FDA.reportPublic FDA data

Cetirizine Hydrochloride

Product NDC
16571-402
11-digit product format
165710402
Labeler code
16571
Product ID
16571-402_538948d8-34aa-4460-8d66-ee8fcf4c60ab
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA077829
Marketing category
ANDA
Marketing start
2009-10-01
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 Hydrochloride
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
16571-402-10Cetirizine Hydrochloride100 in 1 BOTTLETABLET10013
16571-402-30Cetirizine Hydrochloride300 in 1 BOTTLETABLET30013
16571-402-50Cetirizine Hydrochloride500 in 1 BOTTLETABLET50013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-402-10EA - Each16571-4022524d8a5-6929-4792-b28d-276f9c97b20e12012-07-24
16571-402-50EA - Each16571-402a6cd2ed0-855f-460d-a2cb-5f7054e8e84912013-02-13
16571-402-90EA - Each16571-402d8ef7ec6-0a15-4216-95b1-e5296fd2d24212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Cetirizine HydrochlorideACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE TABLET [PACK PHARMACEUTICALS LLC]7
CetirizineACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE TABLET [PACK PHARMACEUTICALS LLC]7
hypromellosesINACTIVE INGREDIENT3NXW29V3WOCETIRIZINE HYDROCHLORIDE TABLET [PACK PHARMACEUTICALS LLC]7
lactoseINACTIVE INGREDIENTJ2B2A4N98GCETIRIZINE HYDROCHLORIDE TABLET [PACK PHARMACEUTICALS LLC]7
magnesium stearateINACTIVE INGREDIENT70097M6I30CETIRIZINE HYDROCHLORIDE TABLET [PACK PHARMACEUTICALS LLC]7
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1ACETIRIZINE HYDROCHLORIDE TABLET [PACK PHARMACEUTICALS LLC]7
povidoneINACTIVE INGREDIENTFZ989GH94ECETIRIZINE HYDROCHLORIDE TABLET [PACK PHARMACEUTICALS LLC]7
starch, cornINACTIVE INGREDIENTO8232NY3SJCETIRIZINE HYDROCHLORIDE TABLET [PACK PHARMACEUTICALS LLC]7
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCETIRIZINE HYDROCHLORIDE TABLET [PACK PHARMACEUTICALS LLC]7
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE TABLET [DIRECT RX]4
CETIRIZINEACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE TABLET [DIRECT RX]4
hypromellosesINACTIVE INGREDIENT3NXW29V3WOCETIRIZINE HYDROCHLORIDE TABLET [DIRECT RX]4
lactoseINACTIVE INGREDIENTJ2B2A4N98GCETIRIZINE HYDROCHLORIDE TABLET [DIRECT RX]4
magnesium stearateINACTIVE INGREDIENT70097M6I30CETIRIZINE HYDROCHLORIDE TABLET [DIRECT RX]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACETIRIZINE HYDROCHLORIDE TABLET [DIRECT RX]4
povidoneINACTIVE INGREDIENTFZ989GH94ECETIRIZINE HYDROCHLORIDE TABLET [DIRECT RX]4
starch, cornINACTIVE INGREDIENTO8232NY3SJCETIRIZINE HYDROCHLORIDE TABLET [DIRECT RX]4
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCETIRIZINE HYDROCHLORIDE TABLET [DIRECT RX]4
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
CETIRIZINEACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCETIRIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GCETIRIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CETIRIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACETIRIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ECETIRIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCETIRIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCETIRIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
Cetirizine HydrochlorideACTIVE INGREDIENT64O047KTOACETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CETIRIZINEACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CetirizineACTIVE MOIETYYO7261ME24CETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCETIRIZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GCETIRIZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GCETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CETIRIZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACETIRIZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ECETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ECETIRIZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCETIRIZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCETIRIZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-402CETIRIZINE HYDROCHLORIDE TABLET [RISING PHARMA HOLDINGS, INC.]12Current NDC, Legacy NDC, 3 package rows20240319_5481ccb3-b311-4b25-b923-4fe8522ea92b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN5481ccb3-b311-4b25-b923-4fe8522ea92b13
1014678cetirizine hydrochloride 10 MG Oral TabletSCD5481ccb3-b311-4b25-b923-4fe8522ea92b13
1014678cetirizine HCl 10 MG Oral TabletSY5481ccb3-b311-4b25-b923-4fe8522ea92b13
1014678cetirizine HCl 10 MG Oral TabletPSN4b192084-dfdc-47bc-a968-6f49e137b2489
1014678cetirizine hydrochloride 10 MG Oral TabletSCD4b192084-dfdc-47bc-a968-6f49e137b2489
1014678cetirizine HCl 10 MG Oral TabletSY4b192084-dfdc-47bc-a968-6f49e137b2489
1014678cetirizine HCl 10 MG Oral TabletPSNb7a580d5-edfc-41b5-9713-ea18eeb9252e8
1014678cetirizine hydrochloride 10 MG Oral TabletSCDb7a580d5-edfc-41b5-9713-ea18eeb9252e8
1014678cetirizine HCl 10 MG Oral TabletSYb7a580d5-edfc-41b5-9713-ea18eeb9252e8
1014678cetirizine HCl 10 MG Oral TabletPSN4913192a-7364-3f19-e054-00144ff8d46c5
1014678cetirizine hydrochloride 10 MG Oral TabletSCD4913192a-7364-3f19-e054-00144ff8d46c5
1014678cetirizine HCl 10 MG Oral TabletSY4913192a-7364-3f19-e054-00144ff8d46c5
1014678cetirizine HCl 10 MG Oral TabletPSN3a58cd65-a4ab-4aa9-a6a0-0860019642ce4
1014678cetirizine hydrochloride 10 MG Oral TabletSCD3a58cd65-a4ab-4aa9-a6a0-0860019642ce4
1014678cetirizine HCl 10 MG Oral TabletSY3a58cd65-a4ab-4aa9-a6a0-0860019642ce4
1014678cetirizine HCl 10 MG Oral TabletPSNafd7b4c9-9ef0-52e8-e053-2a95a90a6b333
1014678cetirizine HCl 10 MG Oral TabletPSN4445548f-d11c-3c1b-e054-00144ff8d46c3
1014678cetirizine hydrochloride 10 MG Oral TabletSCD4445548f-d11c-3c1b-e054-00144ff8d46c3
1014678cetirizine hydrochloride 10 MG Oral TabletSCDafd7b4c9-9ef0-52e8-e053-2a95a90a6b333
1014678cetirizine HCl 10 MG Oral TabletSY4445548f-d11c-3c1b-e054-00144ff8d46c3
1014678cetirizine HCl 10 MG Oral TabletSYafd7b4c9-9ef0-52e8-e053-2a95a90a6b333
1014678cetirizine HCl 10 MG Oral TabletPSN0b116de8-55c5-44dc-b0b6-f5a919e39a652
1014678cetirizine HCl 10 MG Oral TabletPSNf2f42f36-6b09-4140-e053-2a95a90af8132
1014678cetirizine HCl 10 MG Oral TabletPSN147e91e6-0840-05ee-e054-00144ff8d46c2
1014678cetirizine hydrochloride 10 MG Oral TabletSCD147e91e6-0840-05ee-e054-00144ff8d46c2
1014678cetirizine hydrochloride 10 MG Oral TabletSCDf2f42f36-6b09-4140-e053-2a95a90af8132
1014678cetirizine hydrochloride 10 MG Oral TabletSCD0b116de8-55c5-44dc-b0b6-f5a919e39a652
1014678cetirizine HCl 10 MG Oral TabletSY147e91e6-0840-05ee-e054-00144ff8d46c2
1014678cetirizine HCl 10 MG Oral TabletSY0b116de8-55c5-44dc-b0b6-f5a919e39a652
1014678cetirizine HCl 10 MG Oral TabletSYf2f42f36-6b09-4140-e053-2a95a90af8132
1014678cetirizine HCl 10 MG Oral TabletPSN3d3596d8-cebc-4bdf-be21-3f5a4e0446ad1
1014678cetirizine HCl 10 MG Oral TabletPSNdd50d2e9-3de7-4c44-96ed-39ef04dae7021
1014678cetirizine HCl 10 MG Oral TabletPSNdf5f520a-9d1f-4b56-971c-cfb46416750f1
1014678cetirizine hydrochloride 10 MG Oral TabletSCD3d3596d8-cebc-4bdf-be21-3f5a4e0446ad1
1014678cetirizine hydrochloride 10 MG Oral TabletSCDdd50d2e9-3de7-4c44-96ed-39ef04dae7021
1014678cetirizine hydrochloride 10 MG Oral TabletSCDdf5f520a-9d1f-4b56-971c-cfb46416750f1
1014678cetirizine HCl 10 MG Oral TabletSY3d3596d8-cebc-4bdf-be21-3f5a4e0446ad1
1014678cetirizine HCl 10 MG Oral TabletSYdd50d2e9-3de7-4c44-96ed-39ef04dae7021
1014678cetirizine HCl 10 MG Oral TabletSYdf5f520a-9d1f-4b56-971c-cfb46416750f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-402-1016571040210100 TABLET in 1 BOTTLE (16571-402-10) 100 tablet2009-10-010000-00-00NoNoCurrent
16571-402-3016571040230300 TABLET in 1 BOTTLE (16571-402-30) 300 tablet2026-05-10NoNoCurrent
16571-402-5016571040250500 TABLET in 1 BOTTLE (16571-402-50) 500 tablet2009-10-010000-00-00NoNoCurrent