Home NDC 50383-924 buprenorphine hydrochloride
Product NDC 50383-924
11-digit product format 503830924
Labeler code 50383
Product ID 50383-924_799a9357-de43-4a6c-91ac-cd3e6d99dec3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name buprenorphine hydrochloride
Dosage form TABLET
Route SUBLINGUAL
Labeler Akorn Operating Company LLC (dba Akorn)
Application ANDA090622
Marketing category ANDA
Marketing start 2010-09-24
Marketing end 0000-00-00
Substance BUPRENORPHINE HYDROCHLORIDE
Active strength 2 mg/1
Pharmacologic classes Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2023-12-31
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 · 4 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 50383-924-93 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 50383-924-93 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A090622-001 BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 A090622-002 BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24
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 3 · 84 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 2026-08-18 06:07:40 2026-07 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BUPRENORPHINE HYDROCHLORIDE ACTIVE INGREDIENT 56W8MW3EN1 BUPRENORPHINE HYDROCHLORIDE TABLET [HI-TECH PHARMACAL CO., INC.] 10 BUPRENORPHINE ACTIVE MOIETY 40D3SCR4GZ BUPRENORPHINE HYDROCHLORIDE TABLET [HI-TECH PHARMACAL CO., INC.] 10 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL BUPRENORPHINE HYDROCHLORIDE TABLET [HI-TECH PHARMACAL CO., INC.] 10 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X BUPRENORPHINE HYDROCHLORIDE TABLET [HI-TECH PHARMACAL CO., INC.] 10 MANNITOL INACTIVE INGREDIENT 3OWL53L36A BUPRENORPHINE HYDROCHLORIDE TABLET [HI-TECH PHARMACAL CO., INC.] 10 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X BUPRENORPHINE HYDROCHLORIDE TABLET [HI-TECH PHARMACAL CO., INC.] 10 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI BUPRENORPHINE HYDROCHLORIDE TABLET [HI-TECH PHARMACAL CO., INC.] 10 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ BUPRENORPHINE HYDROCHLORIDE TABLET [HI-TECH PHARMACAL CO., INC.] 10 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K BUPRENORPHINE HYDROCHLORIDE TABLET [HI-TECH PHARMACAL CO., INC.] 10
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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50383-924-93 50383092493 30 TABLET in 1 BOTTLE (50383-924-93) 30 tablet 2010-09-24 0000-00-00 No No Current