FDA.reportPublic FDA data

Ibuprofen and Pseudoephedrine Hydrochloride

Product NDC
68016-423
11-digit product format
680160423
Labeler code
68016
Product ID
68016-423_d6590d81-05ee-4a64-9a20-712ac2d8a6f9
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen and Pseudoephedrine Hydrochloride
Dosage form
TABLET, SUGAR COATED
Route
ORAL
Labeler
Chain Drug Consortium, LLC.
Application
ANDA074567
Marketing category
ANDA
Marketing start
2001-10-13
Marketing end
0000-00-00
Substance
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
200 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-423-212020-01-31C16284748780-19d75b9d0-d5bb-f424-e053-dadaa90a57ceIbuprofen and Pseudoephedrine Hydrochloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-423-21Ibuprofen and Pseudoephedrine Hydrochloride20 in 1 BLISTER PACKTABLET, SUGAR COATED204

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG CONSORTIUM, LLC.]3
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG CONSORTIUM, LLC.]3
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG CONSORTIUM, LLC.]3
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG CONSORTIUM, LLC.]3
ACACIAINACTIVE INGREDIENT5C5403N26OIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG CONSORTIUM, LLC.]3
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG CONSORTIUM, LLC.]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG CONSORTIUM, LLC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG CONSORTIUM, LLC.]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG CONSORTIUM, LLC.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG CONSORTIUM, LLC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG CONSORTIUM, LLC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG CONSORTIUM, LLC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG CONSORTIUM, LLC.]3
GELATININACTIVE INGREDIENT2G86QN327LIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG CONSORTIUM, LLC.]3
GUAR GUMINACTIVE INGREDIENTE89I1637KEIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG CONSORTIUM, LLC.]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG CONSORTIUM, LLC.]3
KAOLININACTIVE INGREDIENT24H4NWX5COIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG CONSORTIUM, LLC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG CONSORTIUM, LLC.]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG CONSORTIUM, LLC.]3
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG CONSORTIUM, LLC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG CONSORTIUM, LLC.]3
SHELLACINACTIVE INGREDIENT46N107B71OIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG CONSORTIUM, LLC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG CONSORTIUM, LLC.]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG CONSORTIUM, LLC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG CONSORTIUM, LLC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG CONSORTIUM, LLC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG CONSORTIUM, LLC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG CONSORTIUM, LLC.]3
TRISTEARININACTIVE INGREDIENTP6OCJ2551RIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG CONSORTIUM, LLC.]3
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG CONSORTIUM, LLC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-423IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG CONSORTIUM, LLC.]4Legacy NDC, 1 package rows20180518_f604ba33-dea5-44e1-a27c-a7e6766f0fa5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1299021ibuprofen 200 MG / pseudoephedrine HCl 30 MG Oral TabletPSNf604ba33-dea5-44e1-a27c-a7e6766f0fa54
1299021ibuprofen 200 MG / pseudoephedrine hydrochloride 30 MG Oral TabletSCDf604ba33-dea5-44e1-a27c-a7e6766f0fa54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68016-423-216801604232120 in 1 BLISTER PACKHistorical