FDA.reportPublic FDA data

Brompheniramine maleate, pseudoephedrine hydrochloride,

Product NDC
71930-026
11-digit product format
719300026
Labeler code
71930
Product ID
71930-026_de0181e9-03ff-4ec7-8b92-ec877f2f82c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Brompheniramine maleate, pseudoephedrine hydrochloride,
Dosage form
SYRUP
Route
ORAL
Labeler
Eywa Pharma Inc
Application
ANDA211170
Marketing category
ANDA
Marketing start
2020-06-26
Substance
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
2; 10; 30 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], 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
Brompheniramine maleate, pseudoephedrine hydrochloride,
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BROMPHENIRAMINE MALEATE2 mg/5mL
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL
PSEUDOEPHEDRINE HYDROCHLORIDE30 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIXA7C9ZN03, 9D2RTI9KYH, 6V9V2RYJ8N
Rxcui1357010

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
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
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71930-026-18Brompheniramine maleate, pseudoephedrine hydrochloride,118 mL in 1 BOTTLESYRUP1182
71930-026-43Brompheniramine maleate, pseudoephedrine hydrochloride,473 mL in 1 BOTTLESYRUP4732

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71930-026-18ML - Milliliter71930-026e069d102-3af1-450c-b3bb-ac57e21a432712020-07-13
71930-026-43ML - Milliliter71930-0269fb7136b-832c-4206-ae4d-27855a67176f12020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71930-026BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, SYRUP [EYWA PHARMA INC]1Current NDC, Legacy NDC, 2 package rows20200626_8a4b2d13-d1c9-416f-95fd-f7d7b7970bb5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1357010brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG in 5 mL Oral SolutionPSN8a4b2d13-d1c9-416f-95fd-f7d7b7970bb52
1357010brompheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral SolutionSCD8a4b2d13-d1c9-416f-95fd-f7d7b7970bb52
1357010brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG per 5 ML Oral SolutionSY8a4b2d13-d1c9-416f-95fd-f7d7b7970bb52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71930-026-1871930002618118 mL in 1 BOTTLE (71930-026-18) 118 ml2020-06-260000-00-00NoNoCurrent
71930-026-4371930002643473 mL in 1 BOTTLE (71930-026-43) 473 ml2020-06-260000-00-00NoNoCurrent