Tramadol Hydrochloride

Product NDC: 69677-316
11-digit product format: 696770316
Labeler code: 69677
Product ID: 69677-316_5b3602f4-54f1-9461-e053-2a91aa0a99b9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tramadol Hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Mas Management Group, Inc.
Application: NDA022370
Marketing category: NDA
Marketing start: 2017-07-01
Marketing end: 0000-00-00
Substance: TRAMADOL HYDROCHLORIDE
Active strength: 150 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule: CIV
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69677-316		I	Inactivated by FDA	2026-08-17
excluded package	package	69677-316	69677-316-01	I	Inactivated by FDA	2026-08-17
excluded package	package	69677-316	69677-316-30	I	Inactivated by FDA	2026-08-17
excluded package	package	69677-316	69677-316-60	I	Inactivated by FDA	2026-08-17
excluded package	package	69677-316	69677-316-90	I	Inactivated by FDA	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 2 · 110 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	69677-316-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69677-316-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69677-316-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69677-316-90	`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	69677-316-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69677-316-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69677-316-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69677-316-90	`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	69677-316-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69677-316-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69677-316-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69677-316-90	`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	69677-316-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69677-316-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69677-316-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69677-316-90	`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	69677-316-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69677-316-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69677-316-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69677-316-90	`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	69677-316-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69677-316-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69677-316-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69677-316-90	`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	69677-316-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69677-316-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69677-316-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69677-316-90	`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	69677-316-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69677-316-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69677-316-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69677-316-90	`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	69677-316-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69677-316-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69677-316-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69677-316-90	`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	69677-316-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69677-316-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69677-316-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69677-316-90	`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	69677-316-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69677-316-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69677-316-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69677-316-90	`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	69677-316-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69677-316-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69677-316-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69677-316-90	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N022370-001	CONZIP	TRAMADOL HYDROCHLORIDE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2010-05-07
N022370-002	CONZIP	TRAMADOL HYDROCHLORIDE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-05-07
N022370-003	CONZIP	TRAMADOL HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-05-07
N022370-004	CONZIP	TRAMADOL HYDROCHLORIDE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2011-08-01

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 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022370-001	CONZIP	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2010-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022370-002	CONZIP	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022370-003	CONZIP	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022370-004	CONZIP	150MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2011-08-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022370-001	CONZIP	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2010-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022370-002	CONZIP	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022370-003	CONZIP	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022370-004	CONZIP	150MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2011-08-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022370-001	CONZIP	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2010-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022370-002	CONZIP	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022370-003	CONZIP	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022370-004	CONZIP	150MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2011-08-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022370-001	CONZIP	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2010-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022370-002	CONZIP	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022370-003	CONZIP	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022370-004	CONZIP	150MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2011-08-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022370-001	CONZIP	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2010-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022370-002	CONZIP	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022370-003	CONZIP	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022370-004	CONZIP	150MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2011-08-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022370-001	CONZIP	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2010-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022370-002	CONZIP	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022370-003	CONZIP	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022370-004	CONZIP	150MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2011-08-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022370-001	CONZIP	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2010-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022370-002	CONZIP	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022370-003	CONZIP	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022370-004	CONZIP	150MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2011-08-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022370-001	CONZIP	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2010-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022370-002	CONZIP	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022370-003	CONZIP	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022370-004	CONZIP	150MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2011-08-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022370-001	CONZIP	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2010-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022370-002	CONZIP	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022370-003	CONZIP	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022370-004	CONZIP	150MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2011-08-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022370-001	CONZIP	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2010-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022370-002	CONZIP	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022370-003	CONZIP	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022370-004	CONZIP	150MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2011-08-01	`d8e5a09893c0…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022370-001	7858118	2022-04-11	U-1104	Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022370-002	7858118	2022-04-11	U-1104	Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022370-003	7858118	2022-04-11	U-1104	Drug product	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022370-001	7858118	2022-04-11	U-1104	Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022370-002	7858118	2022-04-11	U-1104	Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022370-003	7858118	2022-04-11	U-1104	Drug product	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022370-001	7858118	2022-04-11	U-1104	Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022370-002	7858118	2022-04-11	U-1104	Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022370-003	7858118	2022-04-11	U-1104	Drug product	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022370-001	7858118	2022-04-11	U-1104	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022370-002	7858118	2022-04-11	U-1104	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022370-003	7858118	2022-04-11	U-1104	Drug product	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022370-001	7858118	2022-04-11	U-1104	Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022370-002	7858118	2022-04-11	U-1104	Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022370-003	7858118	2022-04-11	U-1104	Drug product	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022370-001	7858118	2022-04-11	U-1104	Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022370-002	7858118	2022-04-11	U-1104	Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022370-003	7858118	2022-04-11	U-1104	Drug product	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022370-001	7858118	2022-04-11	U-1104	Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022370-002	7858118	2022-04-11	U-1104	Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022370-003	7858118	2022-04-11	U-1104	Drug product	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022370-001	7858118	2022-04-11	U-1104	Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022370-002	7858118	2022-04-11	U-1104	Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022370-003	7858118	2022-04-11	U-1104	Drug product	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022370-001	7858118	2022-04-11	U-1104	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022370-002	7858118	2022-04-11	U-1104	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022370-003	7858118	2022-04-11	U-1104	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022370-001	7858118	2022-04-11	U-1104	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022370-002	7858118	2022-04-11	U-1104	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022370-003	7858118	2022-04-11	U-1104	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022370-001	7858118	2022-04-11	U-1104	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022370-002	7858118	2022-04-11	U-1104	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022370-003	7858118	2022-04-11	U-1104	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022370-001	7858118	2022-04-11	U-1104	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022370-002	7858118	2022-04-11	U-1104	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022370-003	7858118	2022-04-11	U-1104	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022370-001	7858118	2022-04-11	U-1104	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022370-002	7858118	2022-04-11	U-1104	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022370-003	7858118	2022-04-11	U-1104	Drug product	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N022370-001	7858118	2022-04-11	U-1104	Drug product	`3bdfa0b2c4d7…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
69677-316-01	These highlights do not include all the information needed to use Tramadol Hydrochloride Extended- Release Capsules safely and effectively. See full prescribing information for Tramadol Hydrochloride Extended-Release Capsules. Tramadol Hydrochloride Extended-Release Capsules Initial U.S. Approval: 1995
69677-316-30	These highlights do not include all the information needed to use Tramadol Hydrochloride Extended- Release Capsules safely and effectively. See full prescribing information for Tramadol Hydrochloride Extended-Release Capsules. Tramadol Hydrochloride Extended-Release Capsules Initial U.S. Approval: 1995
69677-316-60	These highlights do not include all the information needed to use Tramadol Hydrochloride Extended- Release Capsules safely and effectively. See full prescribing information for Tramadol Hydrochloride Extended-Release Capsules. Tramadol Hydrochloride Extended-Release Capsules Initial U.S. Approval: 1995
69677-316-90	These highlights do not include all the information needed to use Tramadol Hydrochloride Extended- Release Capsules safely and effectively. See full prescribing information for Tramadol Hydrochloride Extended-Release Capsules. Tramadol Hydrochloride Extended-Release Capsules Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69677-316-01	Tramadol Hydrochloride	120 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	120	1
69677-316-30	Tramadol Hydrochloride	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30	1
69677-316-60	Tramadol Hydrochloride	60 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	60	1
69677-316-90	Tramadol Hydrochloride	90 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	90	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69677-316	TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MAS MANAGEMENT GROUP, INC.]	1	Legacy NDC, 4 package rows	20171108_5b3602f4-54f0-9461-e053-2a91aa0a99b9.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tramadol Hydrochloride Extended-Release	TRAMADOL HYDROCHLORIDE	Trigen Laboratories, LLC	c0bc7218-3fd0-4646-96f4-25355fc84aa9	2026-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022370 application number: NDA022370
ConZip	TRAMADOL HYDROCHLORIDE	Vertical Pharmaceuticals, LLC	a65b4d05-3a1c-4aa1-848a-d20ac9aaf62f	2025-12-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022370 application number: NDA022370

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
1248115	traMADol HCl 150 MG 24HR Extended Release Oral Capsule	PSN	5b3602f4-54f0-9461-e053-2a91aa0a99b9	1
1248115	24 HR tramadol hydrochloride 150 MG Extended Release Oral Capsule	SCD	5b3602f4-54f0-9461-e053-2a91aa0a99b9	1
1248115	tramadol HCl 150 MG 24 HR Extended Release Oral Capsule	SY	5b3602f4-54f0-9461-e053-2a91aa0a99b9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
69677-316-01	69677031601	120 in 1 BOTTLE	Historical
69677-316-30	69677031630	30 in 1 BOTTLE	Historical
69677-316-60	69677031660	60 in 1 BOTTLE	Historical
69677-316-90	69677031690	90 in 1 BOTTLE	Historical