Octreotide Acetate

Product NDC
0641-6176
11-digit product format
006416176
Labeler code
0641
Product ID
0641-6176_efa5d8e8-57ab-4b56-b8d7-f856ea97404c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Octreotide Acetate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA076313
Marketing category
ANDA
Marketing start
2005-04-04
Substance
OCTREOTIDE ACETATE
Active strength
500 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

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
A076313-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)OCTREOTIDE ACETATEEQ 0.05MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-28
A076313-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)OCTREOTIDE ACETATEEQ 0.5MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-28
A076313-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)OCTREOTIDE ACETATEEQ 0.1MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076313-001AP
A076313-002AP
A076313-003AP

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 UTC2026-02A076313-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076313-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076313-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076313-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076313-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076313-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A076313-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076313-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076313-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076313-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076313-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076313-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076313-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076313-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076313-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076313-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076313-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076313-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076313-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076313-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076313-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076313-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076313-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076313-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076313-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076313-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076313-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076313-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A076313-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A076313-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076313-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076313-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076313-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076313-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076313-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076313-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076313-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076313-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076313-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076313-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAPRS2005-03-288072bd15b7f6…

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 UTC2026-02A076313-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076313-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076313-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076313-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076313-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076313-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076313-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076313-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076313-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076313-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076313-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076313-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076313-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076313-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076313-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076313-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076313-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076313-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076313-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076313-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076313-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076313-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076313-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076313-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076313-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076313-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076313-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076313-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076313-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076313-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076313-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076313-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076313-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076313-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076313-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076313-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076313-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076313-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076313-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076313-001AP18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTREOTIDE ACETATE500 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 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312068Internal RxNorm lookup
312069Internal RxNorm lookup
312070Internal RxNorm lookup
312071Internal RxNorm lookup
314152Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9502860d-0261-4d69-a4be-827a5376d356Available 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
0641-6176-01Octreotide Acetate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION111
0641-6176-10Octreotide Acetate10 in 1 CARTONINJECTION, SOLUTION1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6176-01ML - Milliliter0641-6176f4be80c9-8639-4144-b6eb-d10d82e7ca9912017-11-06
0641-6176-10ML - Milliliter0641-6176358d5f5e-2d41-48e5-a27a-552a2e60e17812017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6176OCTREOTIDE ACETATE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]10Current NDC, Legacy NDC, 2 package rows20250515_9502860d-0261-4d69-a4be-827a5376d356.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 ACETATEHikma Pharmaceuticals USA Inc.9502860d-0261-4d69-a4be-827a5376d3562024-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076313
application number: ANDA076313
ndc (product): 0641-6176

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312069octreotide 100 MCG in 1 ML InjectionPSN9502860d-0261-4d69-a4be-827a5376d35611
312071octreotide 1000 MCG/ML Injectable SolutionPSN9502860d-0261-4d69-a4be-827a5376d35611
314152octreotide 200 MCG/ML Injectable SolutionPSN9502860d-0261-4d69-a4be-827a5376d35611
312068octreotide 50 MCG in 1 ML InjectionPSN9502860d-0261-4d69-a4be-827a5376d35611
312070octreotide 500 MCG in 1 ML InjectionPSN9502860d-0261-4d69-a4be-827a5376d35611
3120681 ML octreotide 0.05 MG/ML InjectionSCD9502860d-0261-4d69-a4be-827a5376d35611
3120691 ML octreotide 0.1 MG/ML InjectionSCD9502860d-0261-4d69-a4be-827a5376d35611
3120701 ML octreotide 0.5 MG/ML InjectionSCD9502860d-0261-4d69-a4be-827a5376d35611
314152octreotide 0.2 MG/ML Injectable SolutionSCD9502860d-0261-4d69-a4be-827a5376d35611
312071octreotide 1 MG/ML Injectable SolutionSCD9502860d-0261-4d69-a4be-827a5376d35611
3120691 ML octreotide 100 MCG/ML InjectionSY9502860d-0261-4d69-a4be-827a5376d35611
3120701 ML octreotide 500 MCG/ML InjectionSY9502860d-0261-4d69-a4be-827a5376d35611
312071octreotide (as octreotide acetate) 1000 MCG/ML Injectable SolutionSY9502860d-0261-4d69-a4be-827a5376d35611
314152octreotide (as octreotide acetate) 200 MCG/ML Injectable SolutionSY9502860d-0261-4d69-a4be-827a5376d35611
312069octreotide 100 MCG per 1 ML InjectionSY9502860d-0261-4d69-a4be-827a5376d35611
312068octreotide 50 MCG per 1 ML InjectionSY9502860d-0261-4d69-a4be-827a5376d35611
312070octreotide 500 MCG per 1 ML InjectionSY9502860d-0261-4d69-a4be-827a5376d35611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-6176-01006416176011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
0641-6176-100064161761010 VIAL, SINGLE-DOSE in 1 CARTON (0641-6176-10) / 1 mL in 1 VIAL, SINGLE-DOSE (0641-6176-01) 2005-04-040000-00-00NoNoCurrent