TRAMADOL HYDROCHLORIDE

Product NDC: 61919-597
11-digit product format: 619190597
Labeler code: 61919
Product ID: 61919-597_e9ab11b1-6c36-84f7-e053-2995a90aeb1f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TRAMADOL HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: DirectRX
Application: ANDA090404
Marketing category: ANDA
Marketing start: 2020-07-23
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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61919-597		I	Inactivated by FDA	2026-08-17
excluded package	package	61919-597	61919-597-20	I	Inactivated by FDA	2026-08-17
excluded package	package	61919-597	61919-597-30	I	Inactivated by FDA	2026-08-17
excluded package	package	61919-597	61919-597-40	I	Inactivated by FDA	2026-08-17
excluded package	package	61919-597	61919-597-60	I	Inactivated by FDA	2026-08-17
excluded package	package	61919-597	61919-597-72	I	Inactivated by FDA	2026-08-17
excluded package	package	61919-597	61919-597-82	I	Inactivated by FDA	2026-08-17
excluded package	package	61919-597	61919-597-84	I	Inactivated by FDA	2026-08-17
excluded package	package	61919-597	61919-597-90	I	Inactivated by FDA	2026-08-17

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 · 81 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	61919-597-72	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-597-90	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-597-20	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-597-60	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-597-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-597-82	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-597-40	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-597-84	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	61919-597-72	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-597-90	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-597-20	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-597-60	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-597-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-597-82	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-597-40	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-597-84	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	61919-597-72	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-597-90	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-597-20	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-597-60	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-597-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-597-82	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-597-40	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-597-84	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	61919-597-72	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-597-90	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-597-20	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-597-60	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-597-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-597-82	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-597-40	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-597-84	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	61919-597-72	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-597-90	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-597-20	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-597-60	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-597-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-597-82	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-597-40	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-597-84	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	61919-597-72	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-597-90	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-597-20	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-597-60	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-597-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-597-82	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-597-40	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-597-84	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	61919-597-60	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-597-30	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-597-90	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-597-20	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-597-40	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A090404-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2011-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090404-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090404-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-01-31	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090404-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090404-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090404-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090404-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090404-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090404-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090404-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090404-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090404-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090404-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090404-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090404-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090404-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090404-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090404-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090404-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090404-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090404-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090404-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090404-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090404-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090404-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090404-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090404-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090404-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090404-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090404-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090404-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090404-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090404-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090404-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090404-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090404-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090404-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090404-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090404-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090404-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090404-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090404-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090404-001	AB	1	`e64feba35796…`

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
61919-597-20	TRAMADOL HYDROCHLORIDE
61919-597-30	TRAMADOL HYDROCHLORIDE
61919-597-40	TRAMADOL HYDROCHLORIDE
61919-597-60	TRAMADOL HYDROCHLORIDE
61919-597-72	TRAMADOL HYDROCHLORIDE
61919-597-82	TRAMADOL HYDROCHLORIDE
61919-597-84	TRAMADOL HYDROCHLORIDE
61919-597-90	TRAMADOL HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-597-20	TRAMADOL HYDROCHLORIDE	20 in 1 BOTTLE	TABLET, FILM COATED	20	7
61919-597-30	TRAMADOL HYDROCHLORIDE	30 in 1 BOTTLE	TABLET, FILM COATED	30	7
61919-597-40	TRAMADOL HYDROCHLORIDE	40 in 1 BOTTLE	TABLET, FILM COATED	40	7
61919-597-60	TRAMADOL HYDROCHLORIDE	60 in 1 BOTTLE	TABLET, FILM COATED	60	7
61919-597-72	TRAMADOL HYDROCHLORIDE	120 in 1 BOTTLE	TABLET, FILM COATED	120	7
61919-597-82	TRAMADOL HYDROCHLORIDE	180 in 1 BOTTLE	TABLET, FILM COATED	180	7
61919-597-84	TRAMADOL HYDROCHLORIDE	240 in 1 BOTTLE	TABLET, FILM COATED	240	7
61919-597-90	TRAMADOL HYDROCHLORIDE	90 in 1 BOTTLE	TABLET, FILM COATED	90	7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]	1
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]	1
CELLULOSE ACETATE	INACTIVE INGREDIENT	3J2P07GVB6	TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-597	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]	7	Legacy NDC, 8 package rows	20230608_c34a95e3-d508-428f-9022-19cc5a90b4ec.zip

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
833709	traMADol HCl 100 MG 24HR Extended Release Oral Tablet	PSN	c34a95e3-d508-428f-9022-19cc5a90b4ec	7
835603	traMADol HCl 50 MG Oral Tablet	PSN	c34a95e3-d508-428f-9022-19cc5a90b4ec	7
833709	24 HR tramadol hydrochloride 100 MG Extended Release Oral Tablet	SCD	c34a95e3-d508-428f-9022-19cc5a90b4ec	7
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	c34a95e3-d508-428f-9022-19cc5a90b4ec	7
833709	tramadol hydrochloride 100 MG 24 HR Extended Release Oral Tablet	SY	c34a95e3-d508-428f-9022-19cc5a90b4ec	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-597-20	61919059720	20 TABLET, FILM COATED in 1 BOTTLE (61919-597-20)	2020-07-23	0000-00-00	No	No	Current
61919-597-30	61919059730	30 TABLET, FILM COATED in 1 BOTTLE (61919-597-30)	2020-07-23	0000-00-00	No	No	Current
61919-597-40	61919059740	40 TABLET, FILM COATED in 1 BOTTLE (61919-597-40)	2020-07-23	0000-00-00	No	No	Current
61919-597-60	61919059760	60 TABLET, FILM COATED in 1 BOTTLE (61919-597-60)	2020-07-23	0000-00-00	No	No	Current
61919-597-72	61919059772	120 TABLET, FILM COATED in 1 BOTTLE (61919-597-72)	2020-07-23	0000-00-00	No	No	Current
61919-597-82	61919059782	180 TABLET, FILM COATED in 1 BOTTLE (61919-597-82)	2020-07-23	0000-00-00	No	No	Current
61919-597-84	61919059784	240 TABLET, FILM COATED in 1 BOTTLE (61919-597-84)	2020-07-23	0000-00-00	No	No	Current
61919-597-90	61919059790	90 TABLET, FILM COATED in 1 BOTTLE (61919-597-90)	2020-07-23	0000-00-00	No	No	Current