FDA.reportPublic FDA data

Pseudoephedrine HCl

Product NDC
21130-158
11-digit product format
211300158
Labeler code
21130
Product ID
21130-158_14aa89a7-5eb1-4037-a169-cbb527b46e95
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine HCl
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Better Living Brands LLC
Application
ANDA209008
Marketing category
ANDA
Marketing start
2023-09-01
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
Pseudoephedrine HCl
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
21130-158-67Pseudoephedrine HCl10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE102
21130-158-67Pseudoephedrine HCl2 in 1 CARTONTABLET, EXTENDED RELEASE22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-158PSEUDOEPHEDRINE HCL TABLET, EXTENDED RELEASE [BETTER LIVING BRANDS LLC]2Current NDC, 2 package rows20240725_f9d5a22a-3964-08b8-e053-6294a90ab220.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049154pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSNf9d5a22a-3964-08b8-e053-6294a90ab2202
104915412 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCDf9d5a22a-3964-08b8-e053-6294a90ab2202
1049154pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSYf9d5a22a-3964-08b8-e053-6294a90ab2202

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21130-158-67211300158672 BLISTER PACK in 1 CARTON (21130-158-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2023-09-01NoNoCurrent