Tramadol Hydrochloride and Acetaminophen

Product NDC: 53217-040
11-digit product format: 532170040
Labeler code: 53217
Product ID: 53217-040_89d35016-9fee-46c7-8f7d-9168a2ad383a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tramadol Hydrochloride and Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA090485
Marketing category: ANDA
Marketing start: 2009-12-17
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]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53217-040		I	Inactivated by FDA	2026-08-11
excluded package	package	53217-040	53217-040-00	I	Inactivated by FDA	2026-08-11
excluded package	package	53217-040	53217-040-02	I	Inactivated by FDA	2026-08-11
excluded package	package	53217-040	53217-040-20	I	Inactivated by FDA	2026-08-11
excluded package	package	53217-040	53217-040-30	I	Inactivated by FDA	2026-08-11
excluded package	package	53217-040	53217-040-40	I	Inactivated by FDA	2026-08-11
excluded package	package	53217-040	53217-040-60	I	Inactivated by FDA	2026-08-11
excluded package	package	53217-040	53217-040-90	I	Inactivated by FDA	2026-08-11
excluded package	package	53217-040	53217-040-98	I	Inactivated by FDA	2026-08-11

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 4 · 189 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	53217-040-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53217-040-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53217-040-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53217-040-98	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53217-040-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53217-040-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53217-040-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53217-040-20	`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	53217-040-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53217-040-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53217-040-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53217-040-98	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53217-040-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53217-040-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53217-040-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53217-040-20	`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	53217-040-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53217-040-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53217-040-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53217-040-98	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53217-040-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53217-040-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53217-040-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53217-040-20	`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	53217-040-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53217-040-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53217-040-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53217-040-98	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53217-040-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53217-040-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53217-040-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53217-040-20	`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	53217-040-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53217-040-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53217-040-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53217-040-98	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53217-040-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53217-040-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53217-040-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53217-040-20	`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	53217-040-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53217-040-40	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53217-040-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53217-040-98	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53217-040-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53217-040-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53217-040-00	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53217-040-20	`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	53217-040-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53217-040-40	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53217-040-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53217-040-98	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53217-040-30	`302b2466d912…`	`e7b80fea0513…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A090485-001	AB

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090485-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090485-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090485-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090485-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090485-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090485-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090485-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090485-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090485-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090485-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090485-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090485-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090485-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090485-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090485-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090485-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090485-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090485-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090485-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090485-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090485-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090485-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090485-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090485-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090485-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090485-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090485-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090485-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090485-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090485-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090485-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090485-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090485-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090485-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090485-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090485-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090485-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090485-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090485-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090485-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
43d017e1-6ae6-7555-71d1-c249236d6f26	Product name	4	20251117
bff1fbab-f4cc-4993-b7de-2b555ee5eb73	Product name	1	20220509
c563c906-2606-457c-bb1b-5a623daed55b	Product name	1	20210511
43a9f8f9-34aa-8ae8-719e-5489454f7720	Product name	5	20200123
abd2f6f2-3fa7-4571-af8a-d67f89bdcb75	Product name	1	20190927
377068df-225f-7318-a910-a1987cdfa361	Product name	3	20170608
9457302e-0ca3-d9ff-0863-1b24b6107218	Product name	1	20140508
d5c49867-1fe9-7a44-3319-814417011d51	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
53217-040-00	Tramadol Hydrochloride and Acetaminophen Tablets, USP
53217-040-02	Tramadol Hydrochloride and Acetaminophen Tablets, USP
53217-040-20	Tramadol Hydrochloride and Acetaminophen Tablets, USP
53217-040-30	Tramadol Hydrochloride and Acetaminophen Tablets, USP
53217-040-40	Tramadol Hydrochloride and Acetaminophen Tablets, USP
53217-040-60	Tramadol Hydrochloride and Acetaminophen Tablets, USP
53217-040-90	Tramadol Hydrochloride and Acetaminophen Tablets, USP
53217-040-98	Tramadol Hydrochloride and Acetaminophen Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53217-040-00	Tramadol Hydrochloride and Acetaminophen	100 in 1 BOTTLE	TABLET	100	1
53217-040-02	Tramadol Hydrochloride and Acetaminophen	120 in 1 BOTTLE	TABLET	120	1
53217-040-20	Tramadol Hydrochloride and Acetaminophen	20 in 1 BOTTLE	TABLET	20	1
53217-040-30	Tramadol Hydrochloride and Acetaminophen	30 in 1 BOTTLE	TABLET	30	1
53217-040-40	Tramadol Hydrochloride and Acetaminophen	40 in 1 BOTTLE	TABLET	40	1
53217-040-60	Tramadol Hydrochloride and Acetaminophen	60 in 1 BOTTLE	TABLET	60	1
53217-040-90	Tramadol Hydrochloride and Acetaminophen	90 in 1 BOTTLE	TABLET	90	1
53217-040-98	Tramadol Hydrochloride and Acetaminophen	168 in 1 BOTTLE	TABLET	168	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53217-040-00	EA - Each	53217-040	cac3c18f-894e-4351-b570-1bf9621e0ead	1	2015-10-02
53217-040-02	EA - Each	53217-040	28f82279-854a-4184-b7bb-17c1c64ffceb	1	2015-10-02
53217-040-20	EA - Each	53217-040	04ad5c86-99a2-4440-ab5f-f217d0a00bbd	1	2015-10-02
53217-040-30	EA - Each	53217-040	a18957bf-5d85-4955-a77e-86ee1a84e7a8	1	2015-10-02
53217-040-40	EA - Each	53217-040	f19c3dd8-293e-4fa3-ab44-23d219fcbb28	1	2015-10-02
53217-040-60	EA - Each	53217-040	32f0bc12-7aab-40b9-9aed-4c6791c1a1ee	1	2015-10-02
53217-040-90	EA - Each	53217-040	1eb21cf4-223d-428e-919a-cb8d494469cc	1	2015-10-02
53217-040-98	EA - Each	53217-040	83d162ce-7518-4510-91da-d5fac0ed32c4	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53217-040	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 8 package rows	20141029_a1ddeea2-763e-4c37-a9f8-b57906c80a28.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tramadol/APAP	TRAMADOL/APAP	Direct_rx	4e40f55e-1d8e-ce2f-e063-6294a90a7bec	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090485 application number: ANDA090485
Tramadol Hydrochloride and Acetaminophen	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	AvPAK	244f6e5d-e1b4-ba8b-ca6f-af2d8a31d5f0	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090485 application number: ANDA090485
Tramadol Hydrochloride and Acetaminophen	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Amneal Pharmaceuticals of New York LLC	d51600e2-2f73-483c-9b2e-f142bafff16d	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090485 application number: ANDA090485
Tramadol Hydrochloride and Acetaminophen	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Preferred Pharmaceuticals Inc.	96094578-5348-4955-8e91-1c9163315d5a	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090485 application number: ANDA090485
Tramadol Hydrochloride and Acetaminophen	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Bryant Ranch Prepack	f33fcd05-2c95-48dd-884b-5ed9c25c2ccf	2024-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090485 application number: ANDA090485
Tramadol Hydrochloride and Acetaminophen	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Asclemed USA, Inc.	52693021-f60f-43bc-9b05-43db18621346	2022-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090485 application number: ANDA090485
Tramadol Hydrochloride and Acetaminophen	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Proficient Rx LP	1ad89537-3e59-438c-b646-b3c93b790853	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090485 application number: ANDA090485

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	a1ddeea2-763e-4c37-a9f8-b57906c80a28	1
836395	acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet	SCD	a1ddeea2-763e-4c37-a9f8-b57906c80a28	1
836395	APAP 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet	SY	a1ddeea2-763e-4c37-a9f8-b57906c80a28	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53217-040-00	53217004000	100 in 1 BOTTLE	Historical
53217-040-02	53217004002	120 in 1 BOTTLE	Historical
53217-040-20	53217004020	20 in 1 BOTTLE	Historical
53217-040-30	53217004030	30 in 1 BOTTLE	Historical
53217-040-40	53217004040	40 in 1 BOTTLE	Historical
53217-040-60	53217004060	60 in 1 BOTTLE	Historical
53217-040-90	53217004090	90 in 1 BOTTLE	Historical
53217-040-98	53217004098	168 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tramadol Hydrochloride and Acetaminophen Tablets, USP	Aidarex Pharmaceuticals LLC \| Aidarex Pharmaceuticals	2014-10-28	HUMAN PRESCRIPTION DRUG LABEL	1