Home NDC 80159-112 picnic antihistamine
Product NDC 80159-112
11-digit product format 801590112
Labeler code 80159
Product ID 80159-112_6f8209d9-f5fa-4732-a007-f2290351a7a0
Type HUMAN OTC DRUG
Nonproprietary name fexofenadine hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler 30M One, Inc.
Application ANDA212971
Marketing category ANDA
Marketing start 2022-04-24
Marketing end 0000-00-00
Substance FEXOFENADINE HYDROCHLORIDE
Active strength 180 mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 27 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212971-001 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 A212971-002 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24
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 2 · 74 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 2026-02-19 14:30 UTC 2026-02 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 87673890dc5c…
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 2 · 22 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 80159-112-01 80159011201 1 BOTTLE in 1 CARTON (80159-112-01) > 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2022-04-24 0000-00-00 No No Current 80159-112-03 80159011203 1 BOTTLE in 1 CAPSULE (80159-112-03) > 90 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2022-04-25 0000-00-00 No No Current