tramadol hydrochloride

Product NDC: 60760-588
Requested package NDC: 60760-588-50
11-digit product format: 607600588
Labeler code: 60760
Product ID: 60760-588_3fa66c6a-130c-7945-e063-6294a90af0bd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tramadol hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: ST. MARY'S MEDICAL PARK PHARMACY
Application: ANDA202075
Marketing category: ANDA
Marketing start: 2018-03-01
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: 2026-12-31
Current FDA listing: Yes

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	60760-588	60760-588-50	D	Discontinued by firm		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202075-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2011-11-28
A202075-002	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2026-03-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A202075-001	AB
A202075-002	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
2026-02-19 14:30 UTC	2026-02	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`cb3db0bc1861…`

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
2026-02-19 14:30 UTC	2026-02	A202075-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202075-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202075-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202075-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202075-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202075-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202075-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202075-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202075-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202075-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202075-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202075-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202075-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202075-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202075-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202075-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202075-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202075-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202075-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202075-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202075-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202075-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202075-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202075-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202075-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202075-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202075-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202075-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202075-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202075-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202075-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202075-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202075-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202075-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202075-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202075-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202075-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202075-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202075-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202075-001	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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
60760-588-09	tramadol hydrochloride	9 in 1 BOTTLE, PLASTIC	TABLET	9	5
60760-588-20	tramadol hydrochloride	20 in 1 BOTTLE, PLASTIC	TABLET	20	5
60760-588-30	tramadol hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET	30	5
60760-588-50	tramadol hydrochloride	50 in 1 BOTTLE, PLASTIC	TABLET	50	5
60760-588-60	tramadol hydrochloride	60 in 1 BOTTLE, PLASTIC	TABLET	60	5
60760-588-90	tramadol hydrochloride	90 in 1 BOTTLE, PLASTIC	TABLET	90	5
60760-588-92	tramadol hydrochloride	120 in 1 BOTTLE, PLASTIC	TABLET	120	5
60760-588-98	tramadol hydrochloride	180 in 1 BOTTLE, PLASTIC	TABLET	180	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60760-588-09	EA - Each	60760-588	8044d3d1-d90b-409e-8d4d-ea3e128cd54c	1	2025-05-14
60760-588-20	EA - Each	60760-588	36eaea44-cbe1-4348-9f25-e8b0c2f1ee1c	1	2024-04-05
60760-588-30	EA - Each	60760-588	7bf17a3a-ccba-4d08-8dc6-a1f40e204a53	1	2023-12-05
60760-588-50	EA - Each	60760-588	9313f527-6288-4252-843a-075e7cff9d47	1	2023-12-05
60760-588-60	EA - Each	60760-588	36d78c0e-97d4-475f-b0d0-64e94a261b12	1	2024-07-12
60760-588-90	EA - Each	60760-588	19faefea-5efd-49d4-9d6c-1b3dcd11d199	1	2023-12-05
60760-588-92	EA - Each	60760-588	d9c07bec-8afa-492e-a0f0-80ee36a8642a	1	2025-11-13
60760-588-98	EA - Each	60760-588	46bce7e8-015a-48a3-8a9f-e4ce6e92f26b	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60760-588	TRAMADOL HYDROCHLORIDE TABLET [ST. MARY'S MEDICAL PARK PHARMACY]	4	Current NDC, 8 package rows	20250315_087a7afe-ac1f-a201-e063-6394a90a260d.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
tramadol hydrochloride	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	a886d551-6b57-4d9d-87f4-e1366385c7fd	2026-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202075 application number: ANDA202075
tramadol hydrochloride	TRAMADOL HYDROCHLORIDE	Northwind Health Company, LLC	1b5360f8-3e95-a047-e063-6294a90a7315	2025-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202075 application number: ANDA202075
tramadol hydrochloride	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	05f8e06b-f3eb-4cb2-aee5-bd0b03884178	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202075 application number: ANDA202075
tramadol hydrochloride	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	c6104e62-5b2c-41a1-afb3-00dcf267a384	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202075 application number: ANDA202075
tramadol hydrochloride	TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	1e79e1fa-3473-f4a7-e063-6294a90a9576	2025-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202075 application number: ANDA202075
tramadol hydrochloride	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	6ebc5864-c222-4400-a9b2-f66fd6fb0da6	2024-11-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202075 application number: ANDA202075
tramadol hydrochloride	TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	1cd3caee-bf54-7aba-e063-6394a90ad8cb	2024-10-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202075 application number: ANDA202075
tramadol hydrochloride	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	2236031d-8596-4c21-8b16-83aa3e4122c1	2024-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202075 application number: ANDA202075

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	087a7afe-ac1f-a201-e063-6394a90a260d	5
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	087a7afe-ac1f-a201-e063-6394a90a260d	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
60760-588-50	60760058850	50 TABLET in 1 BOTTLE, PLASTIC (60760-588-50)	50 tablet	2023-10-06	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
tramadol hydrochloride	ST. MARY'S MEDICAL PARK PHARMACY	2025-09-25	HUMAN PRESCRIPTION DRUG LABEL	5