FDA.reportPublic FDA data

Application 212971

Type
ANDA
Sponsor
L PERRIGO CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDETABLET;ORAL60MGNoNo
002FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDETABLET;ORAL180MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212971-001FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-24
A212971-002FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-24

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-244b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-24bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-24782e0a99824c…
2021-12-28 21:50 UTC2021-12A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-2487673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-2487673890dc5c…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HIVES RELIEFFEXOFENADINE HYDROCHLORIDEWalgreen Companya79edb5d-02d9-4c53-9509-c69fd61156862026-07-22WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
Allergy ReliefFEXOFENADINE HYDROCHLORIDEKroger Company2718d6a2-0678-4703-9a5a-26b27d7539422026-07-20WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
careone allergy reliefFEXOFENADINE HYDROCHLORIDERetail Business Services, LLCce398856-e9a6-401d-8636-bc5771a7e28b2026-04-14WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
ndc (product): 72476-847
allergy reliefFEXOFENADINE HYDROCHLORIDEHyVee Inc54635220-dd44-4baa-b929-9e52deb4c3682026-03-25WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
berkley jensen allergy reliefFEXOFENADINE HYDROCHLORIDEBJWC2c6d9f8c-bc74-4e1a-bd51-50f84ab63a152026-02-06WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
ndc (product): 68391-847
Allergy ReliefFEXOFENADINE HYDROCHLORIDECVS Pharmacy7cac266a-4de8-4af1-8324-b01823a3989a2026-01-07WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
topcare allergy reliefFEXOFENADINE HYDROCHLORIDETopco Associates LLCe7658b5f-2d78-4f25-b1a3-e49198ca8f322025-12-22WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
ndc (product): 36800-691
good sense aller easeFEXOFENADINE HYDROCHLORIDEL. Perrigo Companye533a008-b437-401e-ab50-bda31e6662d32025-10-09WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
ndc (product): 0113-0847
up and up non drowsy allergy reliefFEXOFENADINE HYDROCHLORIDETarget Corporationd251b0a6-bc31-45b6-aaa8-f50f8336d9592025-08-19WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
exchange select aller easeFEXOFENADINE HYDROCHLORIDEArmy & Air Force Exchange Service6a9597a1-f024-4497-bc52-3d54827588222025-04-03WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
ndc (product): 55301-847
Leader 24HR Allergy ReliefFEXOFENADINE HYDROCHLORIDECardinal Health 110, LLC. dba Leadere509800a-e33d-4d22-a6b4-97b7c73b14862025-04-01WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
Allergy ReliefFEXOFENADINE HYDROCHLORIDEWalgreen Company99f03481-d169-4aac-8370-20011ff530ea2024-12-13WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
allergy reliefFEXOFENADINE HYDROCHLORIDEMeijer, Inc.deecbf76-be1d-4b27-85c6-17cfb7e7d1a12024-07-25WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
ndc (product): 79481-0847
basic care allergyFEXOFENADINE HYDROCHLORIDEAmazon.com Services LLCc2f30390-3d32-4489-9df2-caf848ce040b2024-07-17WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
ndc (product): 72288-847
Basic Care AllergyFEXOFENADINE HYDROCHLORIDEAmazon.com Services LLC27202f58-a488-42cc-b63f-be892c5b4de22024-05-10WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
Basic Care AllergyFEXOFENADINE HYDROCHLORIDEAmazon.com Services LLCc29d281f-89dd-4c69-8572-6599400c660f2024-04-22WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
allergy reliefFEXOFENADINE HYDROCHLORIDEWalgreen Companya0738300-7262-4e43-89a6-0d0a60bd14bd2024-02-14WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
kirkland signature aller fexFEXOFENADINE HYDROCHLORIDECostco Wholesale Company651d14d1-c5de-4cb9-9484-b05986e641ac2023-05-02WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
ndc (product): 63981-847
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEProficient Rx LP4a9b4b7f-0441-44d3-86c7-2542ef4b119a2022-12-01WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
ndc (product): 71205-739
dg health aller easeFEXOFENADINE HYDROCHLORIDEDolgencorp Incf9239aa4-b3d0-4817-b639-61ad1383f7072022-06-28WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
ndc (product): 55910-609

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-0847good sense aller easefexofenadine hydrochlorideL. Perrigo CompanyANDACurrent
11673-617up and up allergy relieffexofenadine hydrochlorideTarget CorporationANDACurrent
36800-691topcare allergy relieffexofenadine hydrochlorideTopco Associates LLCANDACurrent
37808-847allergy relieffexofenadine hydrochlorideH E BANDACurrent
45802-847Fexofenadine Hydrochloridefexofenadine hydrochloridePadagis Israel Pharmaceuticals LtdANDACurrent
55301-847exchange select aller easefexofenadine hydrochlorideArmy & Air Force Exchange ServiceANDACurrent
55301-847exchange select aller easefexofenadine hydrochlorideArmy & Air Force Exchange ServiceANDACurrent
55910-609dg health aller easefexofenadine hydrochlorideDolgencorp IncANDACurrent
56062-847allergy relieffexofenadine hydrochloridePublix Super Markets IncANDACurrent
63629-9463Fexofenadine Hydrochloridefexofenadine hydrochlorideBryant Ranch PrepackANDACurrent
63629-9463Fexofenadine Hydrochloridefexofenadine hydrochlorideBryant Ranch PrepackANDACurrent
63981-847kirkland signature aller fexfexofenadine hydrochlorideCostco Wholesale CompanyANDACurrent
68391-847berkley jensen allergy relieffexofenadine hydrochlorideBJWCANDACurrent
71205-739Fexofenadine Hydrochloridefexofenadine hydrochlorideProficient Rx LPANDACurrent
72288-847basic care allergyfexofenadine hydrochlorideAmazon.com Services LLCANDACurrent
72476-847careone allergy relieffexofenadine hydrochlorideRetail Business Services, LLCANDACurrent
79481-0847allergy relieffexofenadine hydrochlorideMeijer, Inc.ANDACurrent
80159-112picnic antihistaminefexofenadine hydrochloride30M One, Inc.ANDACurrent