12 Hour Nasal Decongestant

Product NDC
59779-703
11-digit product format
597790703
Labeler code
59779
Product ID
59779-703_dcfaf9dd-eada-4fd1-84f0-ef0bc2dc5029
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA075153
Marketing category
ANDA
Marketing start
1999-12-01
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
120 mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
12 Hour Nasal Decongestant
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6V9V2RYJ8N
Rxcui1049154

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-703-525977907035210 BLISTER PACK in 1 CARTON (59779-703-52) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack1999-12-010000-00-00NoNoCurrent
59779-703-605977907036020 BLISTER PACK in 1 CARTON (59779-703-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK20 blister pack2000-09-110000-00-00NoNoCurrent