Claritin

Product NDC
11523-7200
Requested package NDC
11523-7200-1
11-digit product format
115237200
Labeler code
11523
Product ID
11523-7200_4a2b0359-b6f2-ddf9-e063-6294a90aed99
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
NDA021952
Marketing category
NDA
Marketing start
2008-06-16
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11523-720011523-7200-1IInactivated by FDA2026-08-17

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11523-720011523-7200-1IInactivated by FDAexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11523-720011523-7200-1IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N021952-001CLARITINLORATADINE10MGCAPSULE / ORALRLD, RS2008-06-16

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-1687673890dc5c…
2021-03-12 10:30 UTC2021-03N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-163f01610625f2…
2019-09-15 20:21 UTC2019-09N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-16b00525d2431f…
2019-07-19 19:46 UTC2019-07N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-163f0d92c62455…
2023-05-13 08:27 UTC2023-05N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-16053a50430f4f…
2023-01-26 05:58 UTC2023-01N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021952-001CLARITIN10MGCAPSULE / ORALRLD, RS2008-06-16e64feba35796…

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-7200-1ClaritinLiqui-Gels1 in 1 CARTONCAPSULE, LIQUID FILLED113
11523-7200-1ClaritinLiqui-Gels10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1013
11523-7200-2ClaritinLiqui-Gels8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED813
11523-7200-2ClaritinLiqui-Gels3 in 1 CARTONCAPSULE, LIQUID FILLED313
11523-7200-3ClaritinLiqui-Gels10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1013
11523-7200-3ClaritinLiqui-Gels4 in 1 CARTONCAPSULE, LIQUID FILLED413
11523-7200-4ClaritinLiqui-Gels10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1013
11523-7200-4ClaritinLiqui-Gels7 in 1 CARTONCAPSULE, LIQUID FILLED713
11523-7200-5ClaritinLiqui-Gels1 in 1 POUCHCAPSULE, LIQUID FILLED113
11523-7200-6ClaritinLiqui-Gels10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1013
11523-7200-6ClaritinLiqui-Gels3 in 1 CARTONCAPSULE, LIQUID FILLED313
11523-7200-7ClaritinLiqui-Gels9 in 1 BLISTER PACKCAPSULE, LIQUID FILLED913
11523-7200-7ClaritinLiqui-Gels5 in 1 CARTONCAPSULE, LIQUID FILLED513
11523-7200-8ClaritinLiqui-Gels10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1013
11523-7200-8ClaritinLiqui-Gels4 in 1 CARTONCAPSULE, LIQUID FILLED413
11523-7200-9ClaritinLiqui-Gels10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1013
11523-7200-9ClaritinLiqui-Gels6 in 1 CARTONCAPSULE, LIQUID FILLED613

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-7200-1EA - Each11523-7200aadf47aa-87c1-425b-a7f6-67866160edcb12013-02-13
11523-7200-2EA - Each11523-72007facd762-a51d-45fa-94f1-ce08487f429c12013-02-13
11523-7200-3EA - Each11523-720076a5d6cf-4345-48d9-8064-dfa7d481a89812013-02-13
11523-7200-6EA - Each11523-7200bae274e3-4d2c-4f8a-b379-0ac97ba5a8cd12015-03-03
11523-7200-7EA - Each11523-7200c435ae2a-e01a-4fc3-89c0-5b1f9b83e23112015-10-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-7200CLARITIN LIQUI-GELS (LORATADINE) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC.]12Current NDC, Legacy NDC, 17 package rows20240217_8e14b61f-faf6-43a8-a080-75f64514217a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836338Claritin Liqui-Gels 10 MG 24HR Oral CapsulePSN8e14b61f-faf6-43a8-a080-75f64514217a13
828269loratadine 10 MG 24HR Oral CapsulePSN8e14b61f-faf6-43a8-a080-75f64514217a13
836338loratadine 10 MG Oral Capsule [Claritin]SBD8e14b61f-faf6-43a8-a080-75f64514217a13
828269loratadine 10 MG Oral CapsuleSCD8e14b61f-faf6-43a8-a080-75f64514217a13
836338Claritin 10 MG Oral CapsuleSY8e14b61f-faf6-43a8-a080-75f64514217a13
828269loratadine 10 MG 24HR Oral CapsuleSY8e14b61f-faf6-43a8-a080-75f64514217a13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-7200-1115237200011 BLISTER PACK in 1 CARTON (11523-7200-1) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2008-06-160000-00-00NoNoCurrent