Home NDC 70040-0167 APADAZ
Product NDC 70040-0167
11-digit product format 700400167
Labeler code 70040
Product ID 70040-0167_29a56d99-ac58-69d0-e063-6394a90a32a0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Benzhydrocodone and Acetaminophen
Dosage form TABLET
Route ORAL
Labeler Zevra Therapeutics, Inc.
Application NDA208653
Marketing category NDA
Marketing start 2018-02-23
Substance ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE
Active strength 325; 6.12 mg/1; mg/1
DEA schedule CII
NDC exclude flag No
Listing certified through 2026-12-31
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 · 9 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 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 70040-0167-3 ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 70040-0167-1 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 70040-0167-3 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 70040-0167-1 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 70040-0167-3 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 70040-0167-1 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208653-001 APADAZ ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE 325MG;EQ 6.12MG BASE TABLET / ORAL RLD 2018-02-23 N208653-002 APADAZ ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE 325MG;EQ 4.08MG BASE TABLET / ORAL RLD 2019-01-04 N208653-003 APADAZ ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE 325MG;EQ 8.16MG BASE TABLET / ORAL RLD 2019-01-04
Orange Book patents# Current patent rows page 1 of 1 · 15 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208653-001 8748413 2030-07-01 Drug substance, Drug product 2018-03-22 N208653-001 8828978 2030-07-01 Drug product 2018-03-22 N208653-001 9132125 2030-07-01 U-2249 Drug substance, Drug product 2018-03-22 N208653-001 9549923 2030-07-01 Drug substance, Drug product 2018-03-22 N208653-001 8461137 2031-02-22 Drug substance, Drug product 2018-03-22 N208653-002 8748413 2030-07-01 Drug substance, Drug product 2019-01-25 N208653-002 8828978 2030-07-01 Drug product 2019-01-25 N208653-002 9132125 2030-07-01 U-2249 Drug substance, Drug product 2019-01-25 N208653-002 9549923 2030-07-01 Drug substance, Drug product 2019-01-25 N208653-002 8461137 2031-02-22 Drug substance, Drug product 2019-01-25 N208653-003 8748413 2030-07-01 Drug substance, Drug product 2019-01-25 N208653-003 8828978 2030-07-01 Drug product 2019-01-25 N208653-003 9132125 2030-07-01 U-2249 Drug substance, Drug product 2019-01-25 N208653-003 9549923 2030-07-01 Drug substance, Drug product 2019-01-25 N208653-003 8461137 2031-02-22 Drug substance, Drug product 2019-01-25
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.
Product history page 1 of 4 · 126 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 N208653-001 APADAZ 325MG;EQ 6.12MG BASE TABLET / ORAL RLD 2018-02-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208653-002 APADAZ 325MG;EQ 4.08MG BASE TABLET / ORAL RLD 2019-01-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208653-003 APADAZ 325MG;EQ 8.16MG BASE TABLET / ORAL RLD 2019-01-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208653-001 APADAZ 325MG;EQ 6.12MG BASE TABLET / ORAL RLD 2018-02-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208653-002 APADAZ 325MG;EQ 4.08MG BASE TABLET / ORAL RLD 2019-01-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208653-003 APADAZ 325MG;EQ 8.16MG BASE TABLET / ORAL RLD 2019-01-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208653-001 APADAZ 325MG;EQ 6.12MG BASE TABLET / ORAL RLD 2018-02-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208653-002 APADAZ 325MG;EQ 4.08MG BASE TABLET / ORAL RLD 2019-01-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208653-003 APADAZ 325MG;EQ 8.16MG BASE TABLET / ORAL RLD 2019-01-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208653-001 APADAZ 325MG;EQ 6.12MG BASE TABLET / ORAL RLD 2018-02-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208653-002 APADAZ 325MG;EQ 4.08MG BASE TABLET / ORAL RLD 2019-01-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208653-003 APADAZ 325MG;EQ 8.16MG BASE TABLET / ORAL RLD 2019-01-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208653-001 APADAZ 325MG;EQ 6.12MG BASE TABLET / ORAL RLD 2018-02-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208653-002 APADAZ 325MG;EQ 4.08MG BASE TABLET / ORAL RLD 2019-01-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208653-003 APADAZ 325MG;EQ 8.16MG BASE TABLET / ORAL RLD 2019-01-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208653-001 APADAZ 325MG;EQ 6.12MG BASE TABLET / ORAL RLD 2018-02-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208653-002 APADAZ 325MG;EQ 4.08MG BASE TABLET / ORAL RLD 2019-01-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208653-003 APADAZ 325MG;EQ 8.16MG BASE TABLET / ORAL RLD 2019-01-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208653-001 APADAZ 325MG;EQ 6.12MG BASE TABLET / ORAL RLD 2018-02-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208653-002 APADAZ 325MG;EQ 4.08MG BASE TABLET / ORAL RLD 2019-01-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208653-003 APADAZ 325MG;EQ 8.16MG BASE TABLET / ORAL RLD 2019-01-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208653-001 APADAZ 325MG;EQ 6.12MG BASE TABLET / ORAL RLD 2018-02-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208653-002 APADAZ 325MG;EQ 4.08MG BASE TABLET / ORAL RLD 2019-01-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208653-003 APADAZ 325MG;EQ 8.16MG BASE TABLET / ORAL RLD 2019-01-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208653-001 APADAZ 325MG;EQ 6.12MG BASE TABLET / ORAL RLD 2018-02-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208653-002 APADAZ 325MG;EQ 4.08MG BASE TABLET / ORAL RLD 2019-01-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208653-003 APADAZ 325MG;EQ 8.16MG BASE TABLET / ORAL RLD 2019-01-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208653-001 APADAZ 325MG;EQ 6.12MG BASE TABLET / ORAL RLD 2018-02-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208653-002 APADAZ 325MG;EQ 4.08MG BASE TABLET / ORAL RLD 2019-01-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208653-003 APADAZ 325MG;EQ 8.16MG BASE TABLET / ORAL RLD 2019-01-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208653-001 APADAZ 325MG;EQ 6.12MG BASE TABLET / ORAL RLD 2018-02-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208653-002 APADAZ 325MG;EQ 4.08MG BASE TABLET / ORAL RLD 2019-01-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208653-003 APADAZ 325MG;EQ 8.16MG BASE TABLET / ORAL RLD 2019-01-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208653-001 APADAZ 325MG;EQ 6.12MG BASE TABLET / ORAL RLD 2018-02-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208653-002 APADAZ 325MG;EQ 4.08MG BASE TABLET / ORAL RLD 2019-01-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208653-003 APADAZ 325MG;EQ 8.16MG BASE TABLET / ORAL RLD 2019-01-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208653-001 APADAZ 325MG;EQ 6.12MG BASE TABLET / ORAL RLD 2018-02-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208653-002 APADAZ 325MG;EQ 4.08MG BASE TABLET / ORAL RLD 2019-01-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208653-003 APADAZ 325MG;EQ 8.16MG BASE TABLET / ORAL RLD 2019-01-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208653-001 APADAZ 325MG;EQ 6.12MG BASE TABLET / ORAL RLD 2018-02-23 1e350fbaab3a…
Observed Orange Book patent history# Patent history page 1 of 16 · 630 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N208653-001 8748413 2030-07-01 Drug substance, Drug product 2018-03-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208653-001 8828978 2030-07-01 Drug product 2018-03-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208653-001 9132125 2030-07-01 U-2249 Drug substance, Drug product 2018-03-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208653-001 9549923 2030-07-01 Drug substance, Drug product 2018-03-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208653-001 8461137 2031-02-22 Drug substance, Drug product 2018-03-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208653-002 8748413 2030-07-01 Drug substance, Drug product 2019-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208653-002 8828978 2030-07-01 Drug product 2019-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208653-002 9132125 2030-07-01 U-2249 Drug substance, Drug product 2019-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208653-002 9549923 2030-07-01 Drug substance, Drug product 2019-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208653-002 8461137 2031-02-22 Drug substance, Drug product 2019-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208653-003 8748413 2030-07-01 Drug substance, Drug product 2019-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208653-003 8828978 2030-07-01 Drug product 2019-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208653-003 9132125 2030-07-01 U-2249 Drug substance, Drug product 2019-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208653-003 9549923 2030-07-01 Drug substance, Drug product 2019-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208653-003 8461137 2031-02-22 Drug substance, Drug product 2019-01-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208653-001 8748413 2030-07-01 Drug substance, Drug product 2018-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208653-001 8828978 2030-07-01 Drug product 2018-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208653-001 9132125 2030-07-01 U-2249 Drug substance, Drug product 2018-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208653-001 9549923 2030-07-01 Drug substance, Drug product 2018-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208653-001 8461137 2031-02-22 Drug substance, Drug product 2018-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208653-002 8748413 2030-07-01 Drug substance, Drug product 2019-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208653-002 8828978 2030-07-01 Drug product 2019-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208653-002 9132125 2030-07-01 U-2249 Drug substance, Drug product 2019-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208653-002 9549923 2030-07-01 Drug substance, Drug product 2019-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208653-002 8461137 2031-02-22 Drug substance, Drug product 2019-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208653-003 8748413 2030-07-01 Drug substance, Drug product 2019-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208653-003 8828978 2030-07-01 Drug product 2019-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208653-003 9132125 2030-07-01 U-2249 Drug substance, Drug product 2019-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208653-003 9549923 2030-07-01 Drug substance, Drug product 2019-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208653-003 8461137 2031-02-22 Drug substance, Drug product 2019-01-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208653-001 8748413 2030-07-01 Drug substance, Drug product 2018-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208653-001 8828978 2030-07-01 Drug product 2018-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208653-001 9132125 2030-07-01 U-2249 Drug substance, Drug product 2018-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208653-001 9549923 2030-07-01 Drug substance, Drug product 2018-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208653-001 8461137 2031-02-22 Drug substance, Drug product 2018-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208653-002 8748413 2030-07-01 Drug substance, Drug product 2019-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208653-002 8828978 2030-07-01 Drug product 2019-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208653-002 9132125 2030-07-01 U-2249 Drug substance, Drug product 2019-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208653-002 9549923 2030-07-01 Drug substance, Drug product 2019-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208653-002 8461137 2031-02-22 Drug substance, Drug product 2019-01-25 31067a03dcf5…
Additional Listing Data#
Finished product Yes
Brand name base APADAZ
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZHYDROCODONE HYDROCHLORIDE 6.12 mg/1 ACETAMINOPHEN 325 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination I894QAU7FJ Internal UNII lookup 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2001358 Internal RxNorm lookup 2001364 Internal RxNorm lookup 2118728 Internal RxNorm lookup 2118730 Internal RxNorm lookup 2118732 Internal RxNorm lookup 2118734 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 70040-0167-1 APADAZ 100 in 1 BOTTLE, PLASTIC TABLET 100 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70040-0167 APADAZ (BENZHYDROCODONE AND ACETAMINOPHEN) TABLET [ZEVRA THERAPEUTICS, INC.] 5 Current NDC, Legacy NDC, 1 package rows 20250108_0590d4e5-7107-4015-a6a8-deac14265aa2.zip
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 APADAZ BENZHYDROCODONE AND ACETAMINOPHEN Zevra Therapeutics, Inc. 0590d4e5-7107-4015-a6a8-deac14265aa2 2025-01-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 208653 application number: NDA208653 ndc (product): 70040-0167
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70040-0167-1 70040016701 100 TABLET in 1 BOTTLE, PLASTIC (70040-0167-1) 100 tablet 2018-02-23 No No Current