FDA.reportPublic FDA data

Octreotide Acetate

Product NDC
71288-568
11-digit product format
712880568
Labeler code
71288
Product ID
71288-568_a12a7206-6077-4b61-a038-4aae1170b387
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Octreotide Acetate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Meitheal Pharmaceuticals, Inc.
Application
ANDA075957
Marketing category
ANDA
Marketing start
2025-02-28
Substance
OCTREOTIDE ACETATE
Active strength
500 ug/mL
Pharmacologic classes
Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Octreotide Acetate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTREOTIDE ACETATE500 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii75R0U2568I
Rxcui312068, 312069, 312070

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
813db1d8-6534-4d2d-be9e-8d2c20a55edaProduct name120241217
a6ddfef5-d553-2919-73fa-8aede2a8ab27Product name520240823
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
8f3fde6c-976e-4e4c-8ed4-542294fcc0efProduct name120210115
467fba3a-c020-419e-8102-aeb9c0ea15ecProduct name120200616
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71288-568-01Octreotide Acetate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION11
71288-568-02Octreotide Acetate10 in 1 CARTONINJECTION, SOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-568-01ML - Milliliter71288-5685df528d3-bf8c-4420-97eb-9755a4f5d6a012025-11-13
71288-568-02ML - Milliliter71288-5688ae2002c-6c75-4e00-9083-c748fa6cf72d12025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-568OCTREOTIDE ACETATE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20250228_01962c67-e551-47b6-a276-e1ae1860d2a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312069octreotide 100 MCG in 1 ML InjectionPSN01962c67-e551-47b6-a276-e1ae1860d2a41
312068octreotide 50 MCG in 1 ML InjectionPSN01962c67-e551-47b6-a276-e1ae1860d2a41
312070octreotide 500 MCG in 1 ML InjectionPSN01962c67-e551-47b6-a276-e1ae1860d2a41
3120681 ML octreotide 0.05 MG/ML InjectionSCD01962c67-e551-47b6-a276-e1ae1860d2a41
3120691 ML octreotide 0.1 MG/ML InjectionSCD01962c67-e551-47b6-a276-e1ae1860d2a41
3120701 ML octreotide 0.5 MG/ML InjectionSCD01962c67-e551-47b6-a276-e1ae1860d2a41
3120691 ML octreotide 100 MCG/ML InjectionSY01962c67-e551-47b6-a276-e1ae1860d2a41
3120701 ML octreotide 500 MCG/ML InjectionSY01962c67-e551-47b6-a276-e1ae1860d2a41
312069octreotide 100 MCG per 1 ML InjectionSY01962c67-e551-47b6-a276-e1ae1860d2a41
312068octreotide 50 MCG per 1 ML InjectionSY01962c67-e551-47b6-a276-e1ae1860d2a41
312070octreotide 500 MCG per 1 ML InjectionSY01962c67-e551-47b6-a276-e1ae1860d2a41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71288-568-01712880568011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
71288-568-027128805680210 VIAL, SINGLE-DOSE in 1 CARTON (71288-568-02) / 1 mL in 1 VIAL, SINGLE-DOSE (71288-568-01) 2025-02-28NoNoHistorical