Home NDC 81153-100 ORLYNVAH
Product NDC 81153-100
11-digit product format 811530100
Labeler code 81153
Product ID 81153-100_abcb22dd-7c10-4459-a98c-d03582b426a3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sulopenem etzadroxil and probenecid
Dosage form TABLET, FILM COATED
Route ORAL
Labeler ITERUM THERAPEUTICS US LIMITED
Application NDA213972
Marketing category NDA
Marketing start 2025-07-01
Substance PROBENECID; SULOPENEM ETZADROXIL
Active strength 500; 500 mg/1; mg/1
NDC exclude flag No
Listing certified through 2027-12-31
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 N213972-001 ORLYNVAH PROBENECID; SULOPENEM ETZADROXIL 500MG;500MG TABLET / ORAL RLD, RS 2024-10-25
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213972-001 7795243 2029-06-03 U-4026 Drug substance, Drug product 2024-11-12 N213972-001 11554112 2039-04-01 U-4026 2024-11-12 N213972-001 12109197 2039-04-01 U-4026 2024-11-12 N213972-001 11478428 2039-12-23 U-4026 Drug product 2024-11-12 N213972-001 12544337 2039-12-23 U-4026 Drug product 2026-02-19
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213972-001 NCE 2029-10-25 N213972-001 GAIN 2034-10-25
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 N213972-001 ORLYNVAH 500MG;500MG TABLET / ORAL RLD, RS 2024-10-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213972-001 ORLYNVAH 500MG;500MG TABLET / ORAL RLD, RS 2024-10-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213972-001 ORLYNVAH 500MG;500MG TABLET / ORAL RLD 2024-10-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213972-001 ORLYNVAH 500MG;500MG TABLET / ORAL RLD, RS 2024-10-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213972-001 ORLYNVAH 500MG;500MG TABLET / ORAL RLD, RS 2024-10-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213972-001 ORLYNVAH 500MG;500MG TABLET / ORAL RLD, RS 2024-10-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213972-001 ORLYNVAH 500MG;500MG TABLET / ORAL RLD, RS 2024-10-25 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213972-001 ORLYNVAH 500MG;500MG TABLET / ORAL RLD, RS 2024-10-25 d8e5a09893c0…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213972-001 ORLYNVAH 500MG;500MG TABLET / ORAL RLD, RS 2024-10-25 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 N213972-001 7795243 2029-06-03 U-4026 Drug substance, Drug product 2024-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213972-001 11554112 2039-04-01 U-4026 2024-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213972-001 12109197 2039-04-01 U-4026 2024-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213972-001 11478428 2039-12-23 U-4026 Drug product 2024-11-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213972-001 7795243 2029-06-03 U-4026 Drug substance, Drug product 2024-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213972-001 11554112 2039-04-01 U-4026 2024-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213972-001 12109197 2039-04-01 U-4026 2024-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213972-001 11478428 2039-12-23 U-4026 Drug product 2024-11-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213972-001 7795243 2029-06-03 U-4026 Drug substance, Drug product 2024-11-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213972-001 11554112 2039-04-01 U-4026 2024-11-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213972-001 12109197 2039-04-01 U-4026 2024-11-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213972-001 11478428 2039-12-23 U-4026 Drug product 2024-11-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213972-001 7795243 2029-06-03 U-4026 Drug substance, Drug product 2024-11-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213972-001 11554112 2039-04-01 U-4026 2024-11-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213972-001 12109197 2039-04-01 U-4026 2024-11-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213972-001 11478428 2039-12-23 U-4026 Drug product 2024-11-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213972-001 7795243 2029-06-03 U-4026 Drug substance, Drug product 2024-11-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213972-001 11554112 2039-04-01 U-4026 2024-11-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213972-001 12109197 2039-04-01 U-4026 2024-11-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213972-001 11478428 2039-12-23 U-4026 Drug product 2024-11-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213972-001 7795243 2029-06-03 U-4026 Drug substance, Drug product 2024-11-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213972-001 11554112 2039-04-01 U-4026 2024-11-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213972-001 12109197 2039-04-01 U-4026 2024-11-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213972-001 11478428 2039-12-23 U-4026 Drug product 2024-11-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213972-001 7795243 2029-06-03 U-4026 Drug substance, Drug product 2024-11-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213972-001 11554112 2039-04-01 U-4026 2024-11-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213972-001 12109197 2039-04-01 U-4026 2024-11-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213972-001 11478428 2039-12-23 U-4026 Drug product 2024-11-12 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213972-001 7795243 2029-06-03 U-4026 Drug substance, Drug product 2024-11-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213972-001 11554112 2039-04-01 U-4026 2024-11-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213972-001 12109197 2039-04-01 U-4026 2024-11-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213972-001 11478428 2039-12-23 U-4026 Drug product 2024-11-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213972-001 12544337 2039-12-23 U-4026 Drug product 2026-02-19 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-02-19 14:30 UTC 2026-02 N213972-001 NCE 2029-10-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213972-001 GAIN 2034-10-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213972-001 NCE 2029-10-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213972-001 GAIN 2034-10-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213972-001 NCE 2029-10-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213972-001 GAIN 2034-10-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213972-001 NCE 2029-10-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213972-001 GAIN 2034-10-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213972-001 NCE 2029-10-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213972-001 GAIN 2034-10-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213972-001 NCE 2029-10-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213972-001 GAIN 2034-10-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213972-001 NCE 2029-10-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213972-001 GAIN 2034-10-25 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213972-001 NCE 2029-10-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213972-001 GAIN 2034-10-25 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base ORLYNVAH
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SULOPENEM ETZADROXIL 500 mg/1 PROBENECID 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 492M3I304T Internal UNII lookup PO572Z7917 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2717843 Internal RxNorm lookup 2717850 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 81153-100-01 ORLYNVAH 1 in 1 CARTON TABLET, FILM COATED 1 6 81153-100-01 ORLYNVAH 10 in 1 BOTTLE TABLET, FILM COATED 10 6
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ORLYNVAH SULOPENEM ETZADROXIL AND PROBENECID ITERUM THERAPEUTICS US LIMITED 24c451c0-4cfb-37f3-e063-6394a90a895e 2025-12-06 Warnings, Adverse reactions Exact identifier application applno (NDA): 213972 application number: NDA213972 ndc (product): 81153-100
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 81153-100-01 81153010001 1 BOTTLE in 1 CARTON (81153-100-01) / 10 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2025-07-01 No No Current