TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

Product NDC: 52959-814
11-digit product format: 529590814
Labeler code: 52959
Product ID: 52959-814_37302f24-ba1e-4146-b42c-549a8dd0e9e3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: ANDA077184
Marketing category: ANDA
Marketing start: 2005-12-16
Marketing end: 0000-00-00
Substance: TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN
Active strength: 38 mg/1; mg/1
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52959-814		I	Inactivated by FDA	2026-10-05
excluded package	package	52959-814	52959-814-12	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-814	52959-814-20	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-814	52959-814-30	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-814	52959-814-40	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-814	52959-814-60	I	Inactivated by FDA	2026-10-05

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 3 · 132 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	52959-814-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-814-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-814-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-814-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-814-20	`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	52959-814-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-814-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-814-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-814-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-814-20	`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	52959-814-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-814-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-814-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-814-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-814-20	`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	52959-814-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-814-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-814-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-814-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-814-20	`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	52959-814-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-814-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-814-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-814-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-814-20	`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	52959-814-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-814-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-814-40	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-814-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-814-20	`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	52959-814-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-814-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-814-40	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-814-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-814-20	`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	52959-814-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-814-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-814-40	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-814-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-814-20	`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	52959-814-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-814-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-814-40	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-814-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-814-20	`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	52959-814-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-814-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-814-40	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-814-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-814-20	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	325MG;37.5MG	TABLET / ORAL			2005-12-16

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-12-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-12-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2005-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2005-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2005-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2005-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2005-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2005-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2005-12-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2005-12-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2005-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2005-12-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2005-12-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2005-12-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2005-12-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2005-12-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2005-12-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2005-12-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2005-12-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2005-12-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2005-12-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2005-12-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2005-12-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2005-12-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2005-12-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2005-12-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2005-12-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2005-12-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2005-12-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077184-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2005-12-16	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077184-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077184-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077184-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077184-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077184-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077184-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077184-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077184-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077184-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077184-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077184-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077184-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077184-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077184-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077184-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077184-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077184-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077184-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077184-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077184-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077184-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077184-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077184-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077184-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077184-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077184-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077184-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077184-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077184-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077184-001	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
75d4bef7-334c-4a95-abb5-bff9def24114	Product name	2	20260112
43d017e1-6ae6-7555-71d1-c249236d6f26	Product name	4	20251117
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7f	Product name	5	20250115
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
88300afc-e1c4-ad17-c80b-4957f1b809a5	Product name	5	20250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043	Product name	7	20240611
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66f	Product name	1	20230808
a3631b20-02d1-41d7-8187-5e5e850b9e80	Product name	1	20230306
79e1734e-f721-4d46-978a-be382f771672	Product name	2	20230110
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
bff1fbab-f4cc-4993-b7de-2b555ee5eb73	Product name	1	20220509
92ead9ae-674d-4eee-a492-c385d496891f	Product name	3	20220308
c563c906-2606-457c-bb1b-5a623daed55b	Product name	1	20210511
103b151b-b17f-42ac-8624-3ef62f5e2975	Product name	2	20200507
b8497372-efe9-9dde-fa2d-59be9761aa64	Product name	9	20200428
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
43a9f8f9-34aa-8ae8-719e-5489454f7720	Product name	5	20200123
abd2f6f2-3fa7-4571-af8a-d67f89bdcb75	Product name	1	20190927
3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880	Product name	1	20190320
00d531e4-b130-8c52-eaf9-826cbb6f15dd	Product name	3	20190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659	Product name	9	20190205
22d922aa-c443-d9f3-b23c-03b03a9ad31c	Product name	7	20181220
377068df-225f-7318-a910-a1987cdfa361	Product name	3	20170608
23475c0b-a5b5-4fec-b97f-acca901eae6a	Product name	1	20140718
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
3ed6b849-48b8-8899-c288-6eeb396123b6	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
9457302e-0ca3-d9ff-0863-1b24b6107218	Product name	1	20140508
96c5169b-5b9d-547d-bf22-d688d91866e4	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
c8753a88-edde-8e17-a396-705537b52cee	Product name	1	20140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ce	Product name	1	20140508
cf3a804d-0326-aa22-0142-c184b5657d85	Product name	1	20140508
d5c49867-1fe9-7a44-3319-814417011d51	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
52959-814-12	Rx only
52959-814-20	Rx only
52959-814-30	Rx only
52959-814-40	Rx only
52959-814-60	Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52959-814-12	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	12 in 1 VIAL	TABLET, FILM COATED	12	2
52959-814-20	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	20 in 1 VIAL	TABLET, FILM COATED	20	2
52959-814-30	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	30 in 1 VIAL	TABLET, FILM COATED	30	2
52959-814-40	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	40 in 1 VIAL	TABLET, FILM COATED	40	2
52959-814-60	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	60 in 1 VIAL	TABLET, FILM COATED	60	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-814-12	EA - Each	52959-814	2980f570-ecd2-4f71-a789-b78ec8c2668c	1	2012-07-24
52959-814-20	EA - Each	52959-814	dd6a306f-73f7-4c49-85be-4ca2b20f4283	1	2012-07-24
52959-814-30	EA - Each	52959-814	efb80c96-3628-44f0-9a8b-5bd8b58063d8	1	2012-07-24
52959-814-40	EA - Each	52959-814	3bf95a27-9b1a-4bce-95bf-88e28473adbe	1	2012-07-24
52959-814-60	EA - Each	52959-814	cc45b3a4-ac7c-4e46-941d-71982d8e054a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-814	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2	Legacy NDC, 5 package rows	20120425_45190f26-d4cc-4cac-86b4-f79ea3b88fa2.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9N7R477WCK	TRAMADOL HYDROCHLORIDE	36282-47-0	TRAMADOL HYDROCHLORIDE
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
836395	traMADol HCl 37.5 MG / acetaminophen 325 MG Oral Tablet	PSN	45190f26-d4cc-4cac-86b4-f79ea3b88fa2	2
836395	acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet	SCD	45190f26-d4cc-4cac-86b4-f79ea3b88fa2	2
836395	APAP 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet	SY	45190f26-d4cc-4cac-86b4-f79ea3b88fa2	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-814-12	52959081412	12 in 1 VIAL	Historical
52959-814-20	52959081420	20 in 1 VIAL	Historical
52959-814-30	52959081430	30 in 1 VIAL	Historical
52959-814-40	52959081440	40 in 1 VIAL	Historical
52959-814-60	52959081460	60 in 1 VIAL	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rx only	H.J. Harkins Company, Inc. \| Sun Pharmaceutical Industries, Ltd.	2012-04-19	Human Prescription Drug Label	2