TRAMADOL HYDROCHLORIDE

Product NDC: 52959-688
11-digit product format: 529590688
Labeler code: 52959
Product ID: 52959-688_5d544cbc-94c2-6194-e053-2991aa0ada36
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TRAMADOL HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: H.J. Harkins Company Inc.
Application: ANDA090404
Marketing category: ANDA
Marketing start: 2017-01-03
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: 2019-12-31
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	52959-688		I	Inactivated by FDA	2026-08-17
excluded package	package	52959-688	52959-688-00	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-688	52959-688-02	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-688	52959-688-10	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-688	52959-688-15	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-688	52959-688-20	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-688	52959-688-21	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-688	52959-688-28	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-688	52959-688-30	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-688	52959-688-40	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-688	52959-688-50	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-688	52959-688-60	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-688	52959-688-90	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 5 · 273 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	52959-688-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-688-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-688-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-688-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-688-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-688-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-688-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-688-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-688-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-688-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-688-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-688-90	`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	52959-688-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-688-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-688-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-688-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-688-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-688-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-688-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-688-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-688-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-688-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-688-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-688-90	`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	52959-688-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-688-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-688-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-688-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-688-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-688-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-688-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-688-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-688-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-688-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-688-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-688-90	`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	52959-688-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-688-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-688-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-688-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-688-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-688-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-688-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-688-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-688-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-688-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-688-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-688-90	`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	52959-688-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-688-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-688-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-688-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-688-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-688-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-688-28	`cfe11265f3b6…`	`090c488252e2…`

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
52959-688-00	5d544cbc-94c1-6194-e053-2991aa0ada36
52959-688-02	5d544cbc-94c1-6194-e053-2991aa0ada36
52959-688-10	5d544cbc-94c1-6194-e053-2991aa0ada36
52959-688-15	5d544cbc-94c1-6194-e053-2991aa0ada36
52959-688-20	5d544cbc-94c1-6194-e053-2991aa0ada36
52959-688-21	5d544cbc-94c1-6194-e053-2991aa0ada36
52959-688-28	5d544cbc-94c1-6194-e053-2991aa0ada36
52959-688-30	5d544cbc-94c1-6194-e053-2991aa0ada36
52959-688-40	5d544cbc-94c1-6194-e053-2991aa0ada36
52959-688-50	5d544cbc-94c1-6194-e053-2991aa0ada36
52959-688-60	5d544cbc-94c1-6194-e053-2991aa0ada36
52959-688-90	5d544cbc-94c1-6194-e053-2991aa0ada36

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52959-688-60	Theratramadol-90	60 in 1 BOTTLE	TABLET	60	50 mg	22
52959-688-60	Theratramadol-60	60 in 1 BOTTLE	TABLET	60	50 mg	3
52959-688-00	TRAMADOL HYDROCHLORIDE	100 in 1 CONTAINER	TABLET	100		1
52959-688-02	TRAMADOL HYDROCHLORIDE	120 in 1 CONTAINER	TABLET	120		1
52959-688-10	TRAMADOL HYDROCHLORIDE	10 in 1 CONTAINER	TABLET	10		1
52959-688-15	TRAMADOL HYDROCHLORIDE	15 in 1 CONTAINER	TABLET	15		1
52959-688-20	TRAMADOL HYDROCHLORIDE	20 in 1 CONTAINER	TABLET	20		1
52959-688-21	TRAMADOL HYDROCHLORIDE	21 in 1 CONTAINER	TABLET	21		1
52959-688-28	TRAMADOL HYDROCHLORIDE	28 in 1 CONTAINER	TABLET	28		1
52959-688-30	TRAMADOL HYDROCHLORIDE	30 in 1 CONTAINER	TABLET	30		1
52959-688-40	TRAMADOL HYDROCHLORIDE	40 in 1 CONTAINER	TABLET	40		1
52959-688-50	TRAMADOL HYDROCHLORIDE	50 in 1 CONTAINER	TABLET	50		1
52959-688-60	TRAMADOL HYDROCHLORIDE	60 in 1 BOTTLE	TABLET	60		1
52959-688-90	TRAMADOL HYDROCHLORIDE	90 in 1 CONTAINER	TABLET	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-688-00	EA - Each	52959-688	7c01630c-13d5-4e4a-a868-7bf91f83fbd4	1	2017-12-14
52959-688-02	EA - Each	52959-688	80921bf3-a3c6-493e-b203-ecfe5fe88504	1	2017-12-14
52959-688-10	EA - Each	52959-688	0cb8c36d-73e4-45db-96bf-c972eab58785	1	2017-12-14
52959-688-15	EA - Each	52959-688	10aa5eed-0de7-41df-b73e-9c7941139d3d	1	2017-12-14
52959-688-20	EA - Each	52959-688	e868d378-9a08-4835-94df-f5671af1bcf5	1	2017-12-14
52959-688-21	EA - Each	52959-688	6a3421b1-62fb-476b-9100-4a43210bc546	1	2017-12-14
52959-688-28	EA - Each	52959-688	c8167055-5aa9-4abe-a1d9-2503820e1d3b	1	2017-12-14
52959-688-30	EA - Each	52959-688	10cbd269-eb45-4785-8ee3-7c11cce8648f	1	2017-12-14
52959-688-40	EA - Each	52959-688	8e07888c-86d5-48cd-bffb-01ef9c025ea0	1	2017-12-14
52959-688-50	EA - Each	52959-688	f105f142-7552-4616-bdef-2ee53620613c	1	2017-12-14
52959-688-60	EA - Each	52959-688	5dbefb3c-a8df-4025-b6e3-7d9243cff783	1	2017-12-14
52959-688-90	EA - Each	52959-688	0262d035-5b69-4be8-a0c6-924c5d55ff73	1	2017-12-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
.GAMMA.-AMINOBUTYRIC ACID	ACTIVE INGREDIENT	2ACZ6IPC6I	THERATRAMADOL-90 (TRAMADOL HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	22
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	THERATRAMADOL-90 (TRAMADOL HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	22
.GAMMA.-AMINOBUTYRIC ACID	ACTIVE MOIETY	2ACZ6IPC6I	THERATRAMADOL-90 (TRAMADOL HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	22
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	THERATRAMADOL-90 (TRAMADOL HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	22
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	THERATRAMADOL-90 (TRAMADOL HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	22
GELATIN	INACTIVE INGREDIENT	2G86QN327L	THERATRAMADOL-90 (TRAMADOL HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	22
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	THERATRAMADOL-90 (TRAMADOL HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	22
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	THERATRAMADOL-90 (TRAMADOL HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	22
.GAMMA.-AMINOBUTYRIC ACID	ACTIVE INGREDIENT	2ACZ6IPC6I	THERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]	3
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	THERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]	3
.GAMMA.-AMINOBUTYRIC ACID	ACTIVE MOIETY	2ACZ6IPC6I	THERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]	3
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	THERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	THERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]	3
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	THERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	THERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	THERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]	3
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	THERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	THERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	THERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]	3
TRICALCIUM PHOSPHATE	INACTIVE INGREDIENT	K4C08XP666	THERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-688	THERATRAMADOL-90 (TRAMADOL HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	22	Legacy NDC	20110812_b4a17a69-e764-456c-8aa9-d31221c86a6b.zip
52959-688	THERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]	3	Legacy NDC	20110812_379f8193-c371-4ae9-a272-43c5b9b18349.zip
52959-688	TRAMADOL HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY INC.]	1	Legacy NDC, 12 package rows	20171110_5d544cbc-94c1-6194-e053-2991aa0ada36.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
835603	traMADol HCl 50 MG Oral Tablet	PSN	b4a17a69-e764-456c-8aa9-d31221c86a6b	22
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	b4a17a69-e764-456c-8aa9-d31221c86a6b	22
835603	traMADol HCl 50 MG Oral Tablet	PSN	379f8193-c371-4ae9-a272-43c5b9b18349	3
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	379f8193-c371-4ae9-a272-43c5b9b18349	3
835603	traMADol HCl 50 MG Oral Tablet	PSN	5d544cbc-94c1-6194-e053-2991aa0ada36	1
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	5d544cbc-94c1-6194-e053-2991aa0ada36	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-688-00	52959068800	100 in 1 CONTAINER	Historical
52959-688-02	52959068802	120 in 1 CONTAINER	Historical
52959-688-10	52959068810	10 in 1 CONTAINER	Historical
52959-688-15	52959068815	15 in 1 CONTAINER	Historical
52959-688-20	52959068820	20 in 1 CONTAINER	Historical
52959-688-21	52959068821	21 in 1 CONTAINER	Historical
52959-688-28	52959068828	28 in 1 CONTAINER	Historical
52959-688-30	52959068830	30 in 1 CONTAINER	Historical
52959-688-40	52959068840	40 in 1 CONTAINER	Historical
52959-688-50	52959068850	50 in 1 CONTAINER	Historical
52959-688-60	52959068860	60 in 1 BOTTLE	Historical
52959-688-90	52959068890	90 in 1 CONTAINER	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TRAMADOL HYDROCHLORIDE - H.J. Harkins Company Inc. \| H. J. Harkins Company Inc.	H.J. Harkins Company Inc. \| H. J. Harkins Company Inc.	2017-11-06	HUMAN PRESCRIPTION DRUG LABEL	1
Theratramadol-90	Physician Therapeutics LLC \| Ameal Pharmaceuticals \| H.J. Harkins Company, Inc. \| Targeted Medical Pharma Inc.	2011-08-01	HUMAN PRESCRIPTION DRUG LABEL	22
Theratramadol-60	Physician Therapeutics LLC \| Ameal Pharmaceuticals \| Targeted Medical Pharma Inc. \| H.J. Harkins Company, Inc.	2011-08-01	HUMAN PRESCRIPTION DRUG LABEL	3