Alavert

Product NDC: 80070-110
11-digit product format: 800700110
Labeler code: 80070
Product ID: 80070-110_4b825a6b-4a48-2155-e063-6294a90abb14
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: 2026-10-31
Substance: LORATADINE
Active strength: 10 mg/1
NDC exclude flag: No
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	N021375-001	ALAVERT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2002-12-19	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Alavert
Brand name suffix: Allergy

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311373	Internal RxNorm lookup
351855	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
f741d1cf-0ecb-4405-8596-07af394537db	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80070-110-18	AlavertAllergy	1 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	1	4
80070-110-18	AlavertAllergy	18 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	18	4
80070-110-60	AlavertAllergy	60 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	60	4
80070-110-60	AlavertAllergy	1 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	1	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80070-110	ALAVERT ALLERGY (LORATADINE) TABLET, ORALLY DISINTEGRATING [FOUNDATION CONSUMER BRANDS]	2	Current NDC, Legacy NDC, 4 package rows	20250112_f741d1cf-0ecb-4405-8596-07af394537db.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
Alavert Allergy	LORATADINE	Foundation Consumer Brands	f741d1cf-0ecb-4405-8596-07af394537db	2026-02-23	Warnings	Exact identifier application applno (NDA): 021375 application number: NDA021375 ndc (product): 80070-110

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	f741d1cf-0ecb-4405-8596-07af394537db	4
311373	loratadine 10 MG 24HR Disintegrating Oral Tablet	PSN	f741d1cf-0ecb-4405-8596-07af394537db	4
351855	loratadine 10 MG Disintegrating Oral Tablet [Alavert]	SBD	f741d1cf-0ecb-4405-8596-07af394537db	4
311373	loratadine 10 MG Disintegrating Oral Tablet	SCD	f741d1cf-0ecb-4405-8596-07af394537db	4
351855	24 HR Alavert 10 MG Disintegrating Oral Tablet	SY	f741d1cf-0ecb-4405-8596-07af394537db	4
351855	Alavert 10 MG Disintegrating Oral Tablet	SY	f741d1cf-0ecb-4405-8596-07af394537db	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80070-110-18	80070011018	18 BLISTER PACK in 1 CARTON (80070-110-18) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	18 blister pack	2021-04-02	2026-10-31	No	No	Current
80070-110-60	80070011060	60 BLISTER PACK in 1 CARTON (80070-110-60) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	60 blister pack	2021-04-02	2026-10-31	No	No	Current