FDA.reportPublic FDA data

Nasal Decongestant D

Product NDC
0363-3301
11-digit product format
003633301
Labeler code
0363
Product ID
0363-3301_0c060566-54b0-4fd9-9040-a7cc8917909d
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Walgreen Company
Application
ANDA075153
Marketing category
ANDA
Marketing start
2022-04-06
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
Nasal Decongestant D
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6V9V2RYJ8N
Rxcui1049154

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-3301-52Nasal Decongestant D10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE102
0363-3301-52Nasal Decongestant D1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE12
0363-3301-60Nasal Decongestant D1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE12
0363-3301-60Nasal Decongestant D20 in 1 CARTONTABLET, FILM COATED, EXTENDED RE202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-3301-52EA - Each0363-330123610885-cb3f-44be-bba2-75c1d53fd9c912024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-3301NASAL DECONGESTANT D (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WALGREEN COMPANY]2Current NDC, Legacy NDC, 4 package rows20221021_9572b6c9-172b-459e-82d1-7f92f0eaec8e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049154pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN9572b6c9-172b-459e-82d1-7f92f0eaec8e2
104915412 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD9572b6c9-172b-459e-82d1-7f92f0eaec8e2
1049154pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSY9572b6c9-172b-459e-82d1-7f92f0eaec8e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-3301-520036333015210 BLISTER PACK in 1 CARTON (0363-3301-52) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2022-04-060000-00-00NoNoCurrent
0363-3301-600036333016020 BLISTER PACK in 1 CARTON (0363-3301-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK20 blister pack2022-04-060000-00-00NoNoCurrent