Loratadine

Product NDC
50090-3620
11-digit product format
500903620
Labeler code
50090
Product ID
50090-3620_f64c925a-d437-46fa-9dc8-158a824f8d38
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075209
Marketing category
ANDA
Marketing start
2016-02-01
Marketing end
0000-00-00
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-3620IInactivated by FDA2026-08-10
excluded packagepackage50090-362050090-3620-0IInactivated by FDA2026-08-10
excluded packagepackage50090-362050090-3620-1IInactivated by FDA2026-08-10
excluded packagepackage50090-362050090-3620-3IInactivated by FDA2026-08-10
excluded packagepackage50090-362050090-3620-4IInactivated by FDA2026-08-10
excluded packagepackage50090-362050090-3620-5IInactivated by FDA2026-08-10
excluded packagepackage50090-362050090-3620-6IInactivated by FDA2026-08-10

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 · 105 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 packagepackage50090-3620-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-3620-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-3620-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-3620-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-3620-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-3620-4d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-3620-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-3620-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-3620-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-3620-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-3620-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-3620-4f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-3620-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-3620-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-3620-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-3620-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-3620-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-3620-42ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-3620-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-3620-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-3620-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-3620-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-3620-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-3620-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-3620-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-3620-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-3620-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-3620-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-3620-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-3620-4cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-3620-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-3620-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-3620-0cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-3620-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-3620-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-3620-4cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-3620-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-3620-5302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-3620-0302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-3620-6302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-3620-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-3620-4302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-3620-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-3620-5ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-3620-0ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-3620-6ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-3620-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-3620-4ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-3620-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-3620-50efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-3620-00efc9e666f02…f202fb6c5f17…

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
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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075209-001LORATADINE10MGTABLET / 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…
2022-09-29 23:25 UTC2022-09A075209-001LORATADINE10MGTABLET / ORAL2003-01-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075209-001LORATADINE10MGTABLET / ORAL2003-01-21cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3620-0Loratadine10 in 1 BOTTLETABLET103
50090-3620-1Loratadine20 in 1 BOTTLE, PLASTICTABLET203
50090-3620-3Loratadine15 in 1 BOTTLE, PLASTICTABLET153
50090-3620-4Loratadine30 in 1 BOTTLE, PLASTICTABLET303
50090-3620-5Loratadine90 in 1 BOTTLE, PLASTICTABLET903
50090-3620-6Loratadine7 in 1 BOTTLE, PLASTICTABLET73

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3620LORATADINE TABLET [A-S MEDICATION SOLUTIONS]3Legacy NDC, 6 package rows20190430_eb7196aa-898b-48d3-a6c7-8b52ff740b30.zip

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 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
All Day Allergy ReliefLORATADINESafeway, Inc.9e581ae1-d1e6-4038-86e8-fd0c5ab9878a2026-01-05WarningsExact 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSNeb7196aa-898b-48d3-a6c7-8b52ff740b303
311372loratadine 10 MG Oral TabletSCDeb7196aa-898b-48d3-a6c7-8b52ff740b303
311372loratadine 10 MG 24 HR Oral TabletSYeb7196aa-898b-48d3-a6c7-8b52ff740b303

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3620-05009036200010 TABLET in 1 BOTTLE (50090-3620-0) 10 tablet2018-11-150000-00-00NoNoCurrent
50090-3620-15009036200120 TABLET in 1 BOTTLE, PLASTIC (50090-3620-1) 20 tablet2016-02-010000-00-00NoNoCurrent
50090-3620-35009036200315 TABLET in 1 BOTTLE, PLASTIC (50090-3620-3) 15 tablet2016-02-010000-00-00NoNoCurrent
50090-3620-45009036200430 TABLET in 1 BOTTLE, PLASTIC (50090-3620-4) 30 tablet2016-02-010000-00-00NoNoCurrent
50090-3620-55009036200590 TABLET in 1 BOTTLE, PLASTIC (50090-3620-5) 90 tablet2016-02-010000-00-00NoNoCurrent
50090-3620-6500903620067 TABLET in 1 BOTTLE, PLASTIC (50090-3620-6) 7 tablet2016-02-010000-00-00NoNoCurrent