FDA.reportPublic FDA data

Loratadine Allergy Relief

Product NDC
63629-7772
11-digit product format
636297772
Labeler code
63629
Product ID
63629-7772_8938739d-6c7a-4e91-b901-420561662ca8
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076134
Marketing category
ANDA
Marketing start
2017-11-01
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63629-7772-5834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63629-7772-8834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63629-7772-1834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63629-7772-9834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63629-7772-3834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63629-7772-7834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63629-7772-4834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63629-7772-6834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63629-7772-2834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63629-7772-51332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63629-7772-81332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63629-7772-11332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63629-7772-91332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63629-7772-31332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63629-7772-71332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63629-7772-41332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63629-7772-61332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63629-7772-21332a3947898…d4bfe170f9cd…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-7772-29bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-7772-89bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-7772-99bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-7772-19bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-7772-69bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-7772-59bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-7772-39bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-7772-79bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-7772-49bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A076134-001LORATADINELORATADINE10MGTABLET / ORAL2003-08-18

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A076134-001LORATADINE10MGTABLET / ORAL2003-08-18c2088c7a36db…
2026-09-14 22:38:342026-08A076134-001LORATADINE10MGTABLET / ORAL2003-08-1884e616aacf4f…
2026-08-18 06:07:402026-07A076134-001LORATADINE10MGTABLET / ORAL2003-08-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076134-001LORATADINE10MGTABLET / ORAL2003-08-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A076134-001LORATADINE10MGTABLET / ORAL2003-08-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076134-001LORATADINE10MGTABLET / ORAL2003-08-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076134-001LORATADINE10MGTABLET / ORAL2003-08-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076134-001LORATADINE10MGTABLET / ORAL2003-08-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076134-001LORATADINE10MGTABLET / ORAL2003-08-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076134-001LORATADINE10MGTABLET / ORAL2003-08-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076134-001LORATADINE10MGTABLET / ORAL2003-08-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076134-001LORATADINE10MGTABLET / ORAL2003-08-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076134-001LORATADINE10MGTABLET / ORAL2003-08-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076134-001LORATADINE10MGTABLET / ORAL2003-08-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076134-001LORATADINE10MGTABLET / ORAL2003-08-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076134-001LORATADINE10MGTABLET / ORAL2003-08-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076134-001LORATADINE10MGTABLET / ORAL2003-08-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076134-001LORATADINE10MGTABLET / ORAL2003-08-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076134-001LORATADINE10MGTABLET / ORAL2003-08-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076134-001LORATADINE10MGTABLET / ORAL2003-08-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A076134-001LORATADINE10MGTABLET / ORAL2003-08-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076134-001LORATADINE10MGTABLET / ORAL2003-08-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-183f01610625f2…
2019-09-15 20:21 UTC2019-09A076134-001LORATADINE10MGTABLET / ORAL2003-08-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A076134-001LORATADINE10MGTABLET / ORAL2003-08-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076134-001LORATADINE10MGTABLET / ORAL2003-08-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076134-001LORATADINE10MGTABLET / ORAL2003-08-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076134-001LORATADINE10MGTABLET / ORAL2003-08-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076134-001LORATADINE10MGTABLET / ORAL2003-08-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076134-001LORATADINE10MGTABLET / ORAL2003-08-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076134-001LORATADINE10MGTABLET / ORAL2003-08-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A076134-001LORATADINE10MGTABLET / ORAL2003-08-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A076134-001LORATADINE10MGTABLET / ORAL2003-08-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076134-001LORATADINE10MGTABLET / ORAL2003-08-183a93d1ddd44b…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Loratadine Allergy Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7AJO3BO7QNInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311372Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
94642b79-f91a-429f-87f4-dad326d4f3edAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-7772-12024-05-14Loratadine Allergy Relief
63629-7772-22024-05-14Loratadine Allergy Relief
63629-7772-32024-05-14Loratadine Allergy Relief
63629-7772-42024-05-14Loratadine Allergy Relief
63629-7772-52024-05-14Loratadine Allergy Relief
63629-7772-62024-05-14Loratadine Allergy Relief
63629-7772-72024-05-14Loratadine Allergy Relief
63629-7772-82024-05-14Loratadine Allergy Relief
63629-7772-92024-05-14Loratadine Allergy Relief
63629-7772-12024-01-30Loratadine Allergy Relief
63629-7772-22024-01-30Loratadine Allergy Relief
63629-7772-32024-01-30Loratadine Allergy Relief
63629-7772-42024-01-30Loratadine Allergy Relief
63629-7772-52024-01-30Loratadine Allergy Relief
63629-7772-62024-01-30Loratadine Allergy Relief
63629-7772-72024-01-30Loratadine Allergy Relief
63629-7772-82024-01-30Loratadine Allergy Relief
63629-7772-92024-01-30Loratadine Allergy Relief
63629-7772-12020-10-12Loratadine Allergy Relief
63629-7772-22020-10-12Loratadine Allergy Relief
63629-7772-32020-10-12Loratadine Allergy Relief
63629-7772-42020-10-12Loratadine Allergy Relief
63629-7772-52020-10-12Loratadine Allergy Relief
63629-7772-62020-10-12Loratadine Allergy Relief
63629-7772-72020-10-12Loratadine Allergy Relief
63629-7772-82020-10-12Loratadine Allergy Relief
63629-7772-92020-10-12Loratadine Allergy Relief
63629-7772-12020-01-31Loratadine Allergy Relief
63629-7772-22020-01-31Loratadine Allergy Relief
63629-7772-32020-01-31Loratadine Allergy Relief
63629-7772-42020-01-31Loratadine Allergy Relief
63629-7772-52020-01-31Loratadine Allergy Relief
63629-7772-62020-01-31Loratadine Allergy Relief
63629-7772-72020-01-31Loratadine Allergy Relief
63629-7772-82020-01-31Loratadine Allergy Relief
63629-7772-92020-01-31Loratadine Allergy Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-7772-1Loratadine Allergy Relief20 in 1 BOTTLETABLET206
63629-7772-2Loratadine Allergy Relief30 in 1 BOTTLETABLET306
63629-7772-3Loratadine Allergy Relief60 in 1 BOTTLETABLET606
63629-7772-4Loratadine Allergy Relief14 in 1 BOTTLETABLET146
63629-7772-5Loratadine Allergy Relief10 in 1 BOTTLETABLET106
63629-7772-6Loratadine Allergy Relief90 in 1 BOTTLETABLET906
63629-7772-7Loratadine Allergy Relief28 in 1 BOTTLETABLET286
63629-7772-8Loratadine Allergy Relief15 in 1 BOTTLETABLET156
63629-7772-9Loratadine Allergy Relief100 in 1 BOTTLETABLET1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7772LORATADINE ALLERGY RELIEF (LORATADINE) TABLET [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 9 package rows20240516_94642b79-f91a-429f-87f4-dad326d4f3ed.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 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LoratadineLORATADINEChain Drug Marketing Association Inc.b4edf5b1-398d-405a-8a42-76044b31ebb72018-08-27WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
Loratadine Allergy ReliefLORATADINEHEB6703e4f3-e9b8-4c70-9085-3d6ac0d7fbda2018-05-14WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
LoratadineLORATADINEPremier Value778a6979-ea47-4381-8c40-84b3c2325a7e2018-01-11WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
Loratadine Allergy ReliefLORATADINELIDL US, LLC11bc027c-d28d-45f0-a4cb-24a3834a69952018-01-09WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN94642b79-f91a-429f-87f4-dad326d4f3ed6
311372loratadine 10 MG Oral TabletSCD94642b79-f91a-429f-87f4-dad326d4f3ed6
311372loratadine 10 MG 24 HR Oral TabletSY94642b79-f91a-429f-87f4-dad326d4f3ed6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7772-16362977720120 TABLET in 1 BOTTLE (63629-7772-1) 20 tablet2018-07-300000-00-00NoNoCurrent
63629-7772-26362977720230 TABLET in 1 BOTTLE (63629-7772-2) 30 tablet2018-07-020000-00-00NoNoCurrent
63629-7772-36362977720360 TABLET in 1 BOTTLE (63629-7772-3) 60 tablet2019-11-220000-00-00NoNoCurrent
63629-7772-46362977720414 TABLET in 1 BOTTLE (63629-7772-4) 14 tablet2018-12-110000-00-00NoNoCurrent
63629-7772-56362977720510 TABLET in 1 BOTTLE (63629-7772-5) 10 tablet2018-07-050000-00-00NoNoCurrent
63629-7772-66362977720690 TABLET in 1 BOTTLE (63629-7772-6) 90 tablet2018-07-050000-00-00NoNoCurrent
63629-7772-76362977720728 TABLET in 1 BOTTLE (63629-7772-7) 28 tablet2024-04-030000-00-00NoNoCurrent
63629-7772-86362977720815 TABLET in 1 BOTTLE (63629-7772-8) 15 tablet2024-04-030000-00-00NoNoCurrent
63629-7772-963629777209100 TABLET in 1 BOTTLE (63629-7772-9) 100 tablet2019-06-210000-00-00NoNoCurrent