FDA.reportPublic FDA data

Fexofenadine HCl and Pseudoephedrine HCI

Product NDC
49035-273
Requested package NDC
49035-273-30
11-digit product format
490350273
Labeler code
49035
Product ID
49035-273_89a65237-243f-d6ec-f917-07450a7670b2
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl and Pseudoephedrine HCI
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Wal-mart Stores Inc.
Application
ANDA076667
Marketing category
ANDA
Marketing start
2019-12-31
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
60 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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49035-27349035-273-30DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-18

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
2026-08-01 22:54:322026-06A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-18a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fexofenadine HCl and Pseudoephedrine HCIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCIDr. Reddy's Laboratories Limited728632be-7e5c-2d06-4c95-bc8ecc9be2ec2024-12-19WarningsExact identifier
application applno (ANDA): 076667
application number: ANDA076667
Allergy and CongestionFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCIRite Aid Corporation90e1aa06-b769-e8ac-af88-1d6a256b94872020-05-19WarningsExact identifier
application applno (ANDA): 076667
application number: ANDA076667
Fexofenadine HCl and Pseudoephedrine HCIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCIDr. Reddy's Laboratories Inc.6fd05737-d996-b5b6-dccf-bc179a9d606c2019-09-09WarningsExact identifier
application applno (ANDA): 076667
application number: ANDA076667
Fexofenadine HCl and Pseudoephedrine HCIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCIThe Kroger Co.8cf0b878-ec13-fd44-d56f-f44af7c249ed2018-10-01WarningsExact identifier
application applno (ANDA): 076667
application number: ANDA076667
Fexofenadine HCl and Pseudoephedrine HCIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCIThe Kroger Co.cb9e98a9-74e6-7a3e-9c5e-3bc35c4bbca62017-12-07WarningsExact identifier
application applno (ANDA): 076667
application number: ANDA076667
Fexofenadine HCl and Pseudoephedrine HCIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCIHEB0de7fc37-7f46-4e98-d5ac-d31a3c313a622017-12-07WarningsExact identifier
application applno (ANDA): 076667
application number: ANDA076667
Fexofenadine HCl and Pseudoephedrine HCIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCICVS Pharmacy3e295047-1a46-a0d8-2e3f-ec4086f5aedb2015-08-24WarningsExact identifier
application applno (ANDA): 076667
application number: ANDA076667
Fexofenadine HCl and Pseudoephedrine HCIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCIWalgreens Company37c1ce51-fb5d-7ebf-bbcd-1b2fd41d45b32015-08-04WarningsExact identifier
application applno (ANDA): 076667
application number: ANDA076667

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-273-20EA - Each49035-2731e11a712-53a0-4c4e-a847-993137cfffca12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-273FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [WAL-MART STORES INC.]6Legacy NDC20241031_1cbd3321-94c4-8c49-c520-6767aefe03ea.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-273-30490350273306 BLISTER PACK in 1 CARTON (49035-273-30) > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK6 blister pack2019-12-310000-00-00NoNoCurrent