FDA.reportPublic FDA data

SudoGest 12 Hour

Product NDC
0904-6754
11-digit product format
009046754
Labeler code
0904
Product ID
0904-6754_a689a700-468b-45ac-8849-371a604587f4
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine HCl
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA075153
Marketing category
ANDA
Marketing start
2019-02-12
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
120 mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6V9V2RYJ8N
Rxcui1049154, 1049156

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
0904-6754-15SudoGest 12 Hour1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE14
0904-6754-15SudoGest 12 Hour10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6754-15EA - Each0904-675426d530d6-f69b-4c66-bcd3-85208b15e58712019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6754SUDOGEST 12 HOUR (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]3Current NDC, Legacy NDC, 2 package rows20221111_e829aab0-3ef0-4149-8197-96c5ce0b31d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049154pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSNe829aab0-3ef0-4149-8197-96c5ce0b31d24
1049156SudoGest 120 MG 12HR Extended Release Oral TabletPSNe829aab0-3ef0-4149-8197-96c5ce0b31d24
104915612 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet [Sudogest]SBDe829aab0-3ef0-4149-8197-96c5ce0b31d24
104915412 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCDe829aab0-3ef0-4149-8197-96c5ce0b31d24
104915612 HR Sudogest 120 MG Extended Release Oral TabletSYe829aab0-3ef0-4149-8197-96c5ce0b31d24
1049154pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSYe829aab0-3ef0-4149-8197-96c5ce0b31d24
1049156Sudogest 120 MG 12 HR Extended Release Oral TabletSYe829aab0-3ef0-4149-8197-96c5ce0b31d24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6754-150090467541510 BLISTER PACK in 1 CARTON (0904-6754-15) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2019-02-120000-00-00NoNoCurrent