FDA.reportPublic FDA data

Loratadine

Product NDC
50268-777
11-digit product format
502680777
Labeler code
50268
Product ID
50268-777_52581d32-443e-9534-e063-6394a90a28a0
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA211718
Marketing category
ANDA
Marketing start
2026-05-21
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
Listing expiration
2027-12-31

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
52581dd2-9597-35cb-e063-6294a90a36c7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-777-01Loratadine1 in 1 BOXTABLET11
50268-777-11Loratadine1 in 1 BLISTER PACKTABLET11

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
ndc (product): 50268-777
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN52581dd2-9597-35cb-e063-6294a90a36c71
311372loratadine 10 MG Oral TabletSCD52581dd2-9597-35cb-e063-6294a90a36c71
311372loratadine 10 MG 24 HR Oral TabletSY52581dd2-9597-35cb-e063-6294a90a36c71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50268-777-01502680777011 BLISTER PACK in 1 BOX (50268-777-01) / 1 TABLET in 1 BLISTER PACK (50268-777-11) 1 blister pack2026-05-21NoNoCurrent
50268-777-11502680777111 in 1 BLISTER PACKHistorical