Loratadine

Product NDC
71335-0751
11-digit product format
713350751
Labeler code
71335
Product ID
71335-0751_cb0713c2-3e88-48f7-b78e-7be9c84eeffd
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075209
Marketing category
ANDA
Marketing start
2003-01-21
Marketing end
0000-00-00
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 10 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71335-0751DDiscontinued by firm2026-10-05
excluded packagepackage71335-075171335-0751-1DDiscontinued by firm2026-10-05
excluded packagepackage71335-075171335-0751-2DDiscontinued by firm2026-10-05
excluded packagepackage71335-075171335-0751-3DDiscontinued by firm2026-10-05
excluded packagepackage71335-075171335-0751-4DDiscontinued by firm2026-10-05
excluded packagepackage71335-075171335-0751-5DDiscontinued by firm2026-10-05
excluded packagepackage71335-075171335-0751-6DDiscontinued by firm2026-10-05
excluded packagepackage71335-075171335-0751-7DDiscontinued by firm2026-10-05
excluded packagepackage71335-075171335-0751-8DDiscontinued by firm2026-10-05
excluded packagepackage71335-075171335-0751-9DDiscontinued by firm2026-10-05

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 2 · 120 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0751-7d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0751-8d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0751-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0751-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0751-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0751-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0751-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0751-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0751-4d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0751-7f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0751-8f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0751-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0751-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0751-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0751-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0751-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0751-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0751-4f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0751-72ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0751-82ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0751-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0751-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0751-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0751-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0751-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0751-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0751-42ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0751-7a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0751-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0751-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0751-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0751-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0751-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0751-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0751-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0751-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0751-7cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0751-8cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0751-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0751-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0751-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0751-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0751-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0751-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0751-4cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0751-7cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0751-8cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0751-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0751-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0751-9cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0751-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0751-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0751-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0751-4cdf11ea48f46…ba0047e9e063…

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
A075209-001LORATADINELORATADINE10MGTABLET / ORAL2003-01-21

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075209-001LORATADINE10MGTABLET / ORAL2003-01-2184e616aacf4f…
2026-08-18 06:07:402026-07A075209-001LORATADINE10MGTABLET / ORAL2003-01-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075209-001LORATADINE10MGTABLET / ORAL2003-01-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075209-001LORATADINE10MGTABLET / ORAL2003-01-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075209-001LORATADINE10MGTABLET / ORAL2003-01-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075209-001LORATADINE10MGTABLET / ORAL2003-01-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075209-001LORATADINE10MGTABLET / ORAL2003-01-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075209-001LORATADINE10MGTABLET / ORAL2003-01-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075209-001LORATADINE10MGTABLET / ORAL2003-01-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075209-001LORATADINE10MGTABLET / ORAL2003-01-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075209-001LORATADINE10MGTABLET / ORAL2003-01-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075209-001LORATADINE10MGTABLET / ORAL2003-01-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075209-001LORATADINE10MGTABLET / ORAL2003-01-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075209-001LORATADINE10MGTABLET / ORAL2003-01-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075209-001LORATADINE10MGTABLET / ORAL2003-01-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075209-001LORATADINE10MGTABLET / ORAL2003-01-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075209-001LORATADINE10MGTABLET / ORAL2003-01-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075209-001LORATADINE10MGTABLET / ORAL2003-01-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075209-001LORATADINE10MGTABLET / ORAL2003-01-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075209-001LORATADINE10MGTABLET / ORAL2003-01-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075209-001LORATADINE10MGTABLET / ORAL2003-01-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075209-001LORATADINE10MGTABLET / ORAL2003-01-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075209-001LORATADINE10MGTABLET / ORAL2003-01-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A075209-001LORATADINE10MGTABLET / ORAL2003-01-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075209-001LORATADINE10MGTABLET / ORAL2003-01-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075209-001LORATADINE10MGTABLET / ORAL2003-01-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075209-001LORATADINE10MGTABLET / ORAL2003-01-213f01610625f2…
2019-09-15 20:21 UTC2019-09A075209-001LORATADINE10MGTABLET / ORAL2003-01-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A075209-001LORATADINE10MGTABLET / ORAL2003-01-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075209-001LORATADINE10MGTABLET / ORAL2003-01-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075209-001LORATADINE10MGTABLET / ORAL2003-01-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075209-001LORATADINE10MGTABLET / ORAL2003-01-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075209-001LORATADINE10MGTABLET / ORAL2003-01-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075209-001LORATADINE10MGTABLET / ORAL2003-01-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075209-001LORATADINE10MGTABLET / ORAL2003-01-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075209-001LORATADINE10MGTABLET / ORAL2003-01-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A075209-001LORATADINE10MGTABLET / ORAL2003-01-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A075209-001LORATADINE10MGTABLET / ORAL2003-01-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075209-001LORATADINE10MGTABLET / ORAL2003-01-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075209-001LORATADINE10MGTABLET / ORAL2003-01-21f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0751-2EA - Each71335-0751a4779790-eb8e-4483-a807-e402bd134ed712018-08-13

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 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
All Day Allergy ReliefLORATADINESafeway, Inc.9e581ae1-d1e6-4038-86e8-fd0c5ab9878a2026-08-19WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
All Day Allergy ReliefLORATADINEWALMART INC. (see also Equate)db815af2-4193-4fd9-a028-4a9d54325ca82026-06-18WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
All Day Allergy ReliefLORATADINEWALMART INC. (see also Equate)80958503-400c-422a-a641-e1a3d5a9a6a82026-04-17WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
LoratadineLORATADINENuCare Pharmaceuticals,Inc.c0e3057d-2dd2-de2b-e053-2995a90a1a1d2026-03-05WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
ClaritinLORATADINESelect Consumer Group3c9ad1f8-e8ef-bcd0-e063-6394a90ac20e2025-12-28WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
ClaritinLORATADINEBayer HealthCare LLC.acf2d393-53d7-062f-e053-2995a90a0d602025-12-04WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
ClaritinLORATADINEBayer HealthCare LLC.dc65f7ec-bb83-7b29-e053-2995a90a99de2025-12-04WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
All Day Allergy ReliefLORATADINEFamily Dollar (FAMILY WELLNESS)6b8d786e-2ee3-487f-bf7b-7dc738ea2fc92025-10-29WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
Allergy reliefLORATADINEPreferred Pharmaceuticals Inc.836f566c-0296-408a-ad2a-6a77e18552182025-08-29WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
Wal-itinLORATADINEWalgreens6afa8056-1b7a-48a4-960c-92927169977e2025-08-28WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
Allergy reliefLORATADINEGeri-Care Pharmaceutical Corpb66f171a-7b95-b27a-e053-2a95a90a60092025-07-28WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
Allergy ReliefLORATADINEWinCo Foods, LLC706a59fa-3d15-4e6e-a38e-ad3f2ef466002025-04-08WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
CounterAct AllergyLORATADINEMelaleuca, Inc.6b5d43ad-a709-4e0b-b91c-36ea0afe72212025-03-17WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
Allergy reliefLORATADINEBryant Ranch Prepacke87aa69c-9ec6-482d-8e28-32542f6b91662025-02-04WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
Allergy reliefLORATADINEA-S Medication Solutions210fa77a-e33e-48c4-8228-b1cf3ccb7fa42025-01-30WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
ClaritinLORATADINE TABLETLil' Drug Store Products, Inc.f0e77162-c601-1a0f-e053-2a95a90ab7142024-12-31WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
All Day Allergy ReliefLORATADINEQUALITY CHOICE (Chain Drug Marketing Association)a282d209-1015-4570-b9df-7cc0a3753e372024-06-17WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
Allergy ReliefLORATADINEQUALITY CHOICE (Chain Drug Marketing Association)c5acd9d7-2f26-41c5-b369-2122251583ec2024-05-17WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
All Day Allergy ReliefLORATADINEQUALITY CHOICE (Chain Drug Marketing Association)d47a5f1b-fb27-4618-a26e-a5eeabcd87f22024-05-16WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
All Day Allergy ReliefLORATADINEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)7eac9202-bd4c-4550-a257-2b8195a0dbcd2023-11-29WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0751-17133507510120 TABLET in 1 BOTTLE (71335-0751-1) 20 tablet2003-01-210000-00-00NoNoCurrent
71335-0751-27133507510230 TABLET in 1 BOTTLE (71335-0751-2) 30 tablet2003-01-210000-00-00NoNoCurrent
71335-0751-37133507510360 TABLET in 1 BOTTLE (71335-0751-3) 60 tablet2003-01-210000-00-00NoNoCurrent
71335-0751-47133507510414 TABLET in 1 BOTTLE (71335-0751-4) 14 tablet2003-01-210000-00-00NoNoCurrent
71335-0751-57133507510510 TABLET in 1 BOTTLE (71335-0751-5) 10 tablet2003-01-210000-00-00NoNoCurrent
71335-0751-67133507510690 TABLET in 1 BOTTLE (71335-0751-6) 90 tablet2003-01-210000-00-00NoNoCurrent
71335-0751-77133507510728 TABLET in 1 BOTTLE (71335-0751-7) 28 tablet2003-01-210000-00-00NoNoCurrent
71335-0751-87133507510815 TABLET in 1 BOTTLE (71335-0751-8) 15 tablet2003-01-210000-00-00NoNoCurrent
71335-0751-971335075109100 TABLET in 1 BOTTLE (71335-0751-9) 100 tablet2003-01-210000-00-00NoNoCurrent