Aprodine

Product NDC
0904-0250
11-digit product format
009040250
Labeler code
0904
Product ID
0904-0250_6b9ac09b-25c3-49bd-8561-a162d044d89c
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine HCl and Triprolidine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1993-01-09
Marketing end
0000-00-00
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
Active strength
60 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0904-0250DDiscontinued by firm2026-10-05
excluded packagepackage0904-02500904-0250-24DDiscontinued by firm2026-10-05
excluded packagepackage0904-02500904-0250-59DDiscontinued by firm2026-10-05

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 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0904-0250-59d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0904-0250-24d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0904-0250-59f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0904-0250-24f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0904-0250-592ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0904-0250-242ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0904-0250-59a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0904-0250-24a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0904-0250-59cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0904-0250-24cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0904-0250-59cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0904-0250-24cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0904-0250-59302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0904-0250-24302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0904-0250-59ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0904-0250-24ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0904-0250-590efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0904-0250-240efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0904-0250-59ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0904-0250-24ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0904-0250-59367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0904-0250-24367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0904-0250-59557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0904-0250-24557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-0250-24EA - Each0904-0250d0772455-977b-47b4-9366-6cc86a80868112012-07-24
0904-0250-59EA - Each0904-0250ceeebd36-eae4-44ff-af24-2f53364e174912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NAPRODINE (PSEUDOEPHEDRINE HCL AND TRIPOLIDINE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]4
TRIPROLIDINE HYDROCHLORIDEACTIVE INGREDIENTYAN7R5L890APRODINE (PSEUDOEPHEDRINE HCL AND TRIPOLIDINE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]4
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FAPRODINE (PSEUDOEPHEDRINE HCL AND TRIPOLIDINE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]4
TRIPROLIDINEACTIVE MOIETY2L8T9S52QMAPRODINE (PSEUDOEPHEDRINE HCL AND TRIPOLIDINE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAPRODINE (PSEUDOEPHEDRINE HCL AND TRIPOLIDINE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAPRODINE (PSEUDOEPHEDRINE HCL AND TRIPOLIDINE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]4
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GAPRODINE (PSEUDOEPHEDRINE HCL AND TRIPOLIDINE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30APRODINE (PSEUDOEPHEDRINE HCL AND TRIPOLIDINE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAPRODINE (PSEUDOEPHEDRINE HCL AND TRIPOLIDINE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APAPRODINE (PSEUDOEPHEDRINE HCL AND TRIPOLIDINE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAPRODINE (PSEUDOEPHEDRINE HCL AND TRIPOLIDINE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]4
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NAPRODINE (PSEUDOEPHEDRINE HCL AND TRIPOLIDINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TRIPROLIDINE HYDROCHLORIDEACTIVE INGREDIENTYAN7R5L890APRODINE (PSEUDOEPHEDRINE HCL AND TRIPOLIDINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FAPRODINE (PSEUDOEPHEDRINE HCL AND TRIPOLIDINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TRIPROLIDINEACTIVE MOIETY2L8T9S52QMAPRODINE (PSEUDOEPHEDRINE HCL AND TRIPOLIDINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAPRODINE (PSEUDOEPHEDRINE HCL AND TRIPOLIDINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAPRODINE (PSEUDOEPHEDRINE HCL AND TRIPOLIDINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GAPRODINE (PSEUDOEPHEDRINE HCL AND TRIPOLIDINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30APRODINE (PSEUDOEPHEDRINE HCL AND TRIPOLIDINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AAPRODINE (PSEUDOEPHEDRINE HCL AND TRIPOLIDINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APAPRODINE (PSEUDOEPHEDRINE HCL AND TRIPOLIDINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAPRODINE (PSEUDOEPHEDRINE HCL AND TRIPOLIDINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099446pseudoephedrine HCl 60 MG / triprolidine HCl 2.5 MG Oral TabletPSN2b0171a1-3f08-4360-aba3-b13344a5262320
1099446pseudoephedrine hydrochloride 60 MG / triprolidine hydrochloride 2.5 MG Oral TabletSCD2b0171a1-3f08-4360-aba3-b13344a5262320
1099446pseudoephedrine HCl 60 MG / triprolidine HCl 2.5 MG Oral TabletPSNe5e84aa0-a99d-47ae-983b-fc03f0f2c7541
1099446pseudoephedrine hydrochloride 60 MG / triprolidine hydrochloride 2.5 MG Oral TabletSCDe5e84aa0-a99d-47ae-983b-fc03f0f2c7541

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-0250-24009040250241 BLISTER PACK in 1 CARTON (0904-0250-24) > 24 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack1993-01-090000-00-00NoNoCurrent
0904-0250-59009040250591 BOTTLE, PLASTIC in 1 CARTON (0904-0250-59) > 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1993-01-090000-00-00NoNoCurrent