Home NDC 63323-378 Octreotide
Product NDC 63323-378
11-digit product format 633230378
Labeler code 63323
Product ID 63323-378_02ac0091-573d-41ba-8b4d-5a1d42b89b2e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name OCTREOTIDE ACETATE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA077450
Marketing category ANDA
Marketing start 2006-03-14
Substance OCTREOTIDE ACETATE
Active strength 200 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077450-001 OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 A077450-002 OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A077450-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077450-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077450-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077450-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077450-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077450-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077450-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077450-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077450-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077450-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077450-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077450-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077450-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077450-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077450-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077450-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077450-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077450-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077450-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077450-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077450-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077450-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077450-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077450-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077450-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077450-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077450-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077450-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077450-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077450-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077450-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077450-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077450-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077450-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077450-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077450-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077450-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077450-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077450-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A077450-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2006-02-10 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Octreotide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTREOTIDE ACETATE 200 ug/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 75R0U2568I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312069 Internal RxNorm lookup 312070 Internal RxNorm lookup 312071 Internal RxNorm lookup 314152 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63323-378-05 Octreotide 5 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 5 9 63323-378-05 Octreotide 1 in 1 CARTON INJECTION, SOLUTION 1 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OCTREOTIDE ACETATE ACTIVE INGREDIENT 75R0U2568I OCTREOTIDE (OCTREOTIDE ACETATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 2 OCTREOTIDE ACTIVE MOIETY RWM8CCW8GP OCTREOTIDE (OCTREOTIDE ACETATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 2 ACETIC ACID INACTIVE INGREDIENT Q40Q9N063P OCTREOTIDE (OCTREOTIDE ACETATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 2 PHENOL INACTIVE INGREDIENT 339NCG44TV OCTREOTIDE (OCTREOTIDE ACETATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 2 SODIUM ACETATE INACTIVE INGREDIENT 4550K0SC9B OCTREOTIDE (OCTREOTIDE ACETATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 2 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X OCTREOTIDE (OCTREOTIDE ACETATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-378 OCTREOTIDE (OCTREOTIDE ACETATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 9 Current NDC, Legacy NDC, 2 package rows 20240518_f278f0d8-4062-420a-97c3-3a8b88253a08.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63323-378-05 63323037805 1 VIAL, MULTI-DOSE in 1 CARTON (63323-378-05) / 5 mL in 1 VIAL, MULTI-DOSE 2006-03-14 0000-00-00 No No Current