Home NDC 50066-396-09 Allergy Relief
Product NDC 50066-396
Requested package NDC 50066-396-09
11-digit product format 500660396
Labeler code 50066
Product ID 50066-396_d5a01d33-2431-447c-83d2-081ee63663a1
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine HCl 10 mg
Dosage form TABLET
Route ORAL
Labeler Genomma Labs USA, Inc
Application ANDA209274
Marketing category ANDA
Marketing start 2017-12-22
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2017-12-22
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 cb3db0bc1861…
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 3 · 56 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cetirizine hydrochloride - HIVES CETIRIZINE HYDROCHLORIDE Granules Pharmaceuticals Inc. 562b5e6c-6103-df3d-e063-6394a90a897d 2026-07-14 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 Cetirizine hydrochloride CETIRIZINE HYDROCHLORIDE Granules India Ltd 6efd5a60-e281-43f9-a52c-a95f46fbcbfc 2026-07-14 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 Medline CETIRIZINE HCL Medline Industries, LP a75cd557-e19b-fdd4-e053-2a95a90a8097 2026-06-04 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 Allergy Relief CETIRIZINE HYDROCHLORIDE AAA PHARMACEUTICAL, INC. ac22558b-5c82-4ab9-95b8-53eedea46282 2026-05-28 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 Allergy Relief CETIRIZINE HYDROCHLORIDE Grocery Outlet, Inc 441d049c-8844-955e-e063-6294a90a666d 2026-05-21 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE TWIN MED, LLC 14317ee7-1061-4c2b-9427-3433e27f13f5 2026-04-01 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 Allergy Relief CETIRIZINE HCL Bryant Ranch Prepack 7e4a2d02-c2b3-4a1f-8373-a0b0dec5ddea 2026-03-10 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 All Day Allergy Relief CETIRIZINE HCL P & L Development, LLC c5dab2f3-8f95-4b85-995b-23b21c762ae8 2026-02-23 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 All Day Allergy Relief CETIRIZINE HCL Strategic Sourcing Services LLC 2965303e-bedc-41fb-af97-827c30575091 2026-01-05 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE Granules USA, Inc. c8d711cd-7214-c7d5-e053-2995a90a6b67 2025-12-22 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE RETAIL BUSINESS SERVICES,LLC. 9f04520e-161d-3f7b-e053-2a95a90a678d 2025-12-19 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 Cetirizine HCL CETIRIZINE HCL Meijer 181c63dd-6ab8-909a-e063-6394a90af141 2025-12-19 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 Cetirizine CETIIRIZINE CVS PHARMACY, INC fd8f495a-9940-363b-e053-6294a90a1097 2025-12-19 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE SAFEWAY ed0eecfb-85bf-63bf-e053-2995a90a0e03 2025-12-18 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 Allergy Relief CETIRIZINE HYDROCHLORIDE VALU MERCHANDISERS COMPANY dc66bf53-820f-40a3-b5ef-c653dd375544 2025-12-11 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 Cetirizine hydrochloride CETIRIZINE HYDROCHLORIDE Granules Pharmaceuticals Inc. d55dfce1-acef-3342-e053-2a95a90a4b83 2025-12-04 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 CAREALL Allergy Relief CETIRIZINE HCL New World Imports d3411eec-05b1-49b3-86e8-bc47ac0ef6b7 2025-12-01 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 Allergy Relief CETIRIZINE HCL Family Dollar (FAMILY WELLNESS) b90b5ef2-5aa2-45ca-94b9-c9d9e5877e23 2025-09-25 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 Wal-Zyr CETIRIZINE HCL Walgreens f0d3f681-92c4-45d4-9533-656c9e5e2366 2025-07-02 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 Cetirizine hydrochloride CETIRIZINE HYDROCHLORIDE Advanced Rx LLC 737492bf-96bd-4f7c-aa42-4910746f44bb 2025-05-13 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50066-396-09 50066039609 1 BLISTER PACK in 1 CARTON (50066-396-09) > 10 TABLET in 1 BLISTER PACK 1 blister pack 2019-09-20 0000-00-00 No No Current