Benzhydrocodone and Acetaminophen

Product NDC: 10702-343
11-digit product format: 107020343
Labeler code: 10702
Product ID: 10702-343_c2b2ecba-e068-2abc-e053-2a95a90ae68c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Benzhydrocodone and Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: KVK-Tech, Inc.
Application: NDA208653
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2019-06-28
Marketing end: 0000-00-00
Substance: BENZHYDROCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength: 4 mg/1; mg/1
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	10702-343		D	Discontinued by firm		2026-08-17
excluded package	package	10702-343	10702-343-01	D	Discontinued by firm		2026-08-17

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 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10702-343-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10702-343-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10702-343-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10702-343-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10702-343-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10702-343-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10702-343-01	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10702-343-01	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10702-343-01	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10702-343-01	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10702-343-01	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10702-343-01	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10702-343-01	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10702-343-01	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10702-343-01	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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	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	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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
20ab58de-c64a-4ec2-9210-3aa3fae2b66f	Product name	1	20230808

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10702-343-01	2025-11-11	C162847	48780-1	1030e364-fc8f-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use BENZHYDROCODONE AND ACETAMINOPHEN TABLETS safely and effectively. See full prescribing information for BENZHYDROCODONE AND ACETAMINOPHEN TABLETS. BENZHYDROCODONE AND ACETAMINOPHEN tablets, for oral use, CII Initial U.S. Approval: 1982
10702-343-01	2024-01-30	C162847	48780-1	1030e364-fc8f-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use BENZHYDROCODONE AND ACETAMINOPHEN TABLETS safely and effectively. See full prescribing information for BENZHYDROCODONE AND ACETAMINOPHEN TABLETS. BENZHYDROCODONE AND ACETAMINOPHEN tablets, for oral use, CII Initial U.S. Approval: 1982

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10702-343-01	EA - Each	10702-343	28a0cb0d-5b3a-410d-8c13-9db3e04c389e	1	2019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10702-343	BENZHYDROCODONE AND ACETAMINOPHEN TABLET [KVK-TECH, INC.]	4	Legacy NDC	20210520_5e385b31-f3d4-4e30-a7d3-1461a838ed5f.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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
I894QAU7FJ	BENZHYDROCODONE HYDROCHLORIDE	1379679-42-1	BENZHYDROCODONE HYDROCHLORIDE
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10702-343-01	10702034301	100 TABLET in 1 BOTTLE, PLASTIC (10702-343-01)	100 tablet	2019-06-28	0000-00-00	No	No	Current