Home NDC 50633-340-01 AURLUMYN
Product NDC 50633-340
Requested package NDC 50633-340-01
11-digit product format 506330340
Labeler code 50633
Product ID 50633-340_445e0469-117b-0ed5-e063-6394a90abe40
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ILOPROST
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler BTG International Inc
Application NDA217933
Marketing category NDA
Marketing start 2025-08-01
Substance ILOPROST
Active strength 100 ug/mL
Pharmacologic classes Prostacycline [EPC], Prostaglandins I [CS]
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 N217933-001 AURLUMYN ILOPROST 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217933-001 12409184 2041-08-06 Drug product 2025-09-19 N217933-001 12409183 2044-07-18 U-4263 2025-09-19
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N217933-001 NP 2027-02-13 N217933-001 ODE-465 2031-02-13
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 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 6a51e52b5d6a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N217933-001 12409184 2041-08-06 Drug product 2025-09-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217933-001 12409183 2044-07-18 U-4263 2025-09-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217933-001 12409184 2041-08-06 Drug product 2025-09-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217933-001 12409183 2044-07-18 U-4263 2025-09-19 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217933-001 12409184 2041-08-06 Drug product 2025-09-19 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217933-001 12409183 2044-07-18 U-4263 2025-09-19 a50c72e98297…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base AURLUMYN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ILOPROST 100 ug/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination JED5K35YGL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2680303 Internal RxNorm lookup 2680309 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 50633-340-01 AURLUMYN 1 in 1 CARTON INJECTION, SOLUTION 1 3 50633-340-01 AURLUMYN 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 3
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 Sample Exclude flag Status 50633-340-01 50633034001 1 VIAL, SINGLE-DOSE in 1 CARTON (50633-340-01) / 1 mL in 1 VIAL, SINGLE-DOSE 2025-08-01 No No Current