FDA.reportPublic FDA data

Octreotide Acetate

Product NDC
25021-465
11-digit product format
250210465
Labeler code
25021
Product ID
25021-465_5e508c59-4170-441a-a94a-70b0bf28b8e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
octreotide acetate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA090834
Marketing category
ANDA
Marketing start
2023-06-15
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct25021-465IInactivated by FDA2026-07-31
excluded packagepackage25021-46525021-465-01IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090834-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)OCTREOTIDE ACETATEEQ 0.05MG BASE/MLINJECTABLE / INJECTIONAP2013-11-12
A090834-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)OCTREOTIDE ACETATEEQ 0.1MG BASE/MLINJECTABLE / INJECTIONAP2013-11-12
A090834-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)OCTREOTIDE ACETATEEQ 0.5MG BASE/MLINJECTABLE / INJECTIONAP2013-11-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A090834-001AP
A090834-002AP
A090834-003AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A090834-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAP2013-11-12a50c72e98297…
2026-08-01 22:54:322026-06A090834-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAP2013-11-12a50c72e98297…
2026-08-01 22:54:322026-06A090834-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAP2013-11-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090834-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A090834-002AP1a50c72e98297…
2026-08-01 22:54:322026-06A090834-003AP1a50c72e98297…

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
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
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-465-01Octreotide Acetate10 in 1 CARTONINJECTION, SOLUTION1010
25021-465-01Octreotide Acetate1 mL in 1 VIALINJECTION, SOLUTION110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-465-01ML - Milliliter25021-465abccb3c7-3f7d-45c6-9737-38ef3b3b5e6812023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-465OCTREOTIDE ACETATE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]9Current NDC, Legacy NDC, 2 package rows20250221_7ce2fc1e-7520-4d04-be45-2baba32ca24a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312069octreotide 100 MCG in 1 ML InjectionPSN7ce2fc1e-7520-4d04-be45-2baba32ca24a10
312071octreotide 1000 MCG/ML Injectable SolutionPSN7ce2fc1e-7520-4d04-be45-2baba32ca24a10
314152octreotide 200 MCG/ML Injectable SolutionPSN7ce2fc1e-7520-4d04-be45-2baba32ca24a10
312068octreotide 50 MCG in 1 ML InjectionPSN7ce2fc1e-7520-4d04-be45-2baba32ca24a10
312070octreotide 500 MCG in 1 ML InjectionPSN7ce2fc1e-7520-4d04-be45-2baba32ca24a10
3120681 ML octreotide 0.05 MG/ML InjectionSCD7ce2fc1e-7520-4d04-be45-2baba32ca24a10
3120691 ML octreotide 0.1 MG/ML InjectionSCD7ce2fc1e-7520-4d04-be45-2baba32ca24a10
3120701 ML octreotide 0.5 MG/ML InjectionSCD7ce2fc1e-7520-4d04-be45-2baba32ca24a10
314152octreotide 0.2 MG/ML Injectable SolutionSCD7ce2fc1e-7520-4d04-be45-2baba32ca24a10
312071octreotide 1 MG/ML Injectable SolutionSCD7ce2fc1e-7520-4d04-be45-2baba32ca24a10
3120691 ML octreotide 100 MCG/ML InjectionSY7ce2fc1e-7520-4d04-be45-2baba32ca24a10
3120701 ML octreotide 500 MCG/ML InjectionSY7ce2fc1e-7520-4d04-be45-2baba32ca24a10
312071octreotide (as octreotide acetate) 1000 MCG/ML Injectable SolutionSY7ce2fc1e-7520-4d04-be45-2baba32ca24a10
314152octreotide (as octreotide acetate) 200 MCG/ML Injectable SolutionSY7ce2fc1e-7520-4d04-be45-2baba32ca24a10
312069octreotide 100 MCG per 1 ML InjectionSY7ce2fc1e-7520-4d04-be45-2baba32ca24a10
312068octreotide 50 MCG per 1 ML InjectionSY7ce2fc1e-7520-4d04-be45-2baba32ca24a10
312070octreotide 500 MCG per 1 ML InjectionSY7ce2fc1e-7520-4d04-be45-2baba32ca24a10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-465-012502104650110 VIAL in 1 CARTON (25021-465-01) / 1 mL in 1 VIAL10 vial2023-06-150000-00-00NoNoCurrent