Tramadol Hydrochloride

Product NDC: 80425-0588
Requested package NDC: 80425-0588-4
11-digit product format: 804250588
Labeler code: 80425
Product ID: 80425-0588_552e6399-c3c3-d362-e063-6394a90a0f8f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tramadol Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Advanced Rx of Tennessee, LLC
Application: ANDA075968
Marketing category: ANDA
Marketing start: 2026-06-26
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: 2027-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A075968-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-25
A075968-002	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-02
A075968-003	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2026-07-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A075968-001	AB
A075968-002	AB
A075968-003	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 · 59 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
2026-09-14 22:38:34	2026-08	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075968-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075968-003	TRAMADOL HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2026-07-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075968-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075968-003	TRAMADOL HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2026-07-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075968-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075968-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075968-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075968-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075968-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075968-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075968-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075968-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075968-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075968-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075968-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`8869cabd3fbd…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075968-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075968-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075968-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075968-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075968-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075968-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075968-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075968-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075968-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075968-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075968-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075968-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075968-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075968-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075968-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075968-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075968-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075968-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075968-002	AB	1	`79d66fd596c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075968-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075968-002	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Tramadol Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRAMADOL HYDROCHLORIDE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9N7R477WCK	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
835603	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
552e5b32-accf-29dd-e063-6294a90a4fcf	Available on FDA.report

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	42de8c3a-0441-5d46-e063-6294a90a2079	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075968 application number: ANDA075968
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	552e5b32-accf-29dd-e063-6294a90a4fcf	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075968 application number: ANDA075968 ndc (package): 80425-0588-4 ndc (product): 80425-0588 ndc11 (package): 80425058804
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	515baa9a-b226-4bbe-be87-f9befdf1c9e1	2026-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075968 application number: ANDA075968
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	855905c7-1481-4b2d-a318-3254ad8ed73c	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075968 application number: ANDA075968
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Rising Pharma Holdings, Inc.	b5852b90-e415-47ef-8f73-87266b58e033	2026-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075968 application number: ANDA075968

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	Sample	Exclude flag	Status
80425-0588-4	80425058804	60 TABLET in 1 BOTTLE (80425-0588-4)	60 tablet	2026-06-26	No	No	Current