SudoGest

Product NDC
0904-5351
11-digit product format
009045351
Labeler code
0904
Product ID
0904-5351_1b9122c9-f8eb-494a-b64b-cc16ca154e29
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine maleate, pseudoephedrine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1992-12-16
Substance
CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
4; 60 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPHENIRAMINE MALEATE4 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV1Q0O9OJ9Z, 6V9V2RYJ8N
Rxcui998254

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
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
0904-5351-24SudoGest24 in 1 BLISTER PACKTABLET2422
0904-5351-24SudoGest1 in 1 CARTONTABLET122
0904-5351-96SudoGest2 in 1 CARTONTABLET222
0904-5351-96SudoGest24 in 1 BLISTER PACKTABLET2422

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5351-24EA - Each0904-53510f9a6680-4520-4451-8edd-397fa5e3476b12013-02-13
0904-5351-96EA - Each0904-535142cabb83-be5b-4ab6-8e48-2ec71619f10312013-07-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-5351SUDOGEST (CHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [MAJOR PHARMACEUTICALS]20Current NDC, Legacy NDC, 4 package rows20250217_7cd8f7f3-c262-4f7c-bcaf-068be2c952f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998254pseudoephedrine HCl 60 MG / chlorpheniramine maleate 4 MG Oral TabletPSN7cd8f7f3-c262-4f7c-bcaf-068be2c952f922
998254chlorpheniramine maleate 4 MG / pseudoephedrine hydrochloride 60 MG Oral TabletSCD7cd8f7f3-c262-4f7c-bcaf-068be2c952f922

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-5351-24009045351241 BLISTER PACK in 1 CARTON (0904-5351-24) / 24 TABLET in 1 BLISTER PACK1 blister pack1992-12-160000-00-00NoNoCurrent
0904-5351-96009045351962 BLISTER PACK in 1 CARTON (0904-5351-96) > 24 TABLET in 1 BLISTER PACK2 blister pack1992-12-162023-01-31NoNoCurrent