FDA.reportPublic FDA data

NDC 63629-9863-02 - 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
63629-9863
Requested NDC
63629-9863-02
Package NDCs from labels
63629-9863-1, 63629-9863-2, 63629-9863-3, 63629-9863-02
Manufacturer
Bryant Ranch Prepack
Effective date
2024-09-05
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 Prepack2024-09-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-9863-1Cevimeline Hydrochloride30 in 1 BOTTLECAPSULE30101
63629-9863-2Cevimeline Hydrochloride60 in 1 BOTTLECAPSULE60101
63629-9863-3Cevimeline Hydrochloride90 in 1 BOTTLECAPSULE90101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9863CEVIMELINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]101Current NDC, 3 package rows20240913_51307f82-66f2-41c7-80ff-174d7e50f7ee.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9863-1EA - Each63629-9863dc6efff2-3a08-4114-abf8-c6aba17ff3aa12025-08-11

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
rxcui: 309140
unii: P81Q6V85NP
Cevimeline HydrochlorideCEVIMELINE HYDROCHLORIDEASCLEMED USA INC.bcaaec18-4ee1-4cfd-84da-8fe3b8c54fc42026-05-18Warnings, Adverse reactionsExact identifier
application number: ANDA203775
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
application number: ANDA203775
ndc (package): 63629-9863-3
ndc (package): 63629-9863-1
ndc (package): 63629-9863-2
ndc (product): 63629-9863
ndc11 (package): 63629986302
rxcui: 309140
spl id: b8a8d949-15e3-4dc7-afd2-c9621a5c7c83
spl set id: 51307f82-66f2-41c7-80ff-174d7e50f7ee
unii: P81Q6V85NP
Cevimeline HydrochlorideCEVIMELINE HYDROCHLORIDERising Pharma Holdings, Inc.d4bd942a-1339-40c5-8fd4-850da5a696352024-08-02Warnings, Adverse reactionsExact identifier
application number: ANDA203775
ndc (product): 16571-657
rxcui: 309140
spl id: 640e50a9-48ba-45e3-a3cb-c14bb313cc4f
spl set id: d4bd942a-1339-40c5-8fd4-850da5a69635
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
rxcui: 309140
unii: P81Q6V85NP
EvoxacCEVIMELINE HYDROCHLORIDECosette Pharmaceuticals, Inc.dac32a9b-05b8-42c2-9a29-d885a92794562022-09-07Warnings, Adverse reactionsExact identifier
rxcui: 309140
unii: P81Q6V85NP
CevimelineCEVIMELINESun Pharmaceutical Industries, Inc.773a19e8-4c3e-4414-99a6-aea98c9790ee2022-07-15Warnings, Adverse reactionsExact identifier
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.