LORATADINE

Product NDC: 72888-029
11-digit product format: 728880029
Labeler code: 72888
Product ID: 72888-029_47a189dc-792d-a279-e063-6394a90a9adf
Type: HUMAN OTC DRUG
Nonproprietary name: LORATADINE
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Advagen Pharma Limited
Application: ANDA214280
Marketing category: ANDA
Marketing start: 2020-09-10
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A214280-001	LORATADINE	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL			2020-09-10

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	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214280-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-10	`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: 2027-12-31

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
311373	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
a5699a95-c0a7-43ea-9bab-bbfaba3c8aa5	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72888-029-09	LORATADINE	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10	2
72888-029-09	LORATADINE	1 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	1	2
72888-029-11	LORATADINE	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10	2
72888-029-11	LORATADINE	3 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	3	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72888-029-09	EA - Each	72888-029	02ce73c3-076c-4525-8a91-fd14e71dac47	1	2022-09-12
72888-029-11	EA - Each	72888-029	5299bbaa-521d-4535-8074-209b5dceb054	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72888-029	LORATADINE TABLET, ORALLY DISINTEGRATING [ADVAGEN PHARMA LIMITED]	1	Current NDC, Legacy NDC, 4 package rows	20200926_a5699a95-c0a7-43ea-9bab-bbfaba3c8aa5.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LORATADINE	LORATADINE	Advagen Pharma Limited	a5699a95-c0a7-43ea-9bab-bbfaba3c8aa5	2026-01-05		Exact identifier application applno (ANDA): 214280 application number: ANDA214280 ndc (product): 72888-029

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
311373	loratadine 10 MG 24HR Disintegrating Oral Tablet	PSN	a5699a95-c0a7-43ea-9bab-bbfaba3c8aa5	2
311373	loratadine 10 MG Disintegrating Oral Tablet	SCD	a5699a95-c0a7-43ea-9bab-bbfaba3c8aa5	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72888-029-09	72888002909	1 BLISTER PACK in 1 CARTON (72888-029-09) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	1 blister pack	2020-09-10	0000-00-00	No	No	Current
72888-029-11	72888002911	3 BLISTER PACK in 1 CARTON (72888-029-11) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	3 blister pack	2020-09-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LORATADINE - Advagen Pharma Limited \| Rubicon Research Limited	Advagen Pharma Limited \| Rubicon Research Limited	2026-01-05	HUMAN OTC DRUG LABEL	2