Home NDC 52958-046 OCTREOTIDE ACETATE
Product NDC 52958-046
11-digit product format 529580046
Labeler code 52958
Product ID 52958-046_dc2c72fd-ddb4-4933-8ef2-1edfbe7740f2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name octreotide acetate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler Hainan Shuangcheng Pharmaceuticals Co., Ltd.
Application ANDA217860
Marketing category ANDA
Marketing start 2024-05-02
Substance OCTREOTIDE ACETATE
Active strength 100 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217860-001 OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION 2024-05-02
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 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 A217860-001 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION 2024-05-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217860-001 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION 2024-05-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217860-001 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION 2024-05-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217860-001 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION 2024-05-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217860-001 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION 2024-05-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217860-001 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION 2024-05-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217860-001 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION 2024-05-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217860-001 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2024-05-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217860-001 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION 2024-05-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217860-001 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2024-05-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217860-001 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2024-05-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217860-001 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2024-05-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217860-001 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2024-05-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217860-001 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2024-05-02 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217860-001 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION 2024-05-02 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base OCTREOTIDE ACETATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTREOTIDE ACETATE 100 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312069 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 52958-046-01 OCTREOTIDE ACETATE 1 mL in 1 VIAL, GLASS INJECTION, SOLUTION 1 3 52958-046-10 OCTREOTIDE ACETATE 10 in 1 CARTON INJECTION, SOLUTION 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52958-046 OCTREOTIDE ACETATE INJECTION, SOLUTION [HAINAN SHUANGCHENG PHARMACEUTICALS CO., LTD.] 2 Current NDC, 2 package rows 20241222_ab9b0d3d-4dab-4c5b-9c23-3a14f8fcfcde.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 Units Marketing start Sample Exclude flag Status 52958-046-01 52958004601 1 mL in 1 VIAL, GLASS 1 ml Historical 52958-046-10 52958004610 10 VIAL, GLASS in 1 CARTON (52958-046-10) / 1 mL in 1 VIAL, GLASS (52958-046-01) 2024-05-02 No No Current