levocetirizine dihydrochloride

Product NDC
68788-7934
11-digit product format
687887934
Labeler code
68788
Product ID
68788-7934_4b5a138a-e5aa-4f49-a838-0e77480d4534
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levocetirizine dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA203646
Marketing category
ANDA
Marketing start
2021-06-15
Substance
LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203646-001LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A203646-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-093f01610625f2…
2019-09-15 20:21 UTC2019-09A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09b00525d2431f…
2019-07-19 19:46 UTC2019-07A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203646-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203646-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203646-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203646-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203646-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203646-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203646-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203646-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203646-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203646-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203646-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203646-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203646-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203646-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203646-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203646-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203646-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203646-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203646-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203646-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203646-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A203646-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203646-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203646-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203646-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A203646-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203646-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203646-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203646-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203646-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203646-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203646-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203646-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203646-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A203646-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A203646-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203646-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203646-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203646-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203646-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
levocetirizine dihydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOCETIRIZINE DIHYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOD6A38AGAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
855172Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8f308352-5854-409e-8bf7-bc9958cc3c5eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
36cf9111-9cc4-8f59-a74c-0c1cfbd4a760Product name720190702

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7934-1levocetirizine dihydrochloride100 in 1 BOTTLETABLET1005
68788-7934-3levocetirizine dihydrochloride30 in 1 BOTTLETABLET305
68788-7934-6levocetirizine dihydrochloride60 in 1 BOTTLETABLET605
68788-7934-9levocetirizine dihydrochloride90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7934-1EA - Each68788-79345dab8892-2417-4aa2-8169-a03b5f74d1a212021-07-15
68788-7934-3EA - Each68788-7934295d9c12-7f40-4331-8538-93d43c7d503712021-07-15
68788-7934-6EA - Each68788-7934a3eea648-d78b-4bdd-b8c4-ed398df5271e12021-07-15
68788-7934-9EA - Each68788-7934dbaecdd8-5c9c-465a-906d-6f2b657d450112021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7934LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 4 package rows20240614_8f308352-5854-409e-8bf7-bc9958cc3c5e.zip

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 1 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEBryant Ranch Prepack8274ca80-e7d3-4f4f-9901-cc5c589b4fef2026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203646
application number: ANDA203646
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEBryant Ranch Prepackbe58ca52-ab5d-4656-bfe0-bd57662359682026-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203646
application number: ANDA203646
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEBryant Ranch Prepackc79d3668-5243-4627-ad2b-cc7c045df1202026-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203646
application number: ANDA203646
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDENuCare Pharmaceuticals,Inc.c2dbf151-5b3d-5dfb-e053-2995a90a4c192026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203646
application number: ANDA203646
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDENorthwind Health Company, LLCdae403cd-b6fc-7c50-e053-2995a90a95e32026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203646
application number: ANDA203646
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEGolden State Medical Supply, Inc.163dcce7-4535-a596-e063-6394a90a634f2025-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203646
application number: ANDA203646
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEScieGen Pharmaceuticals, Inc.bd7fe481-dfe7-4dfd-aa05-6e2318a9234e2025-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203646
application number: ANDA203646
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEWestminster Pharmaceuticals, LLC85dcd6c0-7fb2-40b3-b07f-93bab169011d2025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203646
application number: ANDA203646
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEPreferred Pharmaceuticals, Inc.8f308352-5854-409e-8bf7-bc9958cc3c5e2025-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203646
application number: ANDA203646
ndc (product): 68788-7934
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs51d88b2a-d10d-4e7a-b874-98de480692232025-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203646
application number: ANDA203646
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEBryant Ranch Prepack4d0a0f8e-b298-46d2-b27d-0bb737507fed2024-04-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203646
application number: ANDA203646
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEProficient Rx LP7108ad0a-af1e-4172-b4ba-e5d9aaadfba72022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203646
application number: ANDA203646
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEProficient Rx LP1ceff0e6-1e66-4494-b986-1bd23eb6813e2022-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203646
application number: ANDA203646
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEProficient Rx LPb84ccb27-9c52-43b9-9a46-8f52a571045e2019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203646
application number: ANDA203646
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEBryant Ranch Prepack34541530-ae3b-4247-b08c-cd1c13e2e6a12019-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203646
application number: ANDA203646
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEVensun Pharmaceuticals, Inc.7a2ca8aa-ba0b-45b4-bdb3-6518793501302018-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203646
application number: ANDA203646

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN8f308352-5854-409e-8bf7-bc9958cc3c5e5
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD8f308352-5854-409e-8bf7-bc9958cc3c5e5
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY8f308352-5854-409e-8bf7-bc9958cc3c5e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7934-168788793401100 TABLET in 1 BOTTLE (68788-7934-1) 100 tablet2021-06-150000-00-00NoNoCurrent
68788-7934-36878879340330 TABLET in 1 BOTTLE (68788-7934-3) 30 tablet2021-06-150000-00-00NoNoCurrent
68788-7934-66878879340660 TABLET in 1 BOTTLE (68788-7934-6) 60 tablet2021-06-150000-00-00NoNoCurrent
68788-7934-96878879340990 TABLET in 1 BOTTLE (68788-7934-9) 90 tablet2021-06-150000-00-00NoNoCurrent