FDA.reportPublic FDA data

Loratadine

Product NDC
71335-2391
11-digit product format
713352391
Labeler code
71335
Product ID
71335-2391_18eab889-2148-4233-aca0-38b185d5934d
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211718
Marketing category
ANDA
Marketing start
2023-07-28
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
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
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
baad51cd-daa0-4920-a6d5-2faaaaea7956Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2391-1Loratadine20 in 1 BOTTLETABLET201
71335-2391-2Loratadine30 in 1 BOTTLETABLET301
71335-2391-3Loratadine60 in 1 BOTTLETABLET601
71335-2391-4Loratadine14 in 1 BOTTLETABLET141
71335-2391-5Loratadine10 in 1 BOTTLETABLET101
71335-2391-6Loratadine90 in 1 BOTTLETABLET901
71335-2391-7Loratadine28 in 1 BOTTLETABLET281
71335-2391-8Loratadine15 in 1 BOTTLETABLET151
71335-2391-9Loratadine100 in 1 BOTTLETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2391-1EA - Each71335-23914fc06ac6-23bc-471d-bbdf-1cbf50ce3e2c12026-01-08
71335-2391-2EA - Each71335-23916c035bd3-b72c-40ef-9462-42dc3e65c1a812025-11-13

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
LoratadineLORATADINEBryant Ranch Prepackbaad51cd-daa0-4920-a6d5-2faaaaea79562025-06-18WarningsExact identifier
application applno (ANDA): 211718
application number: ANDA211718
ndc (product): 71335-2391
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 TabletPSNbaad51cd-daa0-4920-a6d5-2faaaaea79561
311372loratadine 10 MG Oral TabletSCDbaad51cd-daa0-4920-a6d5-2faaaaea79561
311372loratadine 10 MG 24 HR Oral TabletSYbaad51cd-daa0-4920-a6d5-2faaaaea79561

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2391-17133523910120 TABLET in 1 BOTTLE (71335-2391-1) 20 tablet2025-06-18NoNoCurrent
71335-2391-27133523910230 TABLET in 1 BOTTLE (71335-2391-2) 30 tablet2025-06-18NoNoCurrent
71335-2391-37133523910360 TABLET in 1 BOTTLE (71335-2391-3) 60 tablet2025-06-18NoNoCurrent
71335-2391-47133523910414 TABLET in 1 BOTTLE (71335-2391-4) 14 tablet2025-06-18NoNoCurrent
71335-2391-57133523910510 TABLET in 1 BOTTLE (71335-2391-5) 10 tablet2025-06-18NoNoCurrent
71335-2391-67133523910690 TABLET in 1 BOTTLE (71335-2391-6) 90 tablet2025-06-18NoNoCurrent
71335-2391-77133523910728 TABLET in 1 BOTTLE (71335-2391-7) 28 tablet2025-06-18NoNoCurrent
71335-2391-87133523910815 TABLET in 1 BOTTLE (71335-2391-8) 15 tablet2025-06-18NoNoCurrent
71335-2391-971335239109100 TABLET in 1 BOTTLE (71335-2391-9) 100 tablet2025-06-18NoNoCurrent