Home NDC 31722-254 Sugammadex
Product NDC 31722-254
11-digit product format 317220254
Labeler code 31722
Product ID 31722-254_530836fb-65b0-d1b5-e063-6394a90ac11c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sugammadex
Dosage form INJECTION
Route INTRAVENOUS
Labeler Camber Pharmaceuticals, Inc.
Application ANDA214337
Marketing category ANDA
Marketing start 2026-07-27
Substance SUGAMMADEX SODIUM
Active strength 100 mg/mL
Pharmacologic classes gamma-Cyclodextrins [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 31722-254-10 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 31722-254-10 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 31722-254-10 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 31722-254-10 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 31722-254-10 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 31722-254-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 31722-254-10 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 31722-254-10 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 31722-254-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 31722-254-10 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 31722-254-10 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 31722-254-10 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A214337-001 SUGAMMADEX SODIUM SUGAMMADEX SODIUM EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 A214337-002 SUGAMMADEX SODIUM SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09
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 2 · 46 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 2026-09-14 22:38:34 2026-08 A214337-001 SUGAMMADEX SODIUM EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214337-002 SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214337-001 SUGAMMADEX SODIUM EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214337-002 SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214337-001 SUGAMMADEX SODIUM EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214337-002 SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214337-001 SUGAMMADEX SODIUM EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214337-002 SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214337-001 SUGAMMADEX SODIUM EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214337-002 SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214337-001 SUGAMMADEX SODIUM EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214337-002 SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214337-001 SUGAMMADEX SODIUM EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214337-002 SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214337-001 SUGAMMADEX SODIUM EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214337-002 SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214337-001 SUGAMMADEX SODIUM EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214337-002 SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214337-001 SUGAMMADEX SODIUM EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214337-002 SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214337-001 SUGAMMADEX SODIUM EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214337-002 SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214337-001 SUGAMMADEX SODIUM EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214337-002 SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214337-001 SUGAMMADEX SODIUM EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214337-002 SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214337-001 SUGAMMADEX SODIUM EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214337-002 SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214337-001 SUGAMMADEX SODIUM EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214337-002 SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214337-001 SUGAMMADEX SODIUM EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A214337-002 SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214337-001 SUGAMMADEX SODIUM EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214337-002 SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214337-001 SUGAMMADEX SODIUM EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A214337-002 SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214337-001 SUGAMMADEX SODIUM EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A214337-002 SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214337-001 SUGAMMADEX SODIUM EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214337-002 SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-09 a72a2bbeb626…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 46 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Sugammadex
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SUGAMMADEX SODIUM 100 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ERJ6X2MXV7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1726992 Internal RxNorm lookup 1727000 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 31722-254-10 31722025410 10 VIAL, SINGLE-DOSE in 1 CARTON (31722-254-10) / 2 mL in 1 VIAL, SINGLE-DOSE 2026-07-27 No No Current