Home NDC 45567-0755 Kit for the Preparation of Indium In 111 Pentetreotide
Product NDC 45567-0755
11-digit product format 455670755
Labeler code 45567
Product ID 45567-0755_334fde6d-c2c2-0054-e063-6394a90a26f0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Indium In-111 Pentetreotide
Dosage form KIT
Route INTRAVENOUS
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA212785
Marketing category ANDA
Marketing start 2025-03-25
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 A212785-001 INDIUM IN-111 PENTETREOTIDE KIT INDIUM IN-111 PENTETREOTIDE KIT 3mCi/ML INJECTABLE / INJECTION 2024-07-01
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 A212785-001 INDIUM IN-111 PENTETREOTIDE KIT 3mCi/ML INJECTABLE / INJECTION AP 2024-07-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212785-001 INDIUM IN-111 PENTETREOTIDE KIT 3mCi/ML INJECTABLE / INJECTION AP 2024-07-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212785-001 INDIUM IN-111 PENTETREOTIDE KIT 3mCi/ML INJECTABLE / INJECTION AP 2024-07-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212785-001 INDIUM IN-111 PENTETREOTIDE KIT 3mCi/ML INJECTABLE / INJECTION AP 2024-07-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212785-001 INDIUM IN-111 PENTETREOTIDE KIT 3mCi/ML INJECTABLE / INJECTION AP 2024-07-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212785-001 INDIUM IN-111 PENTETREOTIDE KIT 3mCi/ML INJECTABLE / INJECTION AP 2024-07-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212785-001 INDIUM IN-111 PENTETREOTIDE KIT 3mCi/ML INJECTABLE / INJECTION AP 2024-07-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212785-001 INDIUM IN-111 PENTETREOTIDE KIT 3mCi/ML INJECTABLE / INJECTION AP 2024-07-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212785-001 INDIUM IN-111 PENTETREOTIDE KIT 3mCi/ML INJECTABLE / INJECTION AP 2024-07-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212785-001 INDIUM IN-111 PENTETREOTIDE KIT 3mCi/ML INJECTABLE / INJECTION AP 2024-07-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212785-001 INDIUM IN-111 PENTETREOTIDE KIT 3mCi/ML INJECTABLE / INJECTION AP 2024-07-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212785-001 INDIUM IN-111 PENTETREOTIDE KIT 3mCi/ML INJECTABLE / INJECTION AP 2024-07-01 301d65b070ca…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212785-001 INDIUM IN-111 PENTETREOTIDE KIT 3mCi/ML INJECTABLE / INJECTION 2024-07-01 a50c72e98297…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 45567-0753-1 Kit for the Preparation of Indium In 111 Pentetreotide 1 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 1 mL 10 ug in 1mL 12 45567-0755-3 Kit for the Preparation of Indium In 111 Pentetreotide 1 in 1 KIT KIT 1 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45567-0755 KIT FOR THE PREPARATION OF INDIUM IN 111 PENTETREOTIDE (INDIUM IN-111 PENTETREOTIDE) KIT [SUN PHARMACEUTICAL INDUSTRIES, INC.] 12 Current NDC, 2 package rows 20250424_e2117bbd-9db3-4d20-a5da-89551c18a0cb.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 45567-0753-1 45567075301 1 mL in 1 VIAL 1 ml Historical 45567-0755-3 45567075503 1 KIT in 1 KIT (45567-0755-3) * 1 mL in 1 VIAL (45567-0752-1) * 1 mL in 1 VIAL (45567-0753-1) 1 kit 2025-03-25 No No Historical