FDA.reportPublic FDA data

LORATADINE

Product NDC
69452-211
11-digit product format
694520211
Labeler code
69452
Product ID
69452-211_932678d1-e6bf-4154-ac00-b6b9c9fbd16e
Type
HUMAN OTC DRUG
Nonproprietary name
LORATADINE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA202538
Marketing category
ANDA
Marketing start
2019-03-01
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
A202538-001LORATADINELORATADINE10MGCAPSULE / ORAL2018-12-21

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 22:38:342026-08A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-2184e616aacf4f…
2026-08-18 06:07:402026-07A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-213f01610625f2…
2019-09-15 20:21 UTC2019-09A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21f41ea6bd6efb…

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
59bebce3-2b82-4521-a796-2d4c83bcf669Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69452-211-03LORATADINE5 in 1 BOTTLECAPSULE, LIQUID FILLED52
69452-211-03LORATADINE1 in 1 CARTONCAPSULE, LIQUID FILLED12
69452-211-07LORATADINE10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED102
69452-211-07LORATADINE1 in 1 CARTONCAPSULE, LIQUID FILLED12
69452-211-16LORATADINE50 in 1 BOTTLECAPSULE, LIQUID FILLED502
69452-211-16LORATADINE1 in 1 CARTONCAPSULE, LIQUID FILLED12
69452-211-26LORATADINE200 in 1 BOTTLECAPSULE, LIQUID FILLED2002
69452-211-26LORATADINE1 in 1 CARTONCAPSULE, LIQUID FILLED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-211LORATADINE CAPSULE, LIQUID FILLED [BIONPHARMA INC.]2Current NDC, Legacy NDC, 8 package rows20190301_59bebce3-2b82-4521-a796-2d4c83bcf669.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
dg health allergy reliefLORATADINEDolgencorp Inc086a0a53-7092-4dc8-9c5e-0bd78337fedf2025-03-11WarningsExact identifier
application applno (ANDA): 202538
application number: ANDA202538
allergy reliefLORATADINEMeijer, Inc.14f3d1a2-eda7-432a-8fe0-5437b95bdde62025-02-14WarningsExact identifier
application applno (ANDA): 202538
application number: ANDA202538
topcare allergy reliefLORATADINETopco Associates LLC5cc2e469-9080-4beb-804d-187fc335ccdc2025-02-10WarningsExact identifier
application applno (ANDA): 202538
application number: ANDA202538
LORATADINELORATADINEBionpharma Inc.4fa705fb-859e-4046-b153-a8338c50a97d2024-12-23WarningsExact identifier
application applno (ANDA): 202538
application number: ANDA202538
Basic Care Allergy ReliefLORATADINEAmazon.com Services LLC2a834b33-5759-4e54-9adc-379310656dee2020-08-19WarningsExact identifier
application applno (ANDA): 202538
application number: ANDA202538
LORATADINELORATADINEBionpharma Inc.59bebce3-2b82-4521-a796-2d4c83bcf6692019-01-08WarningsExact identifier
application applno (ANDA): 202538
application number: ANDA202538
ndc (product): 69452-211

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828269loratadine 10 MG 24HR Oral CapsulePSN59bebce3-2b82-4521-a796-2d4c83bcf6692
828269loratadine 10 MG Oral CapsuleSCD59bebce3-2b82-4521-a796-2d4c83bcf6692
828269loratadine 10 MG 24HR Oral CapsuleSY59bebce3-2b82-4521-a796-2d4c83bcf6692

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69452-211-03694520211031 BOTTLE in 1 CARTON (69452-211-03) / 5 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2019-03-010000-00-00NoNoCurrent
69452-211-07694520211071 BLISTER PACK in 1 CARTON (69452-211-07) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2019-03-010000-00-00NoNoCurrent
69452-211-16694520211161 BOTTLE in 1 CARTON (69452-211-16) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2019-03-010000-00-00NoNoCurrent
69452-211-26694520211261 BOTTLE in 1 CARTON (69452-211-26) / 200 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2019-03-010000-00-00NoNoCurrent