FDA.reportPublic FDA data

Ibuprofen and Pseudoephedrine Hydrochloride

Product NDC
63868-453
11-digit product format
638680453
Labeler code
63868
Product ID
63868-453_9b971e5f-98b5-4030-96d0-2b8aa5c03609
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen and Pseudoephedrine Hydrochloride
Dosage form
TABLET, SUGAR COATED
Route
ORAL
Labeler
Chain Drug Marketing Association Inc.
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
63868-453-202020-01-31C16284748780-19d75b9d1-16c8-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-453-20Ibuprofen and Pseudoephedrine Hydrochloride20 in 1 BLISTER PACKTABLET, SUGAR COATED202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-453-20EA - Each63868-45318807e03-5d45-416e-90bf-79d792592f8012013-02-13

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-453IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]2Legacy NDC, 1 package rows20121114_093e6388-54f2-4d04-ba55-8f7c9c182a0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1299021ibuprofen 200 MG / pseudoephedrine HCl 30 MG Oral TabletPSN093e6388-54f2-4d04-ba55-8f7c9c182a0e2
1299021ibuprofen 200 MG / pseudoephedrine hydrochloride 30 MG Oral TabletSCD093e6388-54f2-4d04-ba55-8f7c9c182a0e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63868-453-206386804532020 in 1 BLISTER PACKHistorical