TRAMADOL HYDROCHLORIDE

Product NDC: 61919-073
11-digit product format: 619190073
Labeler code: 61919
Product ID: 61919-073_d554a939-5fac-2c91-e053-2a95a90a36c2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TRAMADOL HYDROCHLORIDE
Dosage form: TABLET, COATED
Route: ORAL
Labeler: DIRECT RX
Application: ANDA076003
Marketing category: ANDA
Marketing start: 2018-06-15
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 · 13 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61919-073		I	Inactivated by FDA	2026-08-03
excluded product	product	61919-073		I	Inactivated by FDA	2026-08-03
excluded product	product	61919-073		I	Inactivated by FDA	2026-08-03
excluded package	package	61919-073	61919-073-21	I	Inactivated by FDA	2026-08-03
excluded package	package	61919-073	61919-073-40	I	Inactivated by FDA	2026-08-03
excluded package	package	61919-073	61919-073-20	I	Inactivated by FDA	2026-08-03
excluded package	package	61919-073	61919-073-30	I	Inactivated by FDA	2026-08-03
excluded package	package	61919-073	61919-073-60	I	Inactivated by FDA	2026-08-03
excluded package	package	61919-073	61919-073-71	I	Inactivated by FDA	2026-08-03
excluded package	package	61919-073	61919-073-72	I	Inactivated by FDA	2026-08-03
excluded package	package	61919-073	61919-073-82	I	Inactivated by FDA	2026-08-03
excluded package	package	61919-073	61919-073-84	I	Inactivated by FDA	2026-08-03
excluded package	package	61919-073	61919-073-90	I	Inactivated by FDA	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 4 · 236 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 product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-073-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-073-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-073-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-073-84	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-073-72	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-073-82	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-073-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-073-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-073-71	`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 product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-073-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-073-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-073-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-073-84	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-073-72	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-073-82	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-073-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-073-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-073-71	`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 product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-073-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-073-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-073-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-073-84	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-073-72	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-073-82	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-073-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-073-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-073-71	`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 product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-073-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-073-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-073-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-073-84	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-073-72	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-073-82	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-073-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-073-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-073-71	`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 product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-073-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-073-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-073-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-073-84	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-073-72	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-073-82	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-073-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-073-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-073-71	`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 product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-073-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-073-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-073-40	`cdf11ea48f46…`	`ba0047e9e063…`

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
A076003-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076003-001	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	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`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	A076003-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076003-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076003-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076003-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076003-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076003-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076003-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076003-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076003-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076003-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076003-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076003-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076003-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076003-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076003-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076003-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076003-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076003-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076003-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076003-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076003-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076003-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076003-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076003-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076003-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076003-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076003-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076003-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076003-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076003-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076003-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076003-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076003-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076003-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076003-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076003-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076003-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076003-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076003-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076003-001	AB	1	`cb3db0bc1861…`

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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
d5c49867-1fe9-7a44-3319-814417011d51	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
61919-073-40	2021-01-29	ba0f9c33-314a-a910-e053-dadaa90a0b85	TRAMADOL HYDROCHLORIDE
61919-073-20	2020-01-31	9d75b9d0-ff04-f424-e053-dadaa90a57ce	TRAMADOL HYDROCHLORIDE
61919-073-30	2020-01-31	9d75b9d0-ff04-f424-e053-dadaa90a57ce	TRAMADOL HYDROCHLORIDE
61919-073-60	2020-01-31	9d75b9d0-ff04-f424-e053-dadaa90a57ce	TRAMADOL HYDROCHLORIDE
61919-073-71	2020-01-31	9d75b9d0-ff04-f424-e053-dadaa90a57ce	TRAMADOL HYDROCHLORIDE
61919-073-72	2020-01-31	9d75b9d0-ff04-f424-e053-dadaa90a57ce	TRAMADOL HYDROCHLORIDE
61919-073-82	2020-01-31	9d75b9d0-ff04-f424-e053-dadaa90a57ce	TRAMADOL HYDROCHLORIDE
61919-073-84	2020-01-31	9d75b9d0-ff04-f424-e053-dadaa90a57ce	TRAMADOL HYDROCHLORIDE
61919-073-90	2020-01-31	9d75b9d0-ff04-f424-e053-dadaa90a57ce	TRAMADOL HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-073-21	TRAMADOL HYDROCHLORIDE	21 in 1 BOTTLE	TABLET, COATED	21	18
61919-073-20	TRAMADOL HYDROCHLORIDE	20 in 1 BOTTLE	TABLET, COATED	20	3
61919-073-30	TRAMADOL HYDROCHLORIDE	30 in 1 BOTTLE	TABLET, COATED	30	3
61919-073-60	TRAMADOL HYDROCHLORIDE	60 in 1 BOTTLE	TABLET, COATED	60	3
61919-073-71	TRAMADOL HYDROCHLORIDE	100 in 1 BOTTLE	TABLET, COATED	100	3
61919-073-72	TRAMADOL HYDROCHLORIDE	120 in 1 BOTTLE	TABLET, COATED	120	3
61919-073-82	TRAMADOL HYDROCHLORIDE	180 in 1 BOTTLE	TABLET, COATED	180	3
61919-073-84	TRAMADOL HYDROCHLORIDE	240 in 1 BOTTLE	TABLET, COATED	240	3
61919-073-90	TRAMADOL HYDROCHLORIDE	90 in 1 BOTTLE	TABLET, COATED	90	3
61919-073-40	TRAMADOL HYDROCHLORIDE	40 in 1 BOTTLE	TABLET, COATED	40	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-073-30	EA - Each	61919-073	80541ac2-ce67-4b7c-885b-fefc77582e32	1	2015-02-02
61919-073-60	EA - Each	61919-073	e268a13d-7d24-4fb2-89db-a59a49e0bec0	1	2015-02-02
61919-073-82	EA - Each	61919-073	f7427129-5bff-410d-8af8-d3295a43ec00	1	2015-11-12
61919-073-84	EA - Each	61919-073	d32c51fa-0d87-4517-a1f0-993d49920790	1	2015-02-02
61919-073-90	EA - Each	61919-073	bf2b9bdc-1694-4e8d-bc06-e867ce6dc499	1	2015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]	3
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	TRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]	3
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]	1
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]	1
CELLULOSE ACETATE	INACTIVE INGREDIENT	3J2P07GVB6	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-073	TRAMADOL HCL ER (TRAMADOL HCL) TABLET, EXTENDED RELEASE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE TRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]	18	Legacy NDC, 1 package rows	20241019_5285f056-c32c-4e7a-bec6-3a726aa23d5a.zip
61919-073	TRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]	3	Legacy NDC, 8 package rows	20151103_4a17d714-9151-4e20-bfab-3deddbf8e04f.zip
61919-073	TRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT_RX]	1	Legacy NDC, 1 package rows	20190710_8d40dce1-8394-d4a7-e053-2995a90a480a.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Coupler LLC	54d74939-301b-e603-e063-6394a90a3b03	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Major Pharmaceuticals	6b0b95b2-ae4c-42e8-9f2e-bcdaffda62e2	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	67919c2c-2f8a-4bbb-bef5-0cd6c1e63a16	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	8ec4e4e5-a56e-4198-8428-6b770b9bf27d	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	American Health Packaging	f6f6069b-cc75-4b87-afa5-b83001b543e0	2025-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	2e738ced-9cde-e776-e063-6294a90a7e33	2025-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Clinical Solutions Wholesale, LLC	728157e2-d153-4ea0-81eb-36599dc7dfda	2025-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	5babcfcf-331b-5db9-e053-2a91aa0aaf89	2025-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol HCL	TRAMADOL HCL	Advanced Rx of Tennessee, LLC	af87fc31-07c2-b1f7-e053-2995a90a499f	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
TRAMADOL HCL ER	TRAMADOL HCL	DIRECT RX	5285f056-c32c-4e7a-bec6-3a726aa23d5a	2024-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 61919-073
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Amneal Pharmaceuticals LLC	58b802cb-2443-4f5b-9718-7d54c6d50cb4	2021-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	50f4b752-20af-4ebf-9408-e78f30d2a3cc	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003

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	5285f056-c32c-4e7a-bec6-3a726aa23d5a	18
833711	traMADol HCl 200 MG 24HR Extended Release Oral Tablet	PSN	5285f056-c32c-4e7a-bec6-3a726aa23d5a	18
835603	traMADol HCl 50 MG Oral Tablet	PSN	5285f056-c32c-4e7a-bec6-3a726aa23d5a	18
833709	24 HR tramadol hydrochloride 100 MG Extended Release Oral Tablet	SCD	5285f056-c32c-4e7a-bec6-3a726aa23d5a	18
833711	24 HR tramadol hydrochloride 200 MG Extended Release Oral Tablet	SCD	5285f056-c32c-4e7a-bec6-3a726aa23d5a	18
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	5285f056-c32c-4e7a-bec6-3a726aa23d5a	18
833711	tramadol HCl 200 MG 24 HR Extended Release Oral Tablet	SY	5285f056-c32c-4e7a-bec6-3a726aa23d5a	18
833709	tramadol hydrochloride 100 MG 24 HR Extended Release Oral Tablet	SY	5285f056-c32c-4e7a-bec6-3a726aa23d5a	18
835603	traMADol HCl 50 MG Oral Tablet	PSN	4a17d714-9151-4e20-bfab-3deddbf8e04f	3
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	4a17d714-9151-4e20-bfab-3deddbf8e04f	3
835603	traMADol HCl 50 MG Oral Tablet	PSN	8d40dce1-8394-d4a7-e053-2995a90a480a	1
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	8d40dce1-8394-d4a7-e053-2995a90a480a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-073-20	61919007320	20 in 1 BOTTLE					Historical
61919-073-21	61919007321	21 TABLET, COATED in 1 BOTTLE (61919-073-21)	2018-06-15	0000-00-00	No	No	Current
61919-073-30	61919007330	30 in 1 BOTTLE					Historical
61919-073-40	61919007340	40 in 1 BOTTLE					Historical
61919-073-60	61919007360	60 in 1 BOTTLE					Historical
61919-073-71	61919007371	100 in 1 BOTTLE					Historical
61919-073-72	61919007372	120 in 1 BOTTLE					Historical
61919-073-82	61919007382	180 in 1 BOTTLE					Historical
61919-073-84	61919007384	240 in 1 BOTTLE					Historical
61919-073-90	61919007390	90 in 1 BOTTLE					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TRAMADOL HYDROCHLORIDE	DIRECT RX	2024-10-17	HUMAN PRESCRIPTION DRUG LABEL	18
TRAMADOL HYDROCHLORIDE	Direct_Rx	2019-07-09	HUMAN PRESCRIPTION DRUG LABEL	1
TRAMADOL HYDROCHLORIDE	DIRECT RX	2015-11-02	HUMAN PRESCRIPTION DRUG LABEL	3