FDA.reportPublic FDA data

Loratadine 10mg

Product NDC
25000-092
Requested package NDC
25000-092-81
11-digit product format
250000092
Labeler code
25000
Product ID
25000-092_aa667b5f-a4ac-4129-bae9-f9c1de776629
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine 10mg
Dosage form
TABLET
Route
ORAL
Labeler
MARKSANS PHARMA LIMITED
Application
ANDA219223
Marketing category
ANDA
Marketing start
2024-11-21
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 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
A219223-001LORATADINELORATADINE10MGTABLET / ORAL2024-11-21

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A219223-001LORATADINE10MGTABLET / ORAL2024-11-21c2088c7a36db…
2026-09-14 22:38:342026-08A219223-001LORATADINE10MGTABLET / ORAL2024-11-2184e616aacf4f…
2026-08-18 06:07:402026-07A219223-001LORATADINE10MGTABLET / ORAL2024-11-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219223-001LORATADINE10MGTABLET / ORAL2024-11-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219223-001LORATADINE10MGTABLET / ORAL2024-11-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A219223-001LORATADINE10MGTABLET / ORAL2024-11-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A219223-001LORATADINE10MGTABLET / ORAL2024-11-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A219223-001LORATADINE10MGTABLET / ORAL2024-11-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A219223-001LORATADINE10MGTABLET / ORAL2024-11-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A219223-001LORATADINE10MGTABLET / ORAL2024-11-212680178bc6a6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219223-001LORATADINE10MGTABLET / ORAL2024-11-21a50c72e98297…

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
3360d02d-612d-4cc5-acc9-2cc93713c387Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25000-092-03Loratadine 10mg1 in 1 CARTONTABLET14
25000-092-03Loratadine 10mg30 in 1 BOTTLETABLET304
25000-092-79Loratadine 10mg1 in 1 CARTONTABLET14
25000-092-79Loratadine 10mg150 in 1 BOTTLETABLET1504
25000-092-80Loratadine 10mg365 in 1 BOTTLETABLET3654
25000-092-81Loratadine 10mg7 in 1 BLISTER PACKTABLET74
25000-092-81Loratadine 10mg2 in 1 CARTONTABLET24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25000-092LORATADINE 10MG TABLET [MARKSANS PHARMA LIMITED]4Current NDC, 7 package rows20241127_3360d02d-612d-4cc5-acc9-2cc93713c387.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loratadine 10 mgLORATADINE TABLETS USP, 10 MGTIME CAP LABORATORIES, INC.2c80ea14-8490-4d26-e063-6294a90aecf02025-01-24WarningsExact identifier
application applno (ANDA): 219223
application number: ANDA219223
Loratadine 10mgLORATADINE 10MGMARKSANS PHARMA LIMITED3360d02d-612d-4cc5-acc9-2cc93713c3872024-11-25WarningsExact identifier
application applno (ANDA): 219223
application number: ANDA219223
ndc (package): 25000-092-81
ndc (product): 25000-092
ndc11 (package): 25000009281

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN3360d02d-612d-4cc5-acc9-2cc93713c3874
311372loratadine 10 MG Oral TabletSCD3360d02d-612d-4cc5-acc9-2cc93713c3874
311372loratadine 10 MG 24 HR Oral TabletSY3360d02d-612d-4cc5-acc9-2cc93713c3874

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25000-092-81250000092812 BLISTER PACK in 1 CARTON (25000-092-81) / 7 TABLET in 1 BLISTER PACK2 blister pack2024-11-21NoNoCurrent