Loratadine

Product NDC: 69230-323
11-digit product format: 692300323
Labeler code: 69230
Product ID: 69230-323_04d9c5a8-1f42-f7c0-e063-6294a90a92ae
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: TABLET
Route: ORAL
Labeler: Camber Consumer Care Inc
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 1.

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
2026-02-19 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…`

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
d57da4bd-af37-414a-a50c-e80d2bb28314	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69230-323-01	Loratadine	10 in 1 CARTON	TABLET	10	2
69230-323-10	Loratadine	1000 in 1 BOTTLE	TABLET	1000	2
69230-323-30	Loratadine	30 in 1 BOTTLE	TABLET	30	2
69230-323-30	Loratadine	1 in 1 CARTON	TABLET	1	2
69230-323-31	Loratadine	108 in 1 BOTTLE	TABLET	108	2
69230-323-31	Loratadine	1 in 1 CARTON	TABLET	1	2
69230-323-32	Loratadine	10 in 1 BLISTER PACK	TABLET	10	2
69230-323-33	Loratadine	1 in 1 CARTON	TABLET	1	2
69230-323-33	Loratadine	100 in 1 BOTTLE	TABLET	100	2
69230-323-34	Loratadine	300 in 1 BOTTLE	TABLET	300	2
69230-323-34	Loratadine	1 in 1 CARTON	TABLET	1	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69230-323-30	EA - Each	69230-323	201bb70e-fb9b-4500-b71b-0f6a81ae4496	1	2024-04-05
69230-323-33	EA - Each	69230-323	09fff6b2-e4ce-4023-a5aa-e9130a7fc067	1	2024-04-05
69230-323-34	EA - Each	69230-323	6fb9ba44-5272-4816-918a-5e1b0ef886c1	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69230-323	LORATADINE (LORATADINE) TABLET [CAMBER CONSUMER CARE INC]	2	Current NDC, 11 package rows	20230910_d57da4bd-af37-414a-a50c-e80d2bb28314.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
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
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 ndc (product): 69230-323
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	d778c4d2-184a-4dc8-9351-66d81d0618f2	3
311372	loratadine 10 MG Oral Tablet	SCD	d778c4d2-184a-4dc8-9351-66d81d0618f2	3
311372	loratadine 10 MG 24 HR Oral Tablet	SY	d778c4d2-184a-4dc8-9351-66d81d0618f2	3
311372	loratadine 10 MG 24HR Oral Tablet	PSN	d57da4bd-af37-414a-a50c-e80d2bb28314	2
311372	loratadine 10 MG Oral Tablet	SCD	d57da4bd-af37-414a-a50c-e80d2bb28314	2
311372	loratadine 10 MG 24 HR Oral Tablet	SY	d57da4bd-af37-414a-a50c-e80d2bb28314	2
311372	loratadine 10 MG 24HR Oral Tablet	PSN	52581dd2-9597-35cb-e063-6294a90a36c7	1
311372	loratadine 10 MG 24HR Oral Tablet	PSN	7f97595b-9df7-4834-82f0-5e4ce329c118	1
311372	loratadine 10 MG 24HR Oral Tablet	PSN	baad51cd-daa0-4920-a6d5-2faaaaea7956	1
311372	loratadine 10 MG Oral Tablet	SCD	52581dd2-9597-35cb-e063-6294a90a36c7	1
311372	loratadine 10 MG Oral Tablet	SCD	7f97595b-9df7-4834-82f0-5e4ce329c118	1
311372	loratadine 10 MG Oral Tablet	SCD	baad51cd-daa0-4920-a6d5-2faaaaea7956	1
311372	loratadine 10 MG 24 HR Oral Tablet	SY	52581dd2-9597-35cb-e063-6294a90a36c7	1
311372	loratadine 10 MG 24 HR Oral Tablet	SY	7f97595b-9df7-4834-82f0-5e4ce329c118	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
69230-323-01	69230032301	10 BLISTER PACK in 1 CARTON (69230-323-01) / 10 TABLET in 1 BLISTER PACK (69230-323-32)	10 blister pack	2023-07-28	No	No	Current
69230-323-10	69230032310	1000 TABLET in 1 BOTTLE (69230-323-10)	1000 tablet	2023-07-28	No	No	Current
69230-323-30	69230032330	1 BOTTLE in 1 CARTON (69230-323-30) / 30 TABLET in 1 BOTTLE	1 bottle	2023-07-28	No	No	Current
69230-323-31	69230032331	1 BOTTLE in 1 CARTON (69230-323-31) / 108 TABLET in 1 BOTTLE	1 bottle	2023-07-28	No	No	Current
69230-323-32	69230032332	10 in 1 BLISTER PACK					Historical
69230-323-33	69230032333	1 BOTTLE in 1 CARTON (69230-323-33) / 100 TABLET in 1 BOTTLE	1 bottle	2023-07-28	No	No	Current
69230-323-34	69230032334	1 BOTTLE in 1 CARTON (69230-323-34) / 300 TABLET in 1 BOTTLE	1 bottle	2023-07-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Loratadine tablets USP, 10mg/antihistamine	Preferred Pharmaceuticals Inc.	2026-05-28	HUMAN OTC DRUG LABEL	3
Loratadine tablets USP, 10mg/antihistamine	AvPAK	2026-05-21	HUMAN OTC DRUG LABEL	1
Loratadine tablets USP, 10mg/antihistamine	Bryant Ranch Prepack	2025-06-18	HUMAN OTC DRUG LABEL	1
Loratadine tablets USP, 10mg/antihistamine	Bryant Ranch Prepack	2025-01-21	HUMAN PRESCRIPTION DRUG LABEL	1
Loratadine tablets USP, 10mg/antihistamine	Camber Consumer Care Inc \| Annora Pharma Private Limited	2023-09-08	HUMAN OTC DRUG LABEL	2