FDA.reportPublic FDA data

NDC 63629-2093-01 - Levorphanol Tartrate

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
63629-2093
Requested NDC
63629-2093-01
Package NDCs from labels
63629-2093-1, 63629-2093-01
Manufacturer
Bryant Ranch Prepack
Effective date
2026-03-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levorphanol Tartrate - Bryant Ranch PrepackBryant Ranch Prepack2026-03-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-2093-1Levorphanol Tartrate100 in 1 BOTTLETABLET100106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2093LEVORPHANOL TARTRATE TABLET [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 1 package rows20240816_d7587868-561c-4e04-b02c-36a4b653a762.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2093-1EA - Each63629-2093a39af356-0226-494d-bd5c-e6b2ac9f040312021-03-02

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 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levorphanol TartrateLEVORPHANOL TARTRATESpecGx LLC759c7040-0be0-4d17-be97-e467e423eaa82026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197873
unii: 04WQU6T9QI
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
Levorphanol TartrateLEVORPHANOL TARTRATEBryant Ranch Prepackd7587868-561c-4e04-b02c-36a4b653a7622026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA213479
ndc (package): 63629-2093-1
ndc (product): 63629-2093
ndc11 (package): 63629209301
rxcui: 197873
spl id: 46b0156b-828d-4997-bc71-e4e5471b9883
spl set id: d7587868-561c-4e04-b02c-36a4b653a762
unii: 04WQU6T9QI
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Levorphanol TartrateLEVORPHANOL TARTRATESun Pharmaceutical Industries, Inc.438cf3ea-04fe-4626-9f0f-adcda76336512026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2058845
rxcui: 197873
unii: 04WQU6T9QI
Levorphanol TartrateLEVORPHANOL TARTRATELannett Company, Inc.a50debe1-90b3-4931-9ec0-67e88dd21b042026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA213479
ndc (product): 0527-3236
rxcui: 2058845
rxcui: 197873
spl id: a0edf042-6bef-434f-bd7e-ca4a899c1841
spl set id: a50debe1-90b3-4931-9ec0-67e88dd21b04
unii: 04WQU6T9QI
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
LEVORPHANOL TARTRATELEVORPHANOL TARTRATEHikma Pharmaceuticals USA Inc.b2ab70e4-ca0c-4a73-9c98-974bf94e890c2025-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197873
unii: 04WQU6T9QI
Levorphanol TartrateLEVORPHANOL TARTRATEBryant Ranch Prepackdeed8652-9b9d-48b4-8c3e-9fdd7c46237e2025-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197873
unii: 04WQU6T9QI
Levorphanol TartrateLEVORPHANOL TARTRATEVirtus Pharmaceuticals, LLC6e7ca993-c8b9-4510-a2b0-5bcc678d25712025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197873
unii: 04WQU6T9QI
Levorphanol TartrateLEVORPHANOL TARTRATEACERTIS PHARMACEUTICALS, LLC113a713f-830b-481c-bfa6-d44e3ac27f802025-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197873
unii: 04WQU6T9QI
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ

Reported adverse events (FAERS/openFDA)#

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