ALAVERT ALLERGY

Product NDC: 0573-2620
Requested package NDC: 0573-2620-71
11-digit product format: 005732620
Labeler code: 0573
Product ID: 0573-2620_1ad9e626-55ca-4d43-b5ec-cc4d5bf19b07
Type: HUMAN OTC DRUG
Nonproprietary name: loratadine
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Application: NDA021375
Marketing category: NDA
Marketing start: 2002-12-19
Marketing end: 0000-00-00
Substance: LORATADINE
Active strength: 10 mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0573-2620	0573-2620-71	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0573-2620-01	2024-03-21	Drug Facts
0573-2620-19	2024-03-21	Drug Facts
0573-2620-65	2024-03-21	Drug Facts
0573-2620-71	2024-03-21	Drug Facts
0573-2620-01	2022-01-28	Drug Facts
0573-2620-19	2022-01-28	Drug Facts
0573-2620-65	2022-01-28	Drug Facts
0573-2620-71	2022-01-28	Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0573-2620-06	EA - Each	0573-2620	a426c267-75e5-4ee7-9ccb-d16f65916fb8	1	2013-02-11
0573-2620-19	EA - Each	0573-2620	803dfd04-b25f-4194-9168-06ac17863609	1	2012-07-24
0573-2620-30	EA - Each	0573-2620	7da8de28-0e7a-453a-81e4-006ec98783a2	1	2014-01-04
0573-2620-65	EA - Each	0573-2620	526cf195-dcb5-4dc1-ab35-715787f1e3d7	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LORATADINE	ACTIVE INGREDIENT	7AJO3BO7QN	ALAVERT ALLERGY (LORATADINE) TABLET, ORALLY DISINTEGRATING [PFIZER CONSUMER HEALTHCARE]	7
LORATADINE	ACTIVE MOIETY	7AJO3BO7QN	ALAVERT ALLERGY (LORATADINE) TABLET, ORALLY DISINTEGRATING [PFIZER CONSUMER HEALTHCARE]	7
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	ALAVERT ALLERGY (LORATADINE) TABLET, ORALLY DISINTEGRATING [PFIZER CONSUMER HEALTHCARE]	7
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	ALAVERT ALLERGY (LORATADINE) TABLET, ORALLY DISINTEGRATING [PFIZER CONSUMER HEALTHCARE]	7
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	ALAVERT ALLERGY (LORATADINE) TABLET, ORALLY DISINTEGRATING [PFIZER CONSUMER HEALTHCARE]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALAVERT ALLERGY (LORATADINE) TABLET, ORALLY DISINTEGRATING [PFIZER CONSUMER HEALTHCARE]	7
CORN SYRUP	INACTIVE INGREDIENT	9G5L16BK6N	ALAVERT ALLERGY (LORATADINE) TABLET, ORALLY DISINTEGRATING [PFIZER CONSUMER HEALTHCARE]	7
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ALAVERT ALLERGY (LORATADINE) TABLET, ORALLY DISINTEGRATING [PFIZER CONSUMER HEALTHCARE]	7
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ALAVERT ALLERGY (LORATADINE) TABLET, ORALLY DISINTEGRATING [PFIZER CONSUMER HEALTHCARE]	7
ICODEXTRIN	INACTIVE INGREDIENT	2NX48Z0A9G	ALAVERT ALLERGY (LORATADINE) TABLET, ORALLY DISINTEGRATING [PFIZER CONSUMER HEALTHCARE]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALAVERT ALLERGY (LORATADINE) TABLET, ORALLY DISINTEGRATING [PFIZER CONSUMER HEALTHCARE]	7
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	ALAVERT ALLERGY (LORATADINE) TABLET, ORALLY DISINTEGRATING [PFIZER CONSUMER HEALTHCARE]	7
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ALAVERT ALLERGY (LORATADINE) TABLET, ORALLY DISINTEGRATING [PFIZER CONSUMER HEALTHCARE]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ALAVERT ALLERGY (LORATADINE) TABLET, ORALLY DISINTEGRATING [PFIZER CONSUMER HEALTHCARE]	7
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	ALAVERT ALLERGY (LORATADINE) TABLET, ORALLY DISINTEGRATING [PFIZER CONSUMER HEALTHCARE]	7

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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0573-2620-71	00573262071	1500 POUCH in 1 BOX (0573-2620-71) > 1 TABLET, ORALLY DISINTEGRATING in 1 POUCH	1500 pouch	2002-12-19	0000-00-00	No	No	Current