Octreotide Acetate

Product NDC
0480-9262
11-digit product format
004809262
Labeler code
0480
Product ID
0480-9262_2e77a034-b0ae-4694-8ac0-ae1319754d3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Octreotide Acetate
Dosage form
KIT
Route
INTRAMUSCULAR
Labeler
Teva Pharmaceuticals, Inc.
Application
ANDA210317
Marketing category
ANDA
Marketing start
2024-10-01
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0480-9262-082ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0480-9262-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0480-9262-08cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0480-9262-08cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0480-9262-08302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0480-9262-08ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0480-9262-080efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0480-9262-08ad56d346431e…cc804d4bbf1e…

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
A210317-001OCTREOTIDE ACETATEOCTREOTIDE ACETATEEQ 10MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-05
A210317-002OCTREOTIDE ACETATEOCTREOTIDE ACETATEEQ 20MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-05
A210317-003OCTREOTIDE ACETATEOCTREOTIDE ACETATEEQ 30MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210317-001AB
A210317-002AB
A210317-003AB

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 2 · 54 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210317-001OCTREOTIDE ACETATEEQ 10MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210317-002OCTREOTIDE ACETATEEQ 20MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210317-003OCTREOTIDE ACETATEEQ 30MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210317-001OCTREOTIDE ACETATEEQ 10MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210317-002OCTREOTIDE ACETATEEQ 20MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210317-003OCTREOTIDE ACETATEEQ 30MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A210317-001OCTREOTIDE ACETATEEQ 10MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210317-002OCTREOTIDE ACETATEEQ 20MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210317-003OCTREOTIDE ACETATEEQ 30MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210317-001OCTREOTIDE ACETATEEQ 10MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210317-002OCTREOTIDE ACETATEEQ 20MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210317-003OCTREOTIDE ACETATEEQ 30MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210317-001OCTREOTIDE ACETATEEQ 10MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210317-002OCTREOTIDE ACETATEEQ 20MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210317-003OCTREOTIDE ACETATEEQ 30MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210317-001OCTREOTIDE ACETATEEQ 10MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210317-002OCTREOTIDE ACETATEEQ 20MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210317-003OCTREOTIDE ACETATEEQ 30MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210317-001OCTREOTIDE ACETATEEQ 10MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210317-002OCTREOTIDE ACETATEEQ 20MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210317-003OCTREOTIDE ACETATEEQ 30MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210317-001OCTREOTIDE ACETATEEQ 10MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210317-002OCTREOTIDE ACETATEEQ 20MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210317-003OCTREOTIDE ACETATEEQ 30MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210317-001OCTREOTIDE ACETATEEQ 10MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210317-002OCTREOTIDE ACETATEEQ 20MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210317-003OCTREOTIDE ACETATEEQ 30MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210317-001OCTREOTIDE ACETATEEQ 10MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A210317-002OCTREOTIDE ACETATEEQ 20MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A210317-003OCTREOTIDE ACETATEEQ 30MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210317-001OCTREOTIDE ACETATEEQ 10MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210317-002OCTREOTIDE ACETATEEQ 20MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210317-003OCTREOTIDE ACETATEEQ 30MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210317-001OCTREOTIDE ACETATEEQ 10MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210317-002OCTREOTIDE ACETATEEQ 20MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210317-003OCTREOTIDE ACETATEEQ 30MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210317-001OCTREOTIDE ACETATEEQ 10MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210317-002OCTREOTIDE ACETATEEQ 20MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210317-003OCTREOTIDE ACETATEEQ 30MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210317-001OCTREOTIDE ACETATEEQ 10MG BASE/VIALINJECTABLE / INJECTIONAB2023-12-058072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210317-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210317-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210317-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210317-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210317-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210317-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210317-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210317-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210317-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210317-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210317-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210317-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210317-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210317-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210317-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210317-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210317-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210317-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210317-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210317-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210317-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210317-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210317-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210317-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210317-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210317-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210317-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210317-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210317-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210317-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210317-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210317-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210317-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210317-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210317-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210317-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210317-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210317-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210317-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210317-001AB18072bd15b7f6…

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
898589Internal RxNorm lookup
898601Internal RxNorm lookup
898605Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d9739ea6-74de-4a41-a806-6e827a23cedbAvailable 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
0480-9262-08Octreotide Acetate1 in 1 KITKIT15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0480-9262-08EA - Each0480-926226f8a9b1-5f01-45ec-aac0-62fed13f574712024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0480-9262OCTREOTIDE ACETATE KIT [TEVA PHARMACEUTICALS, INC.]5Current NDC, 1 package rows20250323_d9739ea6-74de-4a41-a806-6e827a23cedb.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 ACETATETeva Pharmaceuticals, Inc.d9739ea6-74de-4a41-a806-6e827a23cedb2024-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210317
application number: ANDA210317
ndc (product): 0480-9262

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898605octreotide LAR 10 MG InjectionPSNd9739ea6-74de-4a41-a806-6e827a23cedb5
898589octreotide LAR 20 MG InjectionPSNd9739ea6-74de-4a41-a806-6e827a23cedb5
898601octreotide LAR 30 MG InjectionPSNd9739ea6-74de-4a41-a806-6e827a23cedb5
898605octreotide 10 MG InjectionSCDd9739ea6-74de-4a41-a806-6e827a23cedb5
898589octreotide 20 MG InjectionSCDd9739ea6-74de-4a41-a806-6e827a23cedb5
898601octreotide 30 MG InjectionSCDd9739ea6-74de-4a41-a806-6e827a23cedb5
898605octreotide (as octreotide acetate) 10 MG InjectionSYd9739ea6-74de-4a41-a806-6e827a23cedb5
898589octreotide (as octreotide acetate) 20 MG InjectionSYd9739ea6-74de-4a41-a806-6e827a23cedb5
898601octreotide (as octreotide acetate) 30 MG InjectionSYd9739ea6-74de-4a41-a806-6e827a23cedb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0480-9262-08004809262081 KIT in 1 KIT (0480-9262-08) * 8 mL in 1 VIAL, SINGLE-DOSE (0480-9260-01) * 2 mL in 1 SYRINGE (0480-9263-21) 1 kit2024-10-01NoNoCurrent