Loratadine

Product NDC: 71335-2391
Requested package NDC: 71335-2391-8
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211718-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2023-07-28

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`a50c72e98297…`

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
Ingredient	Strength
LORATADINE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7AJO3BO7QN	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311372	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
baad51cd-daa0-4920-a6d5-2faaaaea7956	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-2391-1	Loratadine	20 in 1 BOTTLE	TABLET	20	1
71335-2391-2	Loratadine	30 in 1 BOTTLE	TABLET	30	1
71335-2391-3	Loratadine	60 in 1 BOTTLE	TABLET	60	1
71335-2391-4	Loratadine	14 in 1 BOTTLE	TABLET	14	1
71335-2391-5	Loratadine	10 in 1 BOTTLE	TABLET	10	1
71335-2391-6	Loratadine	90 in 1 BOTTLE	TABLET	90	1
71335-2391-7	Loratadine	28 in 1 BOTTLE	TABLET	28	1
71335-2391-8	Loratadine	15 in 1 BOTTLE	TABLET	15	1
71335-2391-9	Loratadine	100 in 1 BOTTLE	TABLET	100	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-2391-1	EA - Each	71335-2391	4fc06ac6-23bc-471d-bbdf-1cbf50ce3e2c	1	2026-01-08
71335-2391-2	EA - Each	71335-2391	6c035bd3-b72c-40ef-9462-42dc3e65c1a8	1	2025-11-13

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loratadine	LORATADINE	Preferred Pharmaceuticals Inc.	d778c4d2-184a-4dc8-9351-66d81d0618f2	2026-05-28	Warnings	Exact identifier application applno (ANDA): 211718 application number: ANDA211718
Loratadine	LORATADINE	AvPAK	52581dd2-9597-35cb-e063-6294a90a36c7	2026-05-21	Warnings	Exact identifier application applno (ANDA): 211718 application number: ANDA211718
Loratadine	LORATADINE	Bryant Ranch Prepack	baad51cd-daa0-4920-a6d5-2faaaaea7956	2025-06-18	Warnings	Exact identifier application applno (ANDA): 211718 application number: ANDA211718 ndc (package): 71335-2391-8 ndc (product): 71335-2391 ndc11 (package): 71335239108
Loratadine	LORATADINE	Bryant Ranch Prepack	7f97595b-9df7-4834-82f0-5e4ce329c118	2025-01-21	Warnings	Exact identifier application applno (ANDA): 211718 application number: ANDA211718
Loratadine	LORATADINE	Camber Consumer Care Inc	d57da4bd-af37-414a-a50c-e80d2bb28314	2023-09-08	Warnings	Exact identifier application applno (ANDA): 211718 application number: ANDA211718
Allergy Relief	LORATADINE	Allegiant Health	f0db3a13-43e6-4243-9a3a-7808ddd005e1	2020-06-16	Warnings	Exact identifier application applno (ANDA): 211718 application number: ANDA211718

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7AJO3BO7QN	LORATADINE	79794-75-5	LORATADINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311372	loratadine 10 MG 24HR Oral Tablet	PSN	baad51cd-daa0-4920-a6d5-2faaaaea7956	1
311372	loratadine 10 MG Oral Tablet	SCD	baad51cd-daa0-4920-a6d5-2faaaaea7956	1
311372	loratadine 10 MG 24 HR Oral Tablet	SY	baad51cd-daa0-4920-a6d5-2faaaaea7956	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-2391-8	71335239108	15 TABLET in 1 BOTTLE (71335-2391-8)	15 tablet	2025-06-18	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Loratadine tablets USP, 10mg/antihistamine	Bryant Ranch Prepack	2025-06-18	HUMAN OTC DRUG LABEL	1