TRAMADOL HYDROCHLORIDE

Product NDC: 45865-976
11-digit product format: 458650976
Labeler code: 45865
Product ID: 45865-976_9af0e4c1-acb0-c57c-e053-2995a90ae1e8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TRAMADOL HYDROCHLORIDE
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: medsource pharmaceuticals
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: 2020-12-31
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	45865-976		I	Inactivated by FDA		2026-10-05
excluded package	package	45865-976	45865-976-30	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 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-976-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-976-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-976-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-976-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-976-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-976-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-976-30	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-976-30	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-976-30	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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

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 · 129 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	A200503-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2011-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200503-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200503-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200503-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2011-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200503-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200503-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A200503-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200503-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200503-003	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200503-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200503-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200503-003	AB1	1	`caaa826d4ba7…`
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…`

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
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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45865-976-30	2025-01-30	C162847	48780-1	2cef2736-7b6a-d83d-e063-dadaa90ab31f	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-976-30	TRAMADOL HYDROCHLORIDE	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-976	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]	1	Legacy NDC, 1 package rows	20191231_9af10904-99e3-8e81-e053-2a95a90a4be6.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 2 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	NuCare Pharmaceuticals,Inc.	93e129c8-64c4-1f6d-e053-2a95a90ac1f8	2024-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Medsource Pharmaceuticals	1278980b-4068-df57-e063-6394a90a8742	2024-02-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	3e0ccb95-3e8e-477c-b4d2-6060ee05f930	2023-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Asclemed USA, Inc.	a26ca887-e26c-4c32-8dbd-1fa2eb6db9dc	2023-02-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	0bff5535-0239-409e-8a2a-99d5ba38cca3	2022-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	3c187736-ea96-4e59-9fe6-cb625a619c63	2022-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	f63facd7-519b-4e2b-b54f-c17fc9ede55f	2022-03-01	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
833711	traMADol HCl 200 MG 24HR Extended Release Oral Tablet	PSN	9af10904-99e3-8e81-e053-2a95a90a4be6	1
833711	24 HR tramadol hydrochloride 200 MG Extended Release Oral Tablet	SCD	9af10904-99e3-8e81-e053-2a95a90a4be6	1
833711	tramadol HCl 200 MG 24 HR Extended Release Oral Tablet	SY	9af10904-99e3-8e81-e053-2a95a90a4be6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
45865-976-30	45865097630	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (45865-976-30)	2019-12-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TRAMADOL HYDROCHLORIDE	medsource pharmaceuticals \| LUPIN LIMITED	2019-12-30	HUMAN PRESCRIPTION DRUG LABEL	1