FDA.reportPublic FDA data

Octreotide Acetate

Product NDC
68462-896
11-digit product format
684620896
Labeler code
68462
Product ID
68462-896_1a5d8576-7695-42f0-871a-d8de8c7b0220
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Octreotide Acetate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
GLENMARK PHARMACEUTICALS INC., USA
Application
ANDA216839
Marketing category
ANDA
Marketing start
2023-08-09
Substance
OCTREOTIDE ACETATE
Active strength
100 ug/mL
Pharmacologic classes
Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Octreotide Acetate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTREOTIDE ACETATE100 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii75R0U2568I
Rxcui312069, 312070

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
813db1d8-6534-4d2d-be9e-8d2c20a55edaProduct name120241217
a6ddfef5-d553-2919-73fa-8aede2a8ab27Product name520240823
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
8f3fde6c-976e-4e4c-8ed4-542294fcc0efProduct name120210115
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
467fba3a-c020-419e-8102-aeb9c0ea15ecProduct name120200616
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312069octreotide 100 MCG in 1 ML InjectionPSN387d7f8d-9762-4f6b-99e1-bdc50b8a16332
312070octreotide 500 MCG in 1 ML InjectionPSN387d7f8d-9762-4f6b-99e1-bdc50b8a16332
3120691 ML octreotide 0.1 MG/ML InjectionSCD387d7f8d-9762-4f6b-99e1-bdc50b8a16332
3120701 ML octreotide 0.5 MG/ML InjectionSCD387d7f8d-9762-4f6b-99e1-bdc50b8a16332
3120691 ML octreotide 100 MCG/ML InjectionSY387d7f8d-9762-4f6b-99e1-bdc50b8a16332
3120701 ML octreotide 500 MCG/ML InjectionSY387d7f8d-9762-4f6b-99e1-bdc50b8a16332
312069octreotide 100 MCG per 1 ML InjectionSY387d7f8d-9762-4f6b-99e1-bdc50b8a16332
312070octreotide 500 MCG per 1 ML InjectionSY387d7f8d-9762-4f6b-99e1-bdc50b8a16332

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68462-896-01684620896011 mL in 1 VIAL1 mlHistorical
68462-896-106846208961010 VIAL in 1 CARTON (68462-896-10) / 1 mL in 1 VIAL (68462-896-01) 10 vial2023-08-09NoNoCurrent