Tramadol Hydrochloride

Product NDC: 60429-588
Requested package NDC: 60429-588-01
11-digit product format: 604290588
Labeler code: 60429
Product ID: 60429-588_d44ede44-4378-1aaa-e053-2995a90a6fa1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tramadol Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Golden State Medical Supply, Inc.
Application: ANDA075977
Marketing category: ANDA
Marketing start: 2002-06-19
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: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	60429-588	60429-588-01	D	Discontinued by firm		2026-08-11

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
A075977-001	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
A075977-001	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	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075977-001	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	A075977-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075977-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075977-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075977-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075977-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075977-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075977-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075977-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075977-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075977-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075977-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075977-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075977-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075977-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075977-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075977-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075977-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075977-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075977-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075977-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075977-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075977-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075977-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075977-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075977-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075977-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075977-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075977-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075977-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075977-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075977-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075977-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075977-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075977-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075977-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075977-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075977-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075977-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075977-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075977-001	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
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60429-588-01	EA - Each	60429-588	72cdd5f2-b6fa-474b-ae99-4d0dc433d407	1	2017-10-13
60429-588-05	EA - Each	60429-588	b95c6758-82ad-4308-a47b-84a5e723d6e4	1	2017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60429-588	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	10	Legacy NDC	20240302_41d1db45-4d05-49cb-8de5-9444dcf08a6f.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Golden State Medical Supply, Inc.	24aea499-c6f1-9200-e063-6394a90a9db6	2026-02-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075977 application number: ANDA075977
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	561f00e5-f69c-4369-ae4d-5eff86c4499f	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075977 application number: ANDA075977
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	27460cc6-0782-7838-e063-6394a90a19f1	2024-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075977 application number: ANDA075977
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	bbd6c0d4-110c-4bda-9d9f-89ab7ce4c18e	2019-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075977 application number: ANDA075977

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	bbd6c0d4-110c-4bda-9d9f-89ab7ce4c18e	3
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	bbd6c0d4-110c-4bda-9d9f-89ab7ce4c18e	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60429-588-01	60429058801	100 TABLET, FILM COATED in 1 BOTTLE (60429-588-01)	2017-06-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tramadol Hydrochloride	Golden State Medical Supply, Inc.	2025-07-24	HUMAN PRESCRIPTION DRUG LABEL	11
Tramadol Hydrochloride Tablets USP, 50 mg	Aphena Pharma Solutions - Tennessee, LLC	2019-04-04	HUMAN PRESCRIPTION DRUG LABEL	3