FDA.reportPublic FDA data

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

Product NDC
0363-0270
11-digit product format
003630270
Labeler code
0363
Product ID
0363-0270_db9e5d0b-a865-49e7-b5c4-1fc6eb205339
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
WALGREEN CO.
Application
ANDA215232
Marketing category
ANDA
Marketing start
2026-08-27
Substance
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
180; 240 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215232-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE180MG;240MGTABLET, EXTENDED RELEASE / ORAL2025-04-17

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A215232-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE180MG;240MGTABLET, EXTENDED RELEASE / ORAL2025-04-1784e616aacf4f…
2026-08-18 06:07:402026-07A215232-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE180MG;240MGTABLET, EXTENDED RELEASE / ORAL2025-04-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215232-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE180MG;240MGTABLET, EXTENDED RELEASE / ORAL2025-04-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215232-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE180MG;240MGTABLET, EXTENDED RELEASE / ORAL2025-04-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A215232-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE180MG;240MGTABLET, EXTENDED RELEASE / ORAL2025-04-176a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215232-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE180MG;240MGTABLET, EXTENDED RELEASE / ORAL2025-04-17a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE180 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE240 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2S068B75ZUInternal UNII lookup
6V9V2RYJ8NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
997415Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4daddd32-615f-aedf-e063-6394a90a5b09Available on FDA.report

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEWALGREEN CO.4daddd32-615f-aedf-e063-6394a90a5b092026-09-01WarningsExact identifier
application applno (ANDA): 215232
application number: ANDA215232
ndc (product): 0363-0270
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEAurohealth LLCbced0a2e-047e-456e-bbd2-495e83bf07ee2025-04-18WarningsExact identifier
application applno (ANDA): 215232
application number: ANDA215232

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-0270-10003630270102 BLISTER PACK in 1 CARTON (0363-0270-10) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2026-08-27NoNoCurrent