FDA.reportPublic FDA data

NDC 69238-1205-02 - Buprenorphine

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
69238-1205
Requested NDC
69238-1205-02
Package NDCs from labels
69238-1205-2, 69238-1205-02
Manufacturer
Amneal Pharmaceuticals NY LLC
Effective date
2026-01-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Buprenorphine - Amneal Pharmaceuticals NY LLCAmneal Pharmaceuticals NY LLC2026-01-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1205-2Buprenorphine1 in 1 POUCHPATCH, EXTENDED RELEASE119
69238-1205-2Buprenorphine4 in 1 CARTONPATCH, EXTENDED RELEASE419

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1205BUPRENORPHINE PATCH, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS NY LLC]18Current NDC, Legacy NDC, 2 package rows20240316_c7d079fb-507f-436f-b794-2171b7d97067.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1205-2EA - Each69238-1205d962c419-d1e4-42e9-bf58-e0a57abaa13a12020-05-08

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 4 · 72 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: FZ989GH94E
SUBLOCADEBUPRENORPHINEIndivior Inc.6189fb21-9432-45f8-8481-0bfaf3ccde952026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 40D3SCR4GZ
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: FZ989GH94E
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: FZ989GH94E
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEBryant Ranch Prepack2063d5bf-b3bc-4e73-9046-7e994446ab502026-06-18Warnings, Adverse reactionsExact identifier
unii: 40D3SCR4GZ
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEBryant Ranch Prepackfc2755a5-3292-4b49-872d-e22c386a4e442026-06-11Warnings, Adverse reactionsExact identifier
unii: 40D3SCR4GZ
BuprenorphineBUPRENORPHINERhodes Pharmaceuticals LLC2738feae-316e-426f-971c-5f142ac01b602026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 904870
rxcui: 1432969
rxcui: 1542997
rxcui: 904880
rxcui: 904876
unii: 40D3SCR4GZ
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: FZ989GH94E
BuprenorphineBUPRENORPHINETeva Pharmaceuticals USA, Inc.36995ce3-b515-447b-baa9-aa14f84060d82026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 904870
rxcui: 1432969
rxcui: 1542997
rxcui: 904880
rxcui: 904876
unii: 40D3SCR4GZ
ButransBUPRENORPHINEKnoa Pharma LLC794aa355-66de-41b8-aedf-f2c40f6bc6642026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 904870
rxcui: 1432969
rxcui: 1542997
rxcui: 904880
rxcui: 904876
unii: 40D3SCR4GZ
iVIZIA Lubricant Eye GelPOVIDONEThea Pharma Inc.1f06ca1a-5270-9a82-e063-6294a90aed642026-04-29WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLPreferred PHarmaceuticals Inc.011473a8-26d5-4661-b3c0-745f9b6aa1d82026-04-29WarningsExact identifier
unii: FZ989GH94E
BuprenorphineBUPRENORPHINEINGENUS PHARMACEUTICALS, LLC186e3be6-8bc0-4bb9-96f5-429d53632f452026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 904870
rxcui: 1432969
rxcui: 1542997
rxcui: 904880
rxcui: 904876
unii: 40D3SCR4GZ
BuprenorphineBUPRENORPHINEAveva Drug Delivery Systems Inc.1aae9b13-7431-42ef-8558-14a2325820e62026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 904870
rxcui: 1432969
rxcui: 1542997
rxcui: 904880
rxcui: 904876
unii: 40D3SCR4GZ
FreshKote Preservative Free Lubricant Eye DropsPOVIDONE, POLYVINYL ALCOHOLEyevance Pharmaceuticalsf51c50c3-43ae-4169-9d2b-22b239461dd12026-04-08WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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