FDA.reportPublic FDA data

Pseudoephedrine hydrochloride

Product NDC
70677-1019
11-digit product format
706771019
Labeler code
70677
Product ID
70677-1019_512ccc87-b95a-7e0e-e063-6294a90a2716
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
STRATEGIC SOURCING SERVICES LLC
Application
ANDA077442
Marketing category
ANDA
Marketing start
2023-08-10
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pseudoephedrine hydrochloride
Listing expiration
2027-12-31

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
70677-1019-1Pseudoephedrine hydrochloride1 in 1 CARTONTABLET, FILM COATED12
70677-1019-1Pseudoephedrine hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED102
70677-1019-2Pseudoephedrine hydrochloride2 in 1 CARTONTABLET, FILM COATED22
70677-1019-2Pseudoephedrine hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1019-1EA - Each70677-10199c16ed02-80c3-41d8-b7ff-be3f73400bfd12024-01-04
70677-1019-2EA - Each70677-1019771a37df-376d-47e5-9d8c-bf2b52730d3712026-05-22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1019PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED [STRATEGIC SOURCING SERVICES LLC]1Current NDC, 4 package rows20230815_3bf95c58-4fd9-4caa-a54f-2e61a5eacae8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049154pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN3bf95c58-4fd9-4caa-a54f-2e61a5eacae82
104915412 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD3bf95c58-4fd9-4caa-a54f-2e61a5eacae82
1049154pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSY3bf95c58-4fd9-4caa-a54f-2e61a5eacae82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1019-1706771019011 BLISTER PACK in 1 CARTON (70677-1019-1) / 10 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2023-08-10NoNoHistorical
70677-1019-2706771019022 BLISTER PACK in 1 CARTON (70677-1019-2) / 10 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2026-05-06NoNoHistorical