FDA.reportPublic FDA data

SudoGest

Product NDC
50090-0155
Requested package NDC
50090-0155-1
11-digit product format
500900155
Labeler code
50090
Product ID
50090-0155_9d203c5a-1336-4a71-b937-48c1a8ba7fe4
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1984-12-07
Marketing end
0000-00-00
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
60 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-015550090-0155-1IInactivated by FDA2026-08-11

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
50090-0155-0SudoGest Nasal Decongestant
50090-0155-1SudoGest Nasal Decongestant
50090-0155-3SudoGest Nasal Decongestant
50090-0155-4SudoGest Nasal Decongestant
50090-0155-5SudoGest Nasal Decongestant

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0155-0SudoGest24 in 1 BOTTLETABLET, FILM COATED2417
50090-0155-1SudoGest30 in 1 BOTTLETABLET, FILM COATED3017
50090-0155-3SudoGest12 in 1 BOTTLETABLET, FILM COATED1217
50090-0155-4SudoGest20 in 1 BOTTLETABLET, FILM COATED2017
50090-0155-5SudoGest15 in 1 BOTTLETABLET, FILM COATED1517

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0155-1EA - Each50090-0155de3e4ae3-fb9b-44ed-a7d1-4f3bfd513a3f12018-08-13
50090-0155-3EA - Each50090-01553fa82e27-e412-4187-82c2-4697cd4c2be512018-08-13
50090-0155-4EA - Each50090-01550d6cc164-c872-4976-bc13-d78fad9b3cad12018-08-13
50090-0155-5EA - Each50090-015521a1955c-e6e6-441e-bb3f-6e30e413941a12018-08-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0155SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]17Legacy NDC, 5 package rows20210415_065ad37b-5200-4b45-a626-4b29452b4ec7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049167pseudoephedrine HCl 60 MG Oral TabletPSN065ad37b-5200-4b45-a626-4b29452b4ec717
1049169SudoGest 60 MG Oral TabletPSN065ad37b-5200-4b45-a626-4b29452b4ec717
1049169pseudoephedrine hydrochloride 60 MG Oral Tablet [Sudogest]SBD065ad37b-5200-4b45-a626-4b29452b4ec717
1049167pseudoephedrine hydrochloride 60 MG Oral TabletSCD065ad37b-5200-4b45-a626-4b29452b4ec717
1049169Sudogest 60 MG Oral TabletSY065ad37b-5200-4b45-a626-4b29452b4ec717

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0155-15009001550130 TABLET, FILM COATED in 1 BOTTLE (50090-0155-1) 2014-11-280000-00-00NoNoCurrent