Loratadine 10 mg

Product NDC: 49483-732
Requested package NDC: 49483-732-65
11-digit product format: 494830732
Labeler code: 49483
Product ID: 49483-732_2c80ea14-8491-4d26-e063-6294a90aecf0
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine Tablets USP, 10 mg
Dosage form: TABLET
Route: ORAL
Labeler: TIME CAP LABORATORIES, INC.
Application: ANDA219223
Marketing category: ANDA
Marketing start: 2025-01-25
Substance: LORATADINE
Active strength: 10 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
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
A219223-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2024-11-21

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	A219223-001	LORATADINE	10MG	TABLET / ORAL	2024-11-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219223-001	LORATADINE	10MG	TABLET / ORAL	2024-11-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219223-001	LORATADINE	10MG	TABLET / ORAL	2024-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219223-001	LORATADINE	10MG	TABLET / ORAL	2024-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219223-001	LORATADINE	10MG	TABLET / ORAL	2024-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A219223-001	LORATADINE	10MG	TABLET / ORAL	2024-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A219223-001	LORATADINE	10MG	TABLET / ORAL	2024-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A219223-001	LORATADINE	10MG	TABLET / ORAL	2024-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A219223-001	LORATADINE	10MG	TABLET / ORAL	2024-11-21	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219223-001	LORATADINE	10MG	TABLET / ORAL	2024-11-21	`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 10 mg
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
2c80ea14-8490-4d26-e063-6294a90aecf0	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49483-732-65	Loratadine 10 mg	365 in 1 BOTTLE	TABLET	365		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49483-732	LORATADINE 10 MG (LORATADINE TABLETS USP, 10 MG) TABLET [TIME CAP LABORATORIES, INC.]	1	Current NDC, 1 package rows	20250126_2c80ea14-8490-4d26-e063-6294a90aecf0.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
Loratadine 10 mg	LORATADINE TABLETS USP, 10 MG	TIME CAP LABORATORIES, INC.	2c80ea14-8490-4d26-e063-6294a90aecf0	2025-01-24	Warnings	Exact identifier application applno (ANDA): 219223 application number: ANDA219223 ndc (package): 49483-732-65 ndc (product): 49483-732 ndc11 (package): 49483073265
Loratadine 10mg	LORATADINE 10MG	MARKSANS PHARMA LIMITED	3360d02d-612d-4cc5-acc9-2cc93713c387	2024-11-25	Warnings	Exact identifier application applno (ANDA): 219223 application number: ANDA219223

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	2c80ea14-8490-4d26-e063-6294a90aecf0	1
311372	loratadine 10 MG Oral Tablet	SCD	2c80ea14-8490-4d26-e063-6294a90aecf0	1
311372	loratadine 10 MG 24 HR Oral Tablet	SY	2c80ea14-8490-4d26-e063-6294a90aecf0	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
49483-732-65	49483073265	365 TABLET in 1 BOTTLE (49483-732-65)	365 tablet	2025-01-25	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Timely Loratadine Tablets USP, 10 mg	TIME CAP LABORATORIES, INC. \| MARKSANS PHARMA LIMITED	2025-01-24	HUMAN OTC DRUG LABEL	1