Claritin-D

Product NDC
70518-3566
11-digit product format
705183566
Labeler code
70518
Product ID
70518-3566_ec6ba057-440a-6a55-e053-2a95a90a6434
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine and pseudoephedrine sulfate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA019670
Marketing category
NDA
Marketing start
2022-10-31
Marketing end
0000-00-00
Substance
LORATADINE; PSEUDOEPHEDRINE SULFATE
Active strength
5 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3566-02024-10-09C16284748780-11030e365-0995-111a-e063-dadaa90a10e2cb53b25e-a3a1-4fda-9528-1e48aae88487
70518-3566-02024-01-30C16284748780-11030e365-0995-111a-e063-dadaa90a10e2cb53b25e-a3a1-4fda-9528-1e48aae88487

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3566-0705183566002 BLISTER PACK in 1 CARTON (70518-3566-0) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2022-10-310000-00-00NoNoCurrent