FDA.reportPublic FDA data

Ibuprofen and Pseudoephedrine Hydrochloride

Product NDC
0363-0423
11-digit product format
003630423
Labeler code
0363
Product ID
0363-0423_28d9145e-3aa3-4a6e-97d4-591a5ff16be9
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen and Pseudoephedrine Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
WALGREEN COMPANY
Application
ANDA074567
Marketing category
ANDA
Marketing start
2017-08-01
Substance
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
200; 30 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], 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
Ibuprofen and Pseudoephedrine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM, 6V9V2RYJ8N
Rxcui1299021

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
0363-0423-212020-06-18C16284748780-19d75b9d0-6e9e-f424-e053-dadaa90a57ceIBUPROFEN & PSEUDOEPHEDRINE HCl TABLETS, USP
0363-0423-412020-06-18C16284748780-19d75b9d0-6e9e-f424-e053-dadaa90a57ceIBUPROFEN & PSEUDOEPHEDRINE HCl TABLETS, USP
0363-0423-212020-01-31C16284748780-19d75b9d0-6e9e-f424-e053-dadaa90a57ceIBUPROFEN & PSEUDOEPHEDRINE HCl TABLETS, USP
0363-0423-412020-01-31C16284748780-19d75b9d0-6e9e-f424-e053-dadaa90a57ceIBUPROFEN & PSEUDOEPHEDRINE HCl TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0423-21Ibuprofen and Pseudoephedrine Hydrochloride20 in 1 BLISTER PACKTABLET, COATED204
0363-0423-41Ibuprofen and Pseudoephedrine Hydrochloride40 in 1 BLISTER PACKTABLET, COATED404

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0423-21EA - Each0363-0423f03f224d-3279-402b-b997-042ad873925112014-10-03
0363-0423-41EA - Each0363-0423ddc792d5-003e-4cf8-8207-3cc284f8f7ef12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY]1
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY]1
ACACIAINACTIVE INGREDIENT5C5403N26OIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY]1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY]1
GELATININACTIVE INGREDIENT2G86QN327LIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY]1
GUAR GUMINACTIVE INGREDIENTE89I1637KEIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY]1
KAOLININACTIVE INGREDIENT24H4NWX5COIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY]1
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY]1
SHELLACINACTIVE INGREDIENT46N107B71OIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY]1
SUCROSEINACTIVE INGREDIENTC151H8M554IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY]1
TALCINACTIVE INGREDIENT7SEV7J4R1UIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY]1
TRISTEARININACTIVE INGREDIENTP6OCJ2551RIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0423IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY]4Current NDC, Legacy NDC, 2 package rows20221013_c3b302c6-a2d2-491c-8f56-ecc25dd1f6c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1299021ibuprofen 200 MG / pseudoephedrine HCl 30 MG Oral TabletPSNc3b302c6-a2d2-491c-8f56-ecc25dd1f6c04
1299021ibuprofen 200 MG / pseudoephedrine hydrochloride 30 MG Oral TabletSCDc3b302c6-a2d2-491c-8f56-ecc25dd1f6c04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-0423-210036304232120 TABLET, COATED in 1 BLISTER PACK (0363-0423-21) 2017-08-010000-00-00NoNoCurrent
0363-0423-410036304234140 TABLET, COATED in 1 BLISTER PACK (0363-0423-41) 2017-08-010000-00-00NoNoCurrent