Allergy

Product NDC: 63654-309
11-digit product format: 636540309
Labeler code: 63654
Product ID: 63654-309_39201d37-e750-420b-8035-feb97bc77c21
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: TABLET
Route: ORAL
Labeler: Selder, S.A. de C.V.
Application: ANDA076471
Marketing category: ANDA
Marketing start: 2014-12-16
Substance: LORATADINE
Active strength: 10 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product	63654-309		I	Inactivated by FDA		excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63654-309	63654-309-10	I	Inactivated by FDA		excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`

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
A076471-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2006-02-14

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	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Allergy
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
afdb0117-dd2d-4ab1-a2f4-2a88b6bf5251	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63654-309-10	2020-06-16	C162847	48780-1	9d75b9d0-43de-f424-e053-dadaa90a57ce	309 - XL-3 Allergy
63654-309-10	2020-01-31	C162847	48780-1	9d75b9d0-43de-f424-e053-dadaa90a57ce	309 - XL-3 Allergy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63654-309-10	Allergy	1 in 1 CARTON	TABLET	1		4
63654-309-10	Allergy	10 in 1 BLISTER PACK	TABLET	10		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63654-309	ALLERGY (LORATADINE) TABLET [SELDER, S.A. DE C.V.]	4	Current NDC, Legacy NDC, 2 package rows	20200617_afdb0117-dd2d-4ab1-a2f4-2a88b6bf5251.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loratadine	LORATADINE	Apotex Corp.	679164cc-7505-7ed4-13fe-87f06cb777d8	2025-09-22	Warnings	Exact identifier application applno (ANDA): 076471 application number: ANDA076471
Non-Drowsy Allergy Relief	LORATADINE TABLET	Lil' Drug Store Products, Inc.	031fc3e5-b5eb-447c-e063-6294a90a13b5	2023-08-17	Warnings	Exact identifier application applno (ANDA): 076471 application number: ANDA076471
Allergy Relief	LORATADINE	Allegiant Health	0991388a-2eb8-4913-9efc-adf411eddf3a	2018-11-08	Warnings	Exact identifier application applno (ANDA): 076471 application number: ANDA076471
Allergy	LORATADINE	Selder, S.A. de C.V.	afdb0117-dd2d-4ab1-a2f4-2a88b6bf5251	2016-12-22	Warnings	Exact identifier application applno (ANDA): 076471 application number: ANDA076471 ndc (product): 63654-309

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	afdb0117-dd2d-4ab1-a2f4-2a88b6bf5251	4
311372	loratadine 10 MG Oral Tablet	SCD	afdb0117-dd2d-4ab1-a2f4-2a88b6bf5251	4
311372	loratadine 10 MG 24 HR Oral Tablet	SY	afdb0117-dd2d-4ab1-a2f4-2a88b6bf5251	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63654-309-10	63654030910	1 BLISTER PACK in 1 CARTON (63654-309-10) / 10 TABLET in 1 BLISTER PACK	1 blister pack	2014-12-16	0000-00-00	No	No	Current