Alavert

Product NDC: 80070-120
11-digit product format: 800700120
Labeler code: 80070
Product ID: 80070-120_bd411eb7-c97c-47b5-a370-4e7d50838be7
Type: HUMAN OTC DRUG
Nonproprietary name: LORATADINE
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Foundation Consumer Brands
Application: NDA021375
Marketing category: NDA
Marketing start: 2021-04-02
Marketing end: 0000-00-00
Substance: LORATADINE
Active strength: 10 mg/1
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	80070-120		D	Discontinued by firm		2026-10-02
excluded package	package	80070-120	80070-120-60	D	Discontinued by firm		2026-10-02

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
N021375-001	ALAVERT	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL			2002-12-19

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.

Product history page 1 of 2 · 43 observed 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	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80070-120-60	AlavertAllergy	1 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	1		3
80070-120-60	AlavertAllergy	60 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	60		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80070-120	ALAVERT ALLERGY (LORATADINE) TABLET, ORALLY DISINTEGRATING [FOUNDATION CONSUMER BRANDS]	2	Legacy NDC, 2 package rows	20250112_039ea563-9796-4270-b84a-50dd25a9d976.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alavert Allergy	LORATADINE	Foundation Consumer Brands	039ea563-9796-4270-b84a-50dd25a9d976	2026-02-23	Warnings	Exact identifier application applno (NDA): 021375 application number: NDA021375 ndc (product): 80070-120
Alavert Allergy	LORATADINE	Foundation Consumer Brands	f741d1cf-0ecb-4405-8596-07af394537db	2026-02-23	Warnings	Exact identifier application applno (NDA): 021375 application number: NDA021375

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
351855	Alavert 10 MG 24HR Disintegrating Oral Tablet	PSN	039ea563-9796-4270-b84a-50dd25a9d976	3
311373	loratadine 10 MG 24HR Disintegrating Oral Tablet	PSN	039ea563-9796-4270-b84a-50dd25a9d976	3
351855	loratadine 10 MG Disintegrating Oral Tablet [Alavert]	SBD	039ea563-9796-4270-b84a-50dd25a9d976	3
311373	loratadine 10 MG Disintegrating Oral Tablet	SCD	039ea563-9796-4270-b84a-50dd25a9d976	3
351855	24 HR Alavert 10 MG Disintegrating Oral Tablet	SY	039ea563-9796-4270-b84a-50dd25a9d976	3
351855	Alavert 10 MG Disintegrating Oral Tablet	SY	039ea563-9796-4270-b84a-50dd25a9d976	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80070-120-60	80070012060	60 BLISTER PACK in 1 CARTON (80070-120-60) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	60 blister pack	2021-04-02	0000-00-00	No	No	Current