FDA.reportPublic FDA data

NDC 68462-897-01 - 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
68462-897
Requested NDC
68462-897-01
Package NDCs from labels
68462-897-01, 68462-897-10
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
68462-897-01Octreotide Acetate1 mL in 1 VIALINJECTION, SOLUTION12
68462-897-10Octreotide Acetate10 in 1 CARTONINJECTION, SOLUTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-897OCTREOTIDE 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
68462-897-01ML - Milliliter68462-897182881eb-4339-4a25-9509-0af61253f70612024-01-04
68462-897-10ML - Milliliter68462-897bc9d2d4d-90c6-432f-8b5b-05c963a3467d12024-01-04

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 4 of 20 · 399 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Bicarbonate 10 gr. (650 mg)SODIUM BICARBONATEGendose Pharmaceuticals, LLC0a0cc46d-372e-4175-932a-065e82d8d3532026-04-13WarningsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEHospira, Inc.ea9f4498-0d43-4043-8dd1-f22537841c212026-04-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEHospira, Inc.8664c7ce-707b-4c6c-9ce4-7160b5f877f82026-04-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Omeprazole/BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEProficient Rx LP4d642036-7175-4f29-9f07-dbd282231d4a2026-04-01Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Rapidol Sodium BicarbonateSODIUM BICARBONATEPharmadel LLCb4c9a653-6f51-7c98-e053-2995a90ada372026-03-26WarningsExact identifier
unii: 8MDF5V39QO
Sodium Bicarbonate AntacidSODIUM BICARBONATEAphena Pharma Solutions - Tennessee, LLCbba7d5bf-c94b-4ee4-a399-9a2818d84c782026-03-23WarningsExact identifier
unii: 8MDF5V39QO
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
equate omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEWALMART INC.c24c3326-99da-4c7d-aecc-7b4a8ac3f04e2026-03-15WarningsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATEHospira, Inc.084f5572-8c1f-4802-b179-ca0cc838fc682026-03-09Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEHospira, Inc.0c24b592-4bc8-456f-acac-9c9525844a062026-03-09Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
Sodium Bicarbonate 5 grSODIUM BICARBONATETWIN MED LLC12cad432-99db-4a9b-8619-82794e29409e2026-03-01WarningsExact identifier
unii: 8MDF5V39QO
Leader Extra Strength Effervescent Antacid and Pain RelieverASPIRIN, CITRIC ACID, SODIUM BICARBONATECardinal Healthc5d7bf5f-3e59-52f2-e053-2a95a90a4a002026-02-25WarningsExact identifier
unii: 8MDF5V39QO
iShanCare Vaginal Antibacterial GelISHANCARE VAGINAL ANTIBACTERIAL GELShenzhen Ishan Technology Co., Ltd254a6624-80b6-b089-e063-6294a90a887e2026-02-12WarningsExact identifier
unii: 33X04XA5AT
SODIUM BICARBONATESODIUM BICARBONATEAmneal Pharmaceuticals Private Limitedba92f45a-0187-4709-aa70-462b8dae09e92026-02-09Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Octreotide AcetateOCTREOTIDE ACETATEGLENMARK PHARMACEUTICALS INC., USA387d7f8d-9762-4f6b-99e1-bdc50b8a16332026-01-30Warnings, Adverse reactionsExact identifier
application number: ANDA216839
ndc (package): 68462-897-10
ndc (package): 68462-896-01
ndc (package): 68462-896-10
ndc (package): 68462-897-01
ndc (product): 68462-896
ndc (product): 68462-897
ndc11 (package): 68462089701
rxcui: 312070
rxcui: 312069
spl id: 1a5d8576-7695-42f0-871a-d8de8c7b0220
spl set id: 387d7f8d-9762-4f6b-99e1-bdc50b8a1633
unii: 75R0U2568I
ADRIAN BICARBONATO SODIUM BICARBONATE USP-4 oz, 8 oz and 16 ozSODIUM BICARBONATEEvi Labs4979a339-4ad4-9cdd-e063-6394a90a0acc2026-01-28WarningsExact identifier
unii: 8MDF5V39QO
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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