TRAMADOL HYDROCHLORIDE

Product NDC: 68071-5261
11-digit product format: 680715261
Labeler code: 68071
Product ID: 68071-5261_d7724981-3caf-cb8f-e053-2a95a90af84f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TRAMADOL HYDROCHLORIDE
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA200503
Marketing category: ANDA
Marketing start: 2014-08-19
Marketing end: 0000-00-00
Substance: TRAMADOL HYDROCHLORIDE
Active strength: 200 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2023-12-31
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	68071-5261		D	Discontinued by firm		2026-08-03
excluded package	package	68071-5261	68071-5261-3	D	Discontinued by firm		2026-08-03

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 · 22 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	68071-5261-3	`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	68071-5261-3	`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	68071-5261-3	`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	68071-5261-3	`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	68071-5261-3	`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	68071-5261-3	`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	68071-5261-3	`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	68071-5261-3	`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	68071-5261-3	`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	68071-5261-3	`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	68071-5261-3	`367a005e9d99…`	`383a685ebd0f…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A200503-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2011-08-29
A200503-002	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29
A200503-003	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A200503-001	AB1
A200503-002	AB1
A200503-003	AB1

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 · 123 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	A200503-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2011-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200503-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200503-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200503-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2011-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200503-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200503-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200503-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2011-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200503-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200503-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200503-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2011-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200503-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200503-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200503-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2011-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200503-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200503-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200503-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		RS	2011-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200503-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL			2011-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200503-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL			2011-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200503-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		RS	2011-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200503-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL			2011-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200503-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL			2011-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200503-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2011-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200503-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200503-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200503-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2011-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200503-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200503-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200503-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2011-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200503-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200503-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200503-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2011-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200503-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200503-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200503-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2011-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200503-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200503-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200503-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2011-08-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200503-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200503-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200503-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2011-08-29	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 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	A200503-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200503-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200503-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200503-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200503-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200503-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200503-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200503-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200503-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200503-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200503-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200503-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200503-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200503-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200503-003	AB1	1	`b8a1b40f171c…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200503-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200503-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200503-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200503-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200503-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200503-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200503-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200503-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200503-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200503-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200503-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200503-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200503-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200503-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200503-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200503-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200503-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200503-003	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200503-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200503-002	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200503-003	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200503-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200503-002	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200503-003	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200503-001	AB1	1	`5d02ea3f76ae…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-5261-3	2022-02-07	C162847	48780-1	d6a99b39-a7ae-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS. TRAMADOL hydrochloride extended-release tablets for oral use, C IV Initial U.S. Approval: 1995
68071-5261-3	2022-01-28	C162847	48780-1	d6a99b39-a7ae-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS. TRAMADOL hydrochloride extended-release tablets for oral use, C IV Initial U.S. Approval: 1995

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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	16053b28-c759-4914-93e6-2de0afe72445	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	6bb5be12-59ff-40f4-9841-9c7ab93be2ea	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	acd5d8e0-a4cc-4654-ae04-faff347a60ca	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	b76c1366-f6c0-42ad-bb19-2b72a91490e4	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	46bb9ae6-3ee8-463c-badb-c7a45a89b84b	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	83367367-5654-4078-831a-69ade48bc795	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	c30f6e9e-8014-40fc-9615-a6b8654137c1	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	A-S Medication Solutions	c28c98ac-7e07-46a5-8f34-57c008308fba	2025-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Coupler LLC	2f23ba6c-89d2-cc42-e063-6394a90aee0a	2025-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
Tramadol HCL ER	TRAMADOL HCL ER	Direct_Rx	09a7af47-423a-1e8b-e063-6394a90a99ef	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DIRECT RX	b3c702f7-0a8c-a52b-e053-2995a90a6df3	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
Tramadol HCL ER	TRAMADOL HCL	Advanced Rx Pharmacy of Tennessee, LLC	bf51a3af-cbc6-3021-e053-2a95a90a80b7	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
Tramadol HCL ER	TRAMADOL HCL	Advanced Rx Pharmacy of Tennessee, LLC	f8c5328d-7b47-626e-e053-6294a90a04b3	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Quality Care Products, LLC	68484531-f908-473f-a422-f37234de9691	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Quality Care Products, LLC	7e421fb6-737c-49b3-b299-50511e281a4d	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
Tramadol HCL ER	TRAMADOL HCL	Advanced Rx Pharmacy of Tennessee, LLC	b4cd4b64-7db5-da44-e053-2995a90a8953	2024-11-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HCL ER	TRAMADOL HCL	DIRECT RX	5285f056-c32c-4e7a-bec6-3a726aa23d5a	2024-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	8cc09b31-6067-44ec-8aba-ea7bb1a1f448	2024-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	b2f3f007-6dda-4532-9f7f-d93f6e65254c	2024-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	93c9c960-afbf-6d3d-e053-2995a90a8d15	2024-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503

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	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-5261-3	68071526103	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-5261-3)	2020-05-22	0000-00-00	No	No	Current