FDA.reportPublic FDA data

NDC 68462-896-01 - Octreotide Acetate

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
68462-896
Requested NDC
68462-896-01
Package NDCs from labels
68462-896-01, 68462-896-10
Manufacturer
GLENMARK PHARMACEUTICALS INC., USA | Gland Pharma Limited
Effective date
2026-01-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Octreotide Acetate - GLENMARK PHARMACEUTICALS INC., USA | Gland Pharma LimitedGLENMARK PHARMACEUTICALS INC., USA | Gland Pharma Limited2026-01-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-896-01Octreotide Acetate1 mL in 1 VIALINJECTION, SOLUTION12
68462-896-10Octreotide Acetate10 in 1 CARTONINJECTION, SOLUTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-896OCTREOTIDE ACETATE INJECTION, SOLUTION [GLENMARK PHARMACEUTICALS INC., USA]1Current NDC, 2 package rows20231201_387d7f8d-9762-4f6b-99e1-bdc50b8a1633.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-896-01ML - Milliliter68462-8960318bd09-8e3a-451b-82ab-487ef3a3e13112024-01-04
68462-896-10ML - Milliliter68462-8969b0ea712-8b31-462c-ae6b-15448dacd43812024-01-04

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 15 of 20 · 399 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R
SODIUM BICARBONATESODIUM BICARBONATE INJECTION,Long Grove Pharmaceuticals, LLCa26d709b-b294-4b02-9a88-7e840f099a332024-09-25Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Insect sting relief latex 01SODIUM BICARBONATECosmuses Cosmetics (Ningbo) Co., Ltd.1b9e2d4c-bc0c-6ed0-e063-6294a90a91032024-08-19WarningsExact identifier
unii: 8MDF5V39QO
Quality Choice Effervescent Antacid and Pain Relief - Extra StrengthASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEChain Drug Marketing Association1f926637-a61c-8eb7-e063-6394a90a65022024-08-13WarningsExact identifier
unii: 8MDF5V39QO
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
Omeprazole/Sodiium BicarbonateOMEPRAZOLE/SODIIUM BICARBONATEDirect_rx1f7f63c1-17c2-9a05-e063-6394a90abc6f2024-08-12Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Octreotide AcetateOCTREOTIDE ACETATEGland Pharma Limited884e4287-a4d8-4a6e-8d99-dbe5e88875b92024-07-29Warnings, Adverse reactionsExact identifier
application number: ANDA216839
rxcui: 312070
rxcui: 312069
unii: 75R0U2568I
Octreotide AcetateOCTREOTIDE ACETATEGland Pharma Limited2344ae7a-c2f0-433b-9133-1dcb16bb18a02024-07-25Warnings, Adverse reactionsExact identifier
unii: 75R0U2568I
Octreotide AcetateOCTREOTIDE ACETATEMylan Institutional LLC2d78d5d1-77b2-4da1-98d4-d9c36e743ce22024-07-15Warnings, Adverse reactionsExact identifier
unii: 75R0U2568I
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEDr. Reddy's Laboratories Inc.,ddee28fb-c871-a6d4-984f-515522b284122024-07-15WarningsExact identifier
unii: 8MDF5V39QO
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
Insect sting relief pad 01SODIUM BICARBONATECosmuses Cosmetics (Ningbo) Co., Ltd.1b0f0088-6482-6de7-e063-6294a90aeeb72024-06-17WarningsExact identifier
unii: 8MDF5V39QO
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEANI Pharmaceuticals, Inc.63c3bd6c-a586-4ec0-8f45-ed936936dfeb2024-06-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
OctreotideOCTREOTIDE ACETATEFresenius Kabi USA, LLCd6a9a800-889d-417f-b533-1913197d00222024-05-23Warnings, Adverse reactionsExact identifier
rxcui: 312070
rxcui: 312069
unii: 75R0U2568I
OctreotideOCTREOTIDE ACETATEFresenius Kabi USA, LLCf278f0d8-4062-420a-97c3-3a8b88253a082024-05-07Warnings, Adverse reactionsExact identifier
rxcui: 312070
rxcui: 312069
unii: 75R0U2568I
PEMF OptimizerAQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUMDeseret Biologicals, Inc.97d57469-4c5b-4d3f-9398-3a1a6617a6492024-04-23WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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