Home NDC 62011-0233-1 health mart fexofenadine hydrochloride
Product NDC 62011-0233
Requested package NDC 62011-0233-1
11-digit product format 620110233
Labeler code 62011
Product ID 62011-0233_fab79e6e-1ae0-44cc-8924-4ecc90c65bbd
Type HUMAN OTC DRUG
Nonproprietary name fexofenadine hcl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Strategic Sourcing Services LLC
Application ANDA076447
Marketing category ANDA
Marketing start 2014-04-01
Marketing end 0000-00-00
Substance FEXOFENADINE HYDROCHLORIDE
Active strength 180 mg/1
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 8 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076447-001 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2005-09-01 A076447-002 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2005-09-01 A076447-003 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2005-09-01 A076447-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2011-04-13 A076447-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2011-04-13 A076447-006 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2011-04-13 A076447-007 FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2011-04-13 A076447-008 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2011-04-13
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.
Product history page 1 of 9 · 344 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A076447-001 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2005-09-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076447-002 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2005-09-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076447-003 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2005-09-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076447-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-04-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076447-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-04-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076447-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-04-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076447-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-04-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076447-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-04-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076447-001 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2005-09-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076447-002 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2005-09-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076447-003 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2005-09-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076447-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-04-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076447-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-04-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076447-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-04-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076447-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-04-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076447-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-04-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076447-001 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL AB 2005-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076447-002 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL AB 2005-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076447-003 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL AB 2005-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076447-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-04-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076447-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-04-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076447-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-04-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076447-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-04-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076447-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-04-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076447-001 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL AB 2005-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076447-002 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL AB 2005-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076447-003 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL AB 2005-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076447-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-04-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076447-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-04-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076447-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-04-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076447-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-04-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076447-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-04-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076447-001 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL AB 2005-09-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076447-002 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL AB 2005-09-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076447-003 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL AB 2005-09-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076447-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-04-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076447-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-04-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076447-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-04-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076447-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-04-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076447-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-04-13 6a471c1ec25d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 120 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FEXOFENADINE HYDROCHLORIDE ACTIVE INGREDIENT 2S068B75ZU HEALTH MART FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [MCKESSON] 1 FEXOFENADINE ACTIVE MOIETY E6582LOH6V HEALTH MART FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [MCKESSON] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HEALTH MART FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [MCKESSON] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 HEALTH MART FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [MCKESSON] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 HEALTH MART FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [MCKESSON] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT HEALTH MART FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [MCKESSON] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 HEALTH MART FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [MCKESSON] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO HEALTH MART FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [MCKESSON] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X HEALTH MART FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [MCKESSON] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HEALTH MART FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [MCKESSON] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A HEALTH MART FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [MCKESSON] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E HEALTH MART FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [MCKESSON] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 HEALTH MART FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [MCKESSON] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP HEALTH MART FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [MCKESSON] 1
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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 62011-0233-1 62011023301 1 BOTTLE in 1 CARTON (62011-0233-1) > 70 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2014-04-01 0000-00-00 No No Current