Loratadine

Product NDC: 49035-953
11-digit product format: 490350953
Labeler code: 49035
Product ID: 49035-953_0ea6cbb4-1105-fecf-e063-6394a90a513b
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Wal-Mart Stores, Inc
Application: ANDA210088
Marketing category: ANDA
Marketing start: 2018-05-01
Substance: LORATADINE
Active strength: 5 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 49035-953_0ea6cbb4-1105-fecf-e063-6394a90a513b
SPL ID: 0ea6cbb4-1105-fecf-e063-6394a90a513b
Product type: HUMAN OTC DRUG
Finished product: Yes
Brand name base: Loratadine
Generic name: Loratadine
Dosage form: TABLET, CHEWABLE
Route: ORAL
Marketing start: 2018-05-01
Marketing category: ANDA
Application number: ANDA210088
Listing expiration: 2026-12-31

openFDA Active Ingredients

Ingredient	Strength
LORATADINE	5 mg/1

openFDA Harmonized Identifiers

Field	Values
Unii	7AJO3BO7QN
Rxcui	665078
Spl Set Id	f62c48ab-8dd3-4ed1-a123-d478efe8e839
Manufacturer Name	Wal-Mart Stores, Inc

openFDA Package Details

Package NDC	Description	Marketing start	Sample
49035-953-30	3 BLISTER PACK in 1 CARTON (49035-953-30) / 10 TABLET, CHEWABLE in 1 BLISTER PACK	2018-05-01	No

Related Records

Related UNII Ingredients

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

Packages

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
49035-953-30	49035095330	3 BLISTER PACK in 1 CARTON (49035-953-30) / 10 TABLET, CHEWABLE in 1 BLISTER PACK	3 blister pack	2018-05-01	No	No	Historical

Related DailyMed Labels

Title	Manufacturer	Effective date	Type	Version
Loratadine	Wal-Mart Stores, Inc \| Ohm Laboratories Inc.	2024-01-11	HUMAN OTC DRUG LABEL	3