Tramadol Hydrochloride

Product NDC: 70518-3586
11-digit product format: 705183586
Labeler code: 70518
Product ID: 70518-3586_ef1a50cb-a1a3-2602-e053-2a95a90a0e4a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tramadol Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA203494
Marketing category: ANDA
Marketing start: 2022-12-05
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: 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70518-3586		D	Discontinued by firm	2026-08-03
excluded package	package	70518-3586	70518-3586-0	D	Discontinued by firm	2026-08-03
excluded package	package	70518-3586	70518-3586-1	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 · 12 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	70518-3586-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-3586-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-3586-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-3586-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-3586-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-3586-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-3586-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-3586-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-3586-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-3586-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-3586-0	`ad56d346431e…`	`cc804d4bbf1e…`

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
A203494-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2014-03-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203494-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`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	A203494-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203494-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203494-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203494-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203494-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203494-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203494-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203494-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203494-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203494-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203494-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203494-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203494-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203494-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203494-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203494-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203494-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203494-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203494-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203494-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203494-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203494-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203494-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203494-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203494-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203494-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203494-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203494-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203494-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203494-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203494-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203494-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203494-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203494-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203494-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203494-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203494-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203494-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203494-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203494-001	AB	1	`cb3db0bc1861…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3586	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.]	8	Legacy NDC	20241011_417959a7-8560-4949-a34a-4a269c83f932.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	f2f421ab-35ae-7637-e053-2995a90a40e0	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203494 application number: ANDA203494
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Rising Pharma Holdings, Inc.	a63eadda-cabb-4f2c-86f9-2d8b4a2c88f3	2026-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203494 application number: ANDA203494
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Aurobindo Pharma Limited	e5005d9e-91cb-4ff8-bcf2-b5ee70cf4f3f	2025-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203494 application number: ANDA203494
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	e90d4ef3-8b90-41b7-bf96-340852e89b5f	2024-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203494 application number: ANDA203494

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
70518-3586-0	70518358600	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3586-0)	2022-12-05	0000-00-00	No	No	Current