FDA.reportPublic FDA data

Loratadine

Product NDC
58602-818
Requested package NDC
58602-818-84
11-digit product format
586020818
Labeler code
58602
Product ID
58602-818_cfa8d72c-3d1a-464c-b63a-b7b7525c1a3c
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA211900
Marketing category
ANDA
Marketing start
2023-03-24
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
A211900-001LORATADINELORATADINE10MGCAPSULE / ORAL2023-03-24

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-2484e616aacf4f…
2026-08-18 06:07:402026-07A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-248072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-24053a50430f4f…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-24a50c72e98297…

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
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
828269Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a057241d-a655-4847-9d2d-d45293f45d87Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-818-05Loratadine5 in 1 CARTONCAPSULE, LIQUID FILLED52
58602-818-05Loratadine10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED102
58602-818-08Loratadine4 in 1 CARTONCAPSULE, LIQUID FILLED42
58602-818-08Loratadine10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED102
58602-818-67Loratadine2 in 1 CARTONCAPSULE, LIQUID FILLED22
58602-818-67Loratadine10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED102
58602-818-83Loratadine1 in 1 CARTONCAPSULE, LIQUID FILLED12
58602-818-83Loratadine10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED102
58602-818-84Loratadine10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED102
58602-818-84Loratadine3 in 1 CARTONCAPSULE, LIQUID FILLED32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-818LORATADINE CAPSULE, LIQUID FILLED [AUROHEALTH LLC]2Current NDC, 10 package rows20241025_a057241d-a655-4847-9d2d-d45293f45d87.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LoratadineLORATADINEAurohealth LLCa057241d-a655-4847-9d2d-d45293f45d872024-10-23WarningsExact identifier
application applno (ANDA): 211900
application number: ANDA211900
ndc (package): 58602-818-84
ndc (product): 58602-818
ndc11 (package): 58602081884

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828269loratadine 10 MG 24HR Oral CapsulePSNa057241d-a655-4847-9d2d-d45293f45d872
828269loratadine 10 MG Oral CapsuleSCDa057241d-a655-4847-9d2d-d45293f45d872
828269loratadine 10 MG 24HR Oral CapsuleSYa057241d-a655-4847-9d2d-d45293f45d872

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58602-818-84586020818843 BLISTER PACK in 1 CARTON (58602-818-84) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK3 blister pack2023-03-24NoNoCurrent