tramadol hydrochloride

Product NDC: 70934-461
11-digit product format: 709340461
Labeler code: 70934
Product ID: 70934-461_aefaa655-aa3a-015e-e053-2a95a90a80d5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tramadol hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Denton Pharma, Inc. dba Northwind Pharmaceuticals
Application: ANDA075964
Marketing category: ANDA
Marketing start: 2019-10-31
Marketing end: 0000-00-00
Substance: TRAMADOL HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70934-461		D	Discontinued by firm	2026-10-12
excluded package	package	70934-461	70934-461-20	D	Discontinued by firm	2026-10-12
excluded package	package	70934-461	70934-461-30	D	Discontinued by firm	2026-10-12
excluded package	package	70934-461	70934-461-60	D	Discontinued by firm	2026-10-12
excluded package	package	70934-461	70934-461-90	D	Discontinued by firm	2026-10-12

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 2 · 69 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	70934-461-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70934-461-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70934-461-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70934-461-30	`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	70934-461-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70934-461-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70934-461-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70934-461-30	`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	70934-461-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70934-461-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70934-461-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70934-461-30	`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	70934-461-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70934-461-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70934-461-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70934-461-30	`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	70934-461-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70934-461-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70934-461-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70934-461-30	`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	70934-461-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70934-461-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70934-461-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70934-461-30	`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	70934-461-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70934-461-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70934-461-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70934-461-30	`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	70934-461-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70934-461-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70934-461-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70934-461-30	`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	70934-461-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70934-461-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70934-461-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70934-461-30	`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	70934-461-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70934-461-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70934-461-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70934-461-30	`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	70934-461-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70934-461-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70934-461-20	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70934-461-30	`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	70934-461-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70934-461-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70934-461-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70934-461-30	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A075964-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075964-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A075964-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075964-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075964-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
70934-461-20	2023-02-08	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
70934-461-90	2023-02-08	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
70934-461-20	2022-01-28	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
70934-461-90	2022-01-28	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9N7R477WCK	TRAMADOL HYDROCHLORIDE	36282-47-0	TRAMADOL HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70934-461-20	70934046120	20 TABLET in 1 BOTTLE, PLASTIC (70934-461-20)	20 tablet	2019-10-31	0000-00-00	No	No	Current
70934-461-90	70934046190	90 TABLET in 1 BOTTLE, PLASTIC (70934-461-90)	90 tablet	2020-10-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
tramadol hydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	3