Levocetirizine Dihydrochloride

Product NDC
31722-551
Requested package NDC
31722-551-18
11-digit product format
317220551
Labeler code
31722
Product ID
31722-551_40ccc1d7-149b-e682-e063-6394a90a1d37
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levocetirizine Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA091264
Marketing category
ANDA
Marketing start
2012-06-29
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
A091264-001LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091264-001AB

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 UTC2026-02A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-293f01610625f2…
2019-09-15 20:21 UTC2019-09A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091264-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2012-06-29cb3db0bc1861…

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 UTC2026-02A091264-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091264-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091264-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091264-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091264-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091264-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091264-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091264-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091264-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091264-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091264-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091264-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091264-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091264-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091264-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091264-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091264-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091264-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091264-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091264-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091264-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A091264-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091264-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091264-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091264-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A091264-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091264-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091264-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091264-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091264-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091264-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091264-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091264-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091264-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A091264-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A091264-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091264-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091264-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091264-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091264-001AB1cb3db0bc1861…

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
dd407f8f-140d-489f-b8c5-f6602d87e247Available 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
31722-551-05Levocetirizine Dihydrochloride500 in 1 BOTTLETABLET5008
31722-551-10Levocetirizine Dihydrochloride1000 in 1 BOTTLETABLET10008
31722-551-18Levocetirizine Dihydrochloride180 in 1 BOTTLETABLET1808
31722-551-30Levocetirizine Dihydrochloride30 in 1 BOTTLETABLET308
31722-551-90Levocetirizine Dihydrochloride90 in 1 BOTTLETABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-551-90EA - Each31722-55188e601dd-f70d-4158-a7b2-cc0c53e6a27012013-02-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-551LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 5 package rows20250110_dd407f8f-140d-489f-b8c5-f6602d87e247.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEA-S Medication Solutionsd8b4b326-8be1-4404-9db7-636d869331392026-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091264
application number: ANDA091264
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDENorthwind Health Company, LLCf2b458d6-ac10-0fed-e053-2a95a90a0f9c2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091264
application number: ANDA091264
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDECamber Pharmaceuticals, Inc.dd407f8f-140d-489f-b8c5-f6602d87e2472025-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091264
application number: ANDA091264
ndc (package): 31722-551-18
ndc (product): 31722-551
ndc11 (package): 31722055118
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEBryant Ranch Prepackb7bbffcb-5f56-4735-998a-eadd07dfa2cb2025-09-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091264
application number: ANDA091264
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.57c7c673-790c-4158-87ca-7d8fb68c42862025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091264
application number: ANDA091264
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEA-S Medication Solutions7c163007-7e0d-4d55-8ae1-89defe55580f2023-12-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091264
application number: ANDA091264

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSNd8b4b326-8be1-4404-9db7-636d8693313915
855172levocetirizine dihydrochloride 5 MG Oral TabletSCDd8b4b326-8be1-4404-9db7-636d8693313915
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSYd8b4b326-8be1-4404-9db7-636d8693313915
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN57c7c673-790c-4158-87ca-7d8fb68c428613
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD57c7c673-790c-4158-87ca-7d8fb68c428613
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY57c7c673-790c-4158-87ca-7d8fb68c428613
855172levocetirizine dihydrochloride 5 MG Oral TabletPSNdd407f8f-140d-489f-b8c5-f6602d87e2478
855172levocetirizine dihydrochloride 5 MG Oral TabletSCDdd407f8f-140d-489f-b8c5-f6602d87e2478
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSYdd407f8f-140d-489f-b8c5-f6602d87e2478
855172levocetirizine dihydrochloride 5 MG Oral TabletPSNb7bbffcb-5f56-4735-998a-eadd07dfa2cb6
855172levocetirizine dihydrochloride 5 MG Oral TabletSCDb7bbffcb-5f56-4735-998a-eadd07dfa2cb6
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSYb7bbffcb-5f56-4735-998a-eadd07dfa2cb6
855172levocetirizine dihydrochloride 5 MG Oral TabletPSNf2b458d6-ac10-0fed-e053-2a95a90a0f9c3
855172levocetirizine dihydrochloride 5 MG Oral TabletSCDf2b458d6-ac10-0fed-e053-2a95a90a0f9c3
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSYf2b458d6-ac10-0fed-e053-2a95a90a0f9c3
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN7c163007-7e0d-4d55-8ae1-89defe55580f1
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD7c163007-7e0d-4d55-8ae1-89defe55580f1
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY7c163007-7e0d-4d55-8ae1-89defe55580f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-551-1831722055118180 TABLET in 1 BOTTLE (31722-551-18) 180 tablet2012-06-290000-00-00NoNoCurrent