FDA.reportPublic FDA data

Loratadine

Product NDC
68788-8605
11-digit product format
687888605
Labeler code
68788
Product ID
68788-8605_48cbeb9b-de13-4330-97b2-f87fb7e26cb9
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA211718
Marketing category
ANDA
Marketing start
2024-03-13
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
d778c4d2-184a-4dc8-9351-66d81d0618f2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8605-0Loratadine10 in 1 BOTTLETABLET102
68788-8605-1Loratadine14 in 1 BOTTLETABLET142
68788-8605-3Loratadine30 in 1 BOTTLETABLET302
68788-8605-5Loratadine15 in 1 BOTTLETABLET152
68788-8605-9Loratadine90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8605-0EA - Each68788-86054070bd29-6d7a-42a7-969c-22a4b0a3833712024-05-16
68788-8605-1EA - Each68788-86052954ff62-0a91-4e28-a0d7-8991f13807ef12024-05-16
68788-8605-3EA - Each68788-86058800d074-47ad-4891-b9a7-06d7c181060712024-05-16
68788-8605-5EA - Each68788-8605549aa5fa-8c50-47b0-b872-5d65ac6589c812024-05-16
68788-8605-9EA - Each68788-86052574982f-5494-4158-8795-59e74d4e665812024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8605LORATADINE TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 5 package rows20240322_d778c4d2-184a-4dc8-9351-66d81d0618f2.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
LoratadineLORATADINEPreferred Pharmaceuticals Inc.d778c4d2-184a-4dc8-9351-66d81d0618f22026-05-28WarningsExact identifier
application applno (ANDA): 211718
application number: ANDA211718
ndc (product): 68788-8605
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
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 TabletPSNd778c4d2-184a-4dc8-9351-66d81d0618f23
311372loratadine 10 MG Oral TabletSCDd778c4d2-184a-4dc8-9351-66d81d0618f23
311372loratadine 10 MG 24 HR Oral TabletSYd778c4d2-184a-4dc8-9351-66d81d0618f23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8605-06878886050010 TABLET in 1 BOTTLE (68788-8605-0) 10 tablet2024-03-13NoNoCurrent
68788-8605-16878886050114 TABLET in 1 BOTTLE (68788-8605-1) 14 tablet2024-03-13NoNoCurrent
68788-8605-36878886050330 TABLET in 1 BOTTLE (68788-8605-3) 30 tablet2024-03-13NoNoCurrent
68788-8605-56878886050515 TABLET in 1 BOTTLE (68788-8605-5) 15 tablet2024-03-13NoNoCurrent
68788-8605-96878886050990 TABLET in 1 BOTTLE (68788-8605-9) 90 tablet2024-03-13NoNoCurrent