Tramadol HCL

Product NDC: 80425-0159
11-digit product format: 804250159
Labeler code: 80425
Product ID: 80425-0159_ed357999-3616-fd99-e053-2995a90a9ac6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tramadol HCL
Dosage form: TABLET
Route: ORAL
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Application: ANDA075964
Marketing category: ANDA
Marketing start: 2002-06-22
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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	80425-0159		D	Discontinued by firm	2026-08-07
excluded package	package	80425-0159	80425-0159-1	D	Discontinued by firm	2026-08-07
excluded package	package	80425-0159	80425-0159-2	D	Discontinued by firm	2026-08-07
excluded package	package	80425-0159	80425-0159-3	D	Discontinued by firm	2026-08-07
excluded package	package	80425-0159	80425-0159-4	D	Discontinued by firm	2026-08-07
excluded package	package	80425-0159	80425-0159-5	D	Discontinued by firm	2026-08-07
excluded package	package	80425-0159	80425-0159-6	D	Discontinued by firm	2026-08-07
excluded package	package	80425-0159	80425-0159-7	D	Discontinued by firm	2026-08-07

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
A075964-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075964-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`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	A075964-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075964-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075964-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075964-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075964-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075964-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075964-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075964-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075964-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075964-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075964-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075964-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075964-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075964-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075964-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075964-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075964-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075964-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075964-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075964-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075964-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075964-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075964-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075964-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075964-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075964-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075964-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075964-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075964-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075964-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075964-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075964-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075964-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075964-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075964-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075964-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075964-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075964-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075964-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075964-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0159-1	EA - Each	80425-0159	bf2bcb29-d626-4bf5-885e-b50d3c7aa338	1	2023-03-13
80425-0159-2	EA - Each	80425-0159	d8594b82-4c9e-4268-815c-dd61d4bd4877	1	2023-03-13
80425-0159-3	EA - Each	80425-0159	4ab0d8cb-466a-4f89-81e9-4e73c1f9bd72	1	2023-03-13
80425-0159-4	EA - Each	80425-0159	1f97f9b6-e810-48de-9193-2214f4da2b3f	1	2023-03-13
80425-0159-5	EA - Each	80425-0159	aabb1e58-cd07-4e36-9e2d-a387e0451528	1	2023-03-13
80425-0159-6	EA - Each	80425-0159	6fa431bb-848d-49b3-ba1e-894be21f3bd2	1	2023-03-13
80425-0159-7	EA - Each	80425-0159	60ed6ff0-efb8-4bed-af4d-16d86119601a	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0159	TRAMADOL HCL TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]	11	Legacy NDC	20240601_c898741e-eebb-b4a0-e053-2a95a90a088f.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9N7R477WCK	TRAMADOL HYDROCHLORIDE	36282-47-0	TRAMADOL HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80425-0159-1	80425015901	15 TABLET in 1 BOTTLE (80425-0159-1)	15 tablet	2002-06-22	0000-00-00	No	No	Current
80425-0159-2	80425015902	30 TABLET in 1 BOTTLE (80425-0159-2)	30 tablet	2002-06-22	0000-00-00	No	No	Current
80425-0159-3	80425015903	60 TABLET in 1 BOTTLE (80425-0159-3)	60 tablet	2002-06-22	0000-00-00	No	No	Current
80425-0159-4	80425015904	90 TABLET in 1 BOTTLE (80425-0159-4)	90 tablet	2002-06-22	0000-00-00	No	No	Current
80425-0159-5	80425015905	120 TABLET in 1 BOTTLE (80425-0159-5)	120 tablet	2002-06-22	0000-00-00	No	No	Current
80425-0159-6	80425015906	40 TABLET in 1 BOTTLE (80425-0159-6)	40 tablet	2002-06-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tramadol HCL 50mg Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-05-30	HUMAN PRESCRIPTION DRUG LABEL	11