Octreotide Acetate

Product NDC
67457-239
11-digit product format
674570239
Labeler code
67457
Product ID
67457-239_1bb19829-029a-4baf-a12c-ec04102dd79e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
octreotide acetate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Mylan Institutional LLC
Application
ANDA079198
Marketing category
ANDA
Marketing start
2011-04-01
Substance
OCTREOTIDE ACETATE
Active strength
50 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

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
A079198-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)OCTREOTIDE ACETATEEQ 0.05MG BASE/MLINJECTABLE / INJECTIONAP2011-02-10
A079198-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)OCTREOTIDE ACETATEEQ 0.1MG BASE/MLINJECTABLE / INJECTIONAP2011-02-10
A079198-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)OCTREOTIDE ACETATEEQ 0.5MG BASE/MLINJECTABLE / INJECTIONAP2011-02-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A079198-001AP
A079198-002AP
A079198-003AP

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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A079198-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAP2011-02-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079198-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAP2011-02-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079198-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAP2011-02-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079198-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAP2011-02-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079198-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAP2011-02-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079198-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAP2011-02-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A079198-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAP2011-02-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079198-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAP2011-02-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079198-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAP2011-02-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079198-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAP2011-02-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079198-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAP2011-02-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079198-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAP2011-02-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079198-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAP2011-02-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079198-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAP2011-02-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079198-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAP2011-02-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079198-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAP2011-02-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079198-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAP2011-02-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079198-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAP2011-02-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079198-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAP2011-02-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079198-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAP2011-02-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079198-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAP2011-02-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079198-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAP2011-02-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079198-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAP2011-02-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079198-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAP2011-02-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079198-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAP2011-02-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079198-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAP2011-02-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079198-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAP2011-02-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079198-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAP2011-02-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A079198-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAP2011-02-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A079198-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAP2011-02-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079198-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAP2011-02-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079198-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAP2011-02-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079198-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAP2011-02-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079198-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAP2011-02-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079198-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAP2011-02-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079198-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAP2011-02-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079198-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAP2011-02-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079198-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAP2011-02-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079198-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAP2011-02-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079198-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAP2011-02-108072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A079198-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079198-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079198-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079198-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079198-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079198-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A079198-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079198-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079198-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079198-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079198-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079198-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079198-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079198-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079198-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079198-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079198-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079198-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079198-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079198-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079198-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079198-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079198-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079198-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079198-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079198-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079198-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079198-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A079198-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A079198-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079198-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079198-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079198-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079198-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079198-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079198-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079198-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079198-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079198-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079198-001AP18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTREOTIDE ACETATE50 ug/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
75R0U2568IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1090558Internal RxNorm lookup
1090559Internal RxNorm lookup
1090560Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2d78d5d1-77b2-4da1-98d4-d9c36e743ce2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
813db1d8-6534-4d2d-be9e-8d2c20a55edaProduct name120241217
a6ddfef5-d553-2919-73fa-8aede2a8ab27Product name520240823
8f3fde6c-976e-4e4c-8ed4-542294fcc0efProduct name120210115
467fba3a-c020-419e-8102-aeb9c0ea15ecProduct name120200616

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-239-00Octreotide Acetate1 mL in 1 SYRINGEINJECTION, SOLUTION120
67457-239-01Octreotide Acetate10 in 1 CARTONINJECTION, SOLUTION1020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-239-00ML - Milliliter67457-239aead6cb6-5cfd-41a4-87fc-4c118fe8240412013-08-02
67457-239-01ML - Milliliter67457-239eb1e9610-9b93-4838-bff5-5b2698ff22e612012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-239OCTREOTIDE ACETATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]20Current NDC, Legacy NDC, 2 package rows20241215_2d78d5d1-77b2-4da1-98d4-d9c36e743ce2.zip

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Octreotide AcetateOCTREOTIDE ACETATEMylan Institutional LLC2d78d5d1-77b2-4da1-98d4-d9c36e743ce22024-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079198
application number: ANDA079198
ndc (product): 67457-239

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1090558octreotide 100 MCG in 1 ML Prefilled SyringePSN2d78d5d1-77b2-4da1-98d4-d9c36e743ce220
1090559octreotide 50 MCG in 1 ML Prefilled SyringePSN2d78d5d1-77b2-4da1-98d4-d9c36e743ce220
1090560octreotide 500 MCG in 1 ML Prefilled SyringePSN2d78d5d1-77b2-4da1-98d4-d9c36e743ce220
10905591 ML octreotide 0.05 MG/ML Prefilled SyringeSCD2d78d5d1-77b2-4da1-98d4-d9c36e743ce220
10905581 ML octreotide 0.1 MG/ML Prefilled SyringeSCD2d78d5d1-77b2-4da1-98d4-d9c36e743ce220
10905601 ML octreotide 0.5 MG/ML Prefilled SyringeSCD2d78d5d1-77b2-4da1-98d4-d9c36e743ce220
1090558octreotide (as octreotide acetate) 100 MCG per 1 ML Prefilled SyringeSY2d78d5d1-77b2-4da1-98d4-d9c36e743ce220
1090559octreotide (as octreotide acetate) 50 MCG per 1 ML Prefilled SyringeSY2d78d5d1-77b2-4da1-98d4-d9c36e743ce220
1090560octreotide (as octreotide acetate) 500 MCG per 1 ML Prefilled SyringeSY2d78d5d1-77b2-4da1-98d4-d9c36e743ce220
1090559octreotide 50 MCG per 1 ML Prefilled SyringeSY2d78d5d1-77b2-4da1-98d4-d9c36e743ce220

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-239-00674570239001 mL in 1 SYRINGE1 mlHistorical
67457-239-016745702390110 SYRINGE in 1 CARTON (67457-239-01) / 1 mL in 1 SYRINGE (67457-239-00) 10 syringe2011-04-010000-00-00NoNoCurrent