FDA.reportPublic FDA data

Cetirizine

Product NDC
0904-6717
11-digit product format
009046717
Labeler code
0904
Product ID
0904-6717_cdf7d985-c5aa-4002-a152-58fe4d6ba6e2
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA078336
Marketing category
ANDA
Marketing start
2018-06-29
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014678

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6717-40Cetirizine500 in 1 BOTTLETABLET, FILM COATED5007
0904-6717-41Cetirizine14 in 1 CARTONTABLET, FILM COATED147
0904-6717-41Cetirizine1 in 1 BLISTER PACKTABLET, FILM COATED17
0904-6717-43Cetirizine1 in 1 CARTONTABLET, FILM COATED17
0904-6717-43Cetirizine45 in 1 BOTTLETABLET, FILM COATED457
0904-6717-46Cetirizine1 in 1 CARTONTABLET, FILM COATED17
0904-6717-46Cetirizine30 in 1 BOTTLETABLET, FILM COATED307
0904-6717-60Cetirizine1 in 1 CARTONTABLET, FILM COATED17
0904-6717-60Cetirizine100 in 1 BOTTLETABLET, FILM COATED1007
0904-6717-61Cetirizine1 in 1 BLISTER PACKTABLET, FILM COATED17
0904-6717-61Cetirizine100 in 1 CARTONTABLET, FILM COATED1007
0904-6717-72Cetirizine1 in 1 CARTONTABLET, FILM COATED17
0904-6717-72Cetirizine300 in 1 BOTTLETABLET, FILM COATED3007
0904-6717-86Cetirizine1 in 1 CARTONTABLET, FILM COATED17
0904-6717-86Cetirizine90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6717-40EA - Each0904-6717f836f917-68b4-4279-87a8-d943f56cc75a12018-12-13
0904-6717-41EA - Each0904-6717c1139d16-e6d6-4f31-8136-922a365b0aa112018-10-11
0904-6717-43EA - Each0904-6717805bfee7-85ef-492f-b7ab-6d25b297b36d12018-11-06
0904-6717-46EA - Each0904-671787d2394e-5cf4-4e9d-8900-7c4cae2ee1b012018-09-05
0904-6717-60EA - Each0904-67173c9dbd19-eac8-4b40-81c3-e8a130e44ac912018-11-06
0904-6717-61EA - Each0904-6717e0b678ec-2dfa-4447-bb22-932ab1cdc60612019-04-11
0904-6717-72EA - Each0904-6717e7132d35-445a-4f54-b0f7-037d318857b812018-08-13
0904-6717-86EA - Each0904-671797eabf80-1f19-46a2-91d2-51c85849f35812018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6717CETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5Current NDC, Legacy NDC, 15 package rows20250426_a5be7921-c1cb-4b9f-9f4a-1c4b68b2b8a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN7e158fd6-268d-4ffc-a410-d054090d54c5101
1014678cetirizine hydrochloride 10 MG Oral TabletSCD7e158fd6-268d-4ffc-a410-d054090d54c5101
1014678cetirizine HCl 10 MG Oral TabletSY7e158fd6-268d-4ffc-a410-d054090d54c5101
1014678cetirizine HCl 10 MG Oral TabletPSNff782956-03b7-4ae6-b78f-fb7fe78b262d11
1014678cetirizine hydrochloride 10 MG Oral TabletSCDff782956-03b7-4ae6-b78f-fb7fe78b262d11
1014678cetirizine HCl 10 MG Oral TabletSYff782956-03b7-4ae6-b78f-fb7fe78b262d11
1014678cetirizine HCl 10 MG Oral TabletPSN6f3c2e57-7a0f-432f-a7f1-04906f5e4ddf8
1014678cetirizine hydrochloride 10 MG Oral TabletSCD6f3c2e57-7a0f-432f-a7f1-04906f5e4ddf8
1014678cetirizine HCl 10 MG Oral TabletSY6f3c2e57-7a0f-432f-a7f1-04906f5e4ddf8
1014678cetirizine HCl 10 MG Oral TabletPSNa5be7921-c1cb-4b9f-9f4a-1c4b68b2b8a37
1014678cetirizine hydrochloride 10 MG Oral TabletSCDa5be7921-c1cb-4b9f-9f4a-1c4b68b2b8a37
1014678cetirizine HCl 10 MG Oral TabletSYa5be7921-c1cb-4b9f-9f4a-1c4b68b2b8a37
1014678cetirizine HCl 10 MG Oral TabletPSNf2b4d221-30ae-5a43-e053-2995a90a238a3
1014678cetirizine HCl 10 MG Oral TabletPSN71db132d-dca4-47ef-8560-c68ad22589333
1014678cetirizine HCl 10 MG Oral TabletPSN4a45672b-67d3-4739-86ec-0a6696dd83d43
1014678cetirizine hydrochloride 10 MG Oral TabletSCD4a45672b-67d3-4739-86ec-0a6696dd83d43
1014678cetirizine hydrochloride 10 MG Oral TabletSCDf2b4d221-30ae-5a43-e053-2995a90a238a3
1014678cetirizine hydrochloride 10 MG Oral TabletSCD71db132d-dca4-47ef-8560-c68ad22589333
1014678cetirizine HCl 10 MG Oral TabletSY4a45672b-67d3-4739-86ec-0a6696dd83d43
1014678cetirizine HCl 10 MG Oral TabletSY71db132d-dca4-47ef-8560-c68ad22589333
1014678cetirizine HCl 10 MG Oral TabletSYf2b4d221-30ae-5a43-e053-2995a90a238a3
1014678cetirizine HCl 10 MG Oral TabletPSN88c3d23e-a0d8-4464-9414-666d74f11f662
1014678cetirizine hydrochloride 10 MG Oral TabletSCD88c3d23e-a0d8-4464-9414-666d74f11f662
1014678cetirizine HCl 10 MG Oral TabletSY88c3d23e-a0d8-4464-9414-666d74f11f662
1014678cetirizine HCl 10 MG Oral TabletPSN43f40b92-f0e0-8808-e063-6394a90a656b1
1014678cetirizine hydrochloride 10 MG Oral TabletSCD43f40b92-f0e0-8808-e063-6394a90a656b1
1014678cetirizine HCl 10 MG Oral TabletSY43f40b92-f0e0-8808-e063-6394a90a656b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6717-4000904671740500 TABLET, FILM COATED in 1 BOTTLE (0904-6717-40) 2018-07-030000-00-00NoNoCurrent
0904-6717-410090467174114 BLISTER PACK in 1 CARTON (0904-6717-41) / 1 TABLET, FILM COATED in 1 BLISTER PACK14 blister pack2018-06-290000-00-00NoNoCurrent
0904-6717-43009046717431 BOTTLE in 1 CARTON (0904-6717-43) / 45 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-07-030000-00-00NoNoCurrent
0904-6717-46009046717461 BOTTLE in 1 CARTON (0904-6717-46) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-07-030000-00-00NoNoCurrent
0904-6717-60009046717601 BOTTLE in 1 CARTON (0904-6717-60) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-07-030000-00-00NoNoCurrent
0904-6717-6100904671761100 BLISTER PACK in 1 CARTON (0904-6717-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2018-06-292026-06-30NoNoCurrent
0904-6717-72009046717721 BOTTLE in 1 CARTON (0904-6717-72) / 300 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-07-030000-00-00NoNoCurrent
0904-6717-86009046717861 BOTTLE in 1 CARTON (0904-6717-86) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-07-030000-00-00NoNoCurrent