Tramadol Hydrochloride

Product NDC: 0378-4151
11-digit product format: 003784151
Labeler code: 0378
Product ID: 0378-4151_4d69cadb-219a-4f9b-8823-337a83fab981
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tramadol hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA075986
Marketing category: ANDA
Marketing start: 2002-06-21
Marketing end: 2022-08-31
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: 0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0378-4151		D	Discontinued by firm	2026-08-17
excluded package	package	0378-4151	0378-4151-01	D	Discontinued by firm	2026-08-17
excluded package	package	0378-4151	0378-4151-05	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0378-4151-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0378-4151-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0378-4151-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0378-4151-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0378-4151-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0378-4151-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0378-4151-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0378-4151-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0378-4151-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0378-4151-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0378-4151-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0378-4151-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0378-4151-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0378-4151-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0378-4151-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0378-4151-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0378-4151-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0378-4151-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-4151-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-4151-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-4151-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-4151-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-4151-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-4151-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A075986-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL			2002-06-21

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
2026-08-18 06:07:40	2026-07	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075986-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-21	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075986-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075986-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075986-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075986-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075986-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075986-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075986-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075986-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075986-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075986-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075986-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075986-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075986-001	AB	1	`ea99ee380514…`
2022-09-29 23:25 UTC	2022-09	A075986-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075986-001	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
0378-4151-01	EA - Each	0378-4151	6ad79146-f75a-4354-a5f7-885920fa9769	1	2012-07-24
0378-4151-05	EA - Each	0378-4151	38c15e17-a042-4382-b3ea-1884994881c9	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 [MYLAN INSTITUTIONAL INC.]	6
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	6
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	6
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	6
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	6
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	6
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	6
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1

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
0378-4151-01	00378415101	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4151-01)	2002-06-21	0000-00-00	No	No	Current
0378-4151-05	00378415105	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4151-05)	2002-06-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tramadol Hydrochloride	Mylan Institutional Inc.	2021-12-23	HUMAN PRESCRIPTION DRUG LABEL	17
Tramadol Hydrochloride	RPK Pharmaceuticals, Inc.	2021-07-26	HUMAN PRESCRIPTION DRUG LABEL	2
Tramadol 50mg	RedPharm Drug, Inc.	2021-04-23	HUMAN PRESCRIPTION DRUG LABEL	8
Tramadol Hydrochloride	A-S Medication Solutions	2021-01-14	HUMAN PRESCRIPTION DRUG LABEL	1
Tramadol Hydrochloride	Mylan Pharmaceuticals Inc.	2019-11-18	HUMAN PRESCRIPTION DRUG LABEL	12
Tramadol HCl Tabs 50mg	NCS HealthCare of KY, Inc dba Vangard Labs	2015-05-07	HUMAN PRESCRIPTION DRUG LABEL	1