Pseudoephedrine hydrochloride

Product NDC
51660-204
11-digit product format
516600204
Labeler code
51660
Product ID
51660-204_59b6d775-716c-41f4-b0e4-48324205671a
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ohm Laboratories Inc.
Application
ANDA077442
Marketing category
ANDA
Marketing start
2006-04-28
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 hydrochloride
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
51660-204-21Pseudoephedrine hydrochloride20 in 1 BLISTER PACKTABLET, FILM COATED203
51660-204-69Pseudoephedrine hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51660-204-21EA - Each51660-20498106195-64e4-4273-8e1e-f2601462566112019-01-24
51660-204-69EA - Each51660-204ff886321-62de-47db-971f-ecae164ed05d12017-08-11

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51660-204PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED [OHM LABORATORIES INC.]3Current NDC, Legacy NDC, 2 package rows20240120_4e98dd9f-4ab9-4d95-95b0-799ce217da70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049154pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN0a2672f0-4e6f-48c9-8571-2d09f06253d75
104915412 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD0a2672f0-4e6f-48c9-8571-2d09f06253d75
1049154pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSY0a2672f0-4e6f-48c9-8571-2d09f06253d75
1049154pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN4e98dd9f-4ab9-4d95-95b0-799ce217da703
104915412 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD4e98dd9f-4ab9-4d95-95b0-799ce217da703
1049154pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSY4e98dd9f-4ab9-4d95-95b0-799ce217da703
1049154pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN3b5c81b7-7464-129f-e063-6294a90a48c02
104915412 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD3b5c81b7-7464-129f-e063-6294a90a48c02
1049154pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSY3b5c81b7-7464-129f-e063-6294a90a48c02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51660-204-215166002042120 TABLET, FILM COATED in 1 BLISTER PACK (51660-204-21) 2006-04-280000-00-00NoNoCurrent
51660-204-695166002046910 TABLET, FILM COATED in 1 BLISTER PACK (51660-204-69) 2006-04-280000-00-00NoNoCurrent