FDA.reportPublic FDA data

Loratadine 10mg

Product NDC
69168-475
Requested package NDC
69168-475-17
11-digit product format
691680475
Labeler code
69168
Product ID
69168-475_1307fce8-d753-4df5-90f0-a902befdfe35
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine 10mg
Dosage form
TABLET
Route
ORAL
Labeler
Allegiant Health
Application
ANDA211718
Marketing category
ANDA
Marketing start
2025-03-18
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A211718-001LORATADINELORATADINE10MGTABLET / ORAL2023-07-28

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A211718-001LORATADINE10MGTABLET / ORAL2023-07-2884e616aacf4f…
2026-08-18 06:07:402026-07A211718-001LORATADINE10MGTABLET / ORAL2023-07-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211718-001LORATADINE10MGTABLET / ORAL2023-07-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211718-001LORATADINE10MGTABLET / ORAL2023-07-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A211718-001LORATADINE10MGTABLET / ORAL2023-07-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211718-001LORATADINE10MGTABLET / ORAL2023-07-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211718-001LORATADINE10MGTABLET / ORAL2023-07-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211718-001LORATADINE10MGTABLET / ORAL2023-07-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211718-001LORATADINE10MGTABLET / ORAL2023-07-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211718-001LORATADINE10MGTABLET / ORAL2023-07-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211718-001LORATADINE10MGTABLET / ORAL2023-07-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211718-001LORATADINE10MGTABLET / ORAL2023-07-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211718-001LORATADINE10MGTABLET / ORAL2023-07-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211718-001LORATADINE10MGTABLET / ORAL2023-07-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211718-001LORATADINE10MGTABLET / ORAL2023-07-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211718-001LORATADINE10MGTABLET / ORAL2023-07-288072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211718-001LORATADINE10MGTABLET / ORAL2023-07-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211718-001LORATADINE10MGTABLET / ORAL2023-07-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211718-001LORATADINE10MGTABLET / ORAL2023-07-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211718-001LORATADINE10MGTABLET / ORAL2023-07-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211718-001LORATADINE10MGTABLET / ORAL2023-07-289b2671bbb829…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211718-001LORATADINE10MGTABLET / ORAL2023-07-28a50c72e98297…

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 10mg
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
f0db3a13-43e6-4243-9a3a-7808ddd005e1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-475-02Loratadine 10mg150 in 1 BOTTLETABLET15010
69168-475-05Loratadine 10mg500 in 1 BOTTLETABLET50010
69168-475-08Loratadine 10mg1 in 1 CARTONTABLET110
69168-475-08Loratadine 10mg5 in 1 BLISTER PACKTABLET510
69168-475-09Loratadine 10mg10 in 1 BLISTER PACKTABLET1010
69168-475-09Loratadine 10mg1 in 1 CARTONTABLET110
69168-475-17Loratadine 10mg300 in 1 BOTTLETABLET30010
69168-475-30Loratadine 10mg1 in 1 CARTONTABLET110
69168-475-30Loratadine 10mg30 in 1 BOTTLETABLET3010
69168-475-60Loratadine 10mg60 in 1 BOTTLETABLET6010
69168-475-99Loratadine 10mg365 in 1 BOTTLETABLET36510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-475ALLERGY RELIEF (LORATADINE) TABLET LORATADINE 10MG TABLET [ALLEGIANT HEALTH]8Current NDC, 11 package rows20250321_f0db3a13-43e6-4243-9a3a-7808ddd005e1.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 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LoratadineLORATADINEPreferred Pharmaceuticals Inc.d778c4d2-184a-4dc8-9351-66d81d0618f22026-05-28WarningsExact identifier
application applno (ANDA): 211718
application number: ANDA211718
LoratadineLORATADINEAvPAK52581dd2-9597-35cb-e063-6294a90a36c72026-05-21WarningsExact identifier
application applno (ANDA): 211718
application number: ANDA211718
LoratadineLORATADINEBryant Ranch Prepackbaad51cd-daa0-4920-a6d5-2faaaaea79562025-06-18WarningsExact identifier
application applno (ANDA): 211718
application number: ANDA211718
LoratadineLORATADINEBryant Ranch Prepack7f97595b-9df7-4834-82f0-5e4ce329c1182025-01-21WarningsExact identifier
application applno (ANDA): 211718
application number: ANDA211718
LoratadineLORATADINECamber Consumer Care Incd57da4bd-af37-414a-a50c-e80d2bb283142023-09-08WarningsExact identifier
application applno (ANDA): 211718
application number: ANDA211718
Allergy ReliefLORATADINEAllegiant Healthf0db3a13-43e6-4243-9a3a-7808ddd005e12020-06-16WarningsExact identifier
application applno (ANDA): 211718
application number: ANDA211718
ndc (package): 69168-475-17
ndc (product): 69168-475
ndc11 (package): 69168047517

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSNf0db3a13-43e6-4243-9a3a-7808ddd005e110
311372loratadine 10 MG Oral TabletSCDf0db3a13-43e6-4243-9a3a-7808ddd005e110
311372loratadine 10 MG 24 HR Oral TabletSYf0db3a13-43e6-4243-9a3a-7808ddd005e110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69168-475-1769168047517300 TABLET in 1 BOTTLE (69168-475-17) 300 tablet2025-09-30NoNoCurrent