Tramadol Hydrochloride

Product NDC: 0093-0058
Requested package NDC: 0093-0058-05
11-digit product format: 000930058
Labeler code: 0093
Product ID: 0093-0058_c74a886e-2684-4279-8c05-ad608245d856
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tramadol Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA075977
Marketing category: ANDA
Marketing start: 2002-06-20
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	0093-0058	0093-0058-05	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-0058-01	EA - Each	0093-0058	5cb15466-8bf6-4448-a1a5-a2c06cf06525	1	2012-07-24
0093-0058-05	EA - Each	0093-0058	76c0c547-c43a-46f0-b9ac-d37cc1ea2138	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	8
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	8
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	8
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	8
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	8
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	8
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-0058	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]	28	Legacy NDC	20240919_6d3b4049-2bfd-4874-b984-8fb231bff27c.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-0058-05	00093005805	500 TABLET, FILM COATED in 1 BOTTLE (0093-0058-05)	2002-07-03	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	Teva Pharmaceuticals USA, Inc.	2024-09-12	HUMAN PRESCRIPTION DRUG LABEL	28
Tramadol Hydrochloride	REMEDYREPACK INC.	2024-01-15	HUMAN PRESCRIPTION DRUG LABEL	3