FDA.reportPublic FDA data

NDC 71335-3168-02 - cevimeline hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
71335-3168
Requested NDC
71335-3168-02
Package NDCs from labels
71335-3168-1, 71335-3168-2, 71335-3168-3, 71335-3168-02
Manufacturer
Bryant Ranch Prepack
Effective date
2026-08-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
cevimeline hydrochloride - Bryant Ranch PrepackBryant Ranch Prepack2026-08-04HUMAN PRESCRIPTION DRUG LABEL

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 ยท 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CEVIMELINE HYDROCHLORIDECEVIMELINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.2b429ea7-1c7c-47a4-803c-2546736f5c362026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 309140
unii: P81Q6V85NP
cevimeline hydrochlorideCEVIMELINE HYDROCHLORIDEBryant Ranch Prepack7fa69ad5-7fa7-4078-9328-aacbb0d145a42026-08-04Warnings, Adverse reactionsExact identifier
application number: NDA020989
ndc (package): 71335-3168-2
ndc (package): 71335-3168-3
ndc (package): 71335-3168-1
ndc (product): 71335-3168
ndc11 (package): 71335316802
rxcui: 309140
spl id: 0e5763b8-0263-43fa-beaa-7828aa1d5be4
spl set id: 7fa69ad5-7fa7-4078-9328-aacbb0d145a4
unii: P81Q6V85NP
Cevimeline HydrochlorideCEVIMELINE HYDROCHLORIDEASCLEMED USA INC.bcaaec18-4ee1-4cfd-84da-8fe3b8c54fc42026-05-18Warnings, Adverse reactionsExact identifier
rxcui: 309140
unii: P81Q6V85NP
CEVIMELINE HYDROCHLORIDECEVIMELINE HYDROCHLORIDEBryant Ranch Prepack75ae16d6-8822-4581-b747-ae894a45cdea2026-05-15Warnings, Adverse reactionsExact identifier
rxcui: 309140
unii: P81Q6V85NP
Cevimeline HydrochlorideCEVIMELINE HYDROCHLORIDEZydus Lifesciences Limited1a29e9ab-edb0-4ae8-8f20-f43d122d2b432026-03-16Exact identifier
rxcui: 309140
unii: P81Q6V85NP
Cevimeline HydrochlorideCEVIMELINE HYDROCHLORIDEMacleods Pharmaceuticals Limited990887c1-11ce-4a73-83b4-0ffc5a900c852026-01-31Warnings, Adverse reactionsExact identifier
rxcui: 309140
unii: P81Q6V85NP
CEVIMELINE HYDROCHLORIDECEVIMELINE HYDROCHLORIDEAdvagen Pharma Ltd61dd5ee1-cf89-43ea-ada4-4e4a4d9d133b2025-12-31Warnings, Adverse reactionsExact identifier
rxcui: 309140
unii: P81Q6V85NP
Cevimeline HydrochlorideCEVIMELINE HYDROCHLORIDEBryant Ranch Prepack71ada1b0-3344-4202-9277-57f1a37402c12025-11-04Warnings, Adverse reactionsExact identifier
rxcui: 309140
unii: P81Q6V85NP
Cevimeline HydrochlorideCEVIMELINE HYDROCHLORIDEViona Pharmaceuticals Incca0409bc-2685-4ffd-b806-04898902a5972025-07-14Warnings, Adverse reactionsExact identifier
rxcui: 309140
unii: P81Q6V85NP
Cevimeline HydrochlorideCEVIMELINE HYDROCHLORIDEBryant Ranch Prepackfe30c870-a060-4a5b-ae61-6a99338544192024-10-08Warnings, Adverse reactionsExact identifier
rxcui: 309140
unii: P81Q6V85NP
Cevimeline HydrochlorideCEVIMELINE HYDROCHLORIDEBryant Ranch Prepack51307f82-66f2-41c7-80ff-174d7e50f7ee2024-09-05Warnings, Adverse reactionsExact identifier
rxcui: 309140
unii: P81Q6V85NP
Cevimeline HydrochlorideCEVIMELINE HYDROCHLORIDERising Pharma Holdings, Inc.d4bd942a-1339-40c5-8fd4-850da5a696352024-08-02Warnings, Adverse reactionsExact identifier
rxcui: 309140
unii: P81Q6V85NP
CEVIMELINECEVIMELINE HYDROCHLORIDEBionpharma Inc0f15cb50-5917-c928-e063-6294a90ab2842024-02-08Warnings, Adverse reactionsExact identifier
rxcui: 309140
unii: P81Q6V85NP
cevimeline hydrochlorideCEVIMELINE HYDROCHLORIDELupin Pharmaceuticals,Inc.0fbcf1a7-5b8b-42fb-b764-4b529e7d1a992024-01-30Warnings, Adverse reactionsExact identifier
rxcui: 309140
unii: P81Q6V85NP
Cevimeline HydrochlorideCEVIMELINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.1167360c-7e0f-4619-9d1a-ad4ee56cab712024-01-08Warnings, Adverse reactionsExact identifier
rxcui: 309140
unii: P81Q6V85NP
Cevimeline HydrochlorideCEVIMELINE HYDROCHLORIDEAurobindo Pharma Limitedd08d8aa5-76a4-417a-a308-7d195865522f2023-04-19Warnings, Adverse reactionsExact identifier
rxcui: 309140
unii: P81Q6V85NP
cevimeline hydrochlorideCEVIMELINE HYDROCHLORIDECosette Pharmaceuticals, Inc.efc2bb24-4dda-4781-bef5-fcd9abf082dd2023-01-05Warnings, Adverse reactionsExact identifier
application number: NDA020989
ndc (product): 0713-0937
rxcui: 309140
spl id: f183f958-57f5-ea10-e053-2995a90a5ead
spl set id: efc2bb24-4dda-4781-bef5-fcd9abf082dd
unii: P81Q6V85NP
EvoxacCEVIMELINE HYDROCHLORIDECosette Pharmaceuticals, Inc.dac32a9b-05b8-42c2-9a29-d885a92794562022-09-07Warnings, Adverse reactionsExact identifier
application number: NDA020989
rxcui: 309140
unii: P81Q6V85NP
CevimelineCEVIMELINESun Pharmaceutical Industries, Inc.773a19e8-4c3e-4414-99a6-aea98c9790ee2022-07-15Warnings, Adverse reactionsExact identifier
application number: NDA020989
rxcui: 309140
unii: P81Q6V85NP
cevimeline hydrochlorideCEVIMELINE HYDROCHLORIDENovel Laboratories, Inc.d7432a48-1142-431e-997f-8419dc7248242016-02-09Warnings, Adverse reactionsExact identifier
rxcui: 309140
unii: P81Q6V85NP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.