedrine Hydrochloride10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE101
58602-884-58Pseudoephedrine Hydrochloride5 in 1 BLISTER PACKTABLET, EXTENDED RELEASE51
58602-884-58Pseudoephedrine Hydrochloride2 in 1 CARTONTABLET, EXTENDED RELEASE21

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
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEWALGREEN CO.1425a847-bf34-1795-e063-6294a90a85b62026-02-03WarningsExact identifier
application applno (ANDA): 218854
application number: ANDA218854
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEAurohealth LLC77e4132e-470e-4fb4-bc2f-df2e59061ba92026-01-06WarningsExact identifier
application applno (ANDA): 218854
application number: ANDA218854
ndc (product): 58602-884

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049670pseudoephedrine HCl 240 MG 24HR Extended Release Oral TabletPSN77e4132e-470e-4fb4-bc2f-df2e59061ba91
104967024 HR pseudoephedrine hydrochloride 240 MG Extended Release Oral TabletSCD77e4132e-470e-4fb4-bc2f-df2e59061ba91
1049670pseudoephedrine hydrochloride 240 MG 24 HR Extended Release Oral TabletSY77e4132e-470e-4fb4-bc2f-df2e59061ba91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58602-884-27586020884271 BLISTER PACK in 1 CARTON (58602-884-27) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2025-12-29NoNoCurrent
58602-884-58586020884582 BLISTER PACK in 1 CARTON (58602-884-58) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2025-12-29NoNoCurrent