Home NDC 42358-600 Abstral
Product NDC 42358-600
11-digit product format 423580600
Labeler code 42358
Product ID 42358-600_c6673375-386d-4fbe-ab79-1dd5c9a7c915
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fentanyl citrate
Dosage form TABLET, ORALLY DISINTEGRATING
Route SUBLINGUAL
Labeler Sentynl Therapeutics, Inc.
Application NDA022510
Marketing category NDA
Marketing start 2016-10-01
Marketing end 2020-06-30
Substance FENTANYL CITRATE
Active strength 600 ug/1
Pharmacologic classes Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 42358-600-32 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 42358-600-32 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 42358-600-32 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 42358-600-32 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 42358-600-32 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 42358-600-32 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 42358-600-32 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 42358-600-32 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 42358-600-32 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 42358-600-32 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 42358-600-32 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 42358-600-32 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022510-001 ABSTRAL FENTANYL CITRATE EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 N022510-002 ABSTRAL FENTANYL CITRATE EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 N022510-003 ABSTRAL FENTANYL CITRATE EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 N022510-004 ABSTRAL FENTANYL CITRATE EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 N022510-005 ABSTRAL FENTANYL CITRATE EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 N022510-006 ABSTRAL FENTANYL CITRATE EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07
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 7 · 264 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 2026-10-15 13:18:30 2026-09 N022510-001 ABSTRAL EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022510-002 ABSTRAL EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022510-003 ABSTRAL EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022510-004 ABSTRAL EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022510-005 ABSTRAL EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022510-006 ABSTRAL EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 c2088c7a36db…2026-09-14 22:38:34 2026-08 N022510-001 ABSTRAL EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022510-002 ABSTRAL EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022510-003 ABSTRAL EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022510-004 ABSTRAL EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022510-005 ABSTRAL EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022510-006 ABSTRAL EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022510-001 ABSTRAL EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022510-002 ABSTRAL EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022510-003 ABSTRAL EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022510-004 ABSTRAL EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022510-005 ABSTRAL EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022510-006 ABSTRAL EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022510-001 ABSTRAL EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022510-002 ABSTRAL EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022510-003 ABSTRAL EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022510-004 ABSTRAL EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022510-005 ABSTRAL EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022510-006 ABSTRAL EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022510-001 ABSTRAL EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022510-002 ABSTRAL EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022510-003 ABSTRAL EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022510-004 ABSTRAL EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022510-005 ABSTRAL EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022510-006 ABSTRAL EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022510-001 ABSTRAL EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022510-002 ABSTRAL EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022510-003 ABSTRAL EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022510-004 ABSTRAL EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022510-005 ABSTRAL EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022510-006 ABSTRAL EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022510-001 ABSTRAL EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022510-002 ABSTRAL EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022510-003 ABSTRAL EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022510-004 ABSTRAL EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2011-01-07 fd3edfee7708…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 2 · 72 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.