TRAMADOL HYDROCHLORIDE

Product NDC: 61919-002
11-digit product format: 619190002
Labeler code: 61919
Product ID: 61919-002_0f4b59e9-2438-4aa1-956d-8acc76f51cdf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TRAMADOL HYDROCHLORIDE
Dosage form: CAPSULE, COATED, EXTENDED RELEASE
Route: ORAL
Labeler: DIRECT RX
Application: NDA022370
Marketing category: NDA
Marketing start: 2014-01-01
Marketing end: 0000-00-00
Substance: TRAMADOL HYDROCHLORIDE
Active strength: 150 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	61919-002		I	Inactivated by FDA	2026-08-17
excluded package	package	61919-002	61919-002-30	I	Inactivated by FDA	2026-08-17
excluded package	package	61919-002	61919-002-60	I	Inactivated by FDA	2026-08-17
excluded package	package	61919-002	61919-002-72	I	Inactivated by FDA	2026-08-17
excluded package	package	61919-002	61919-002-90	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	61919-002-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-002-72	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-002-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-002-90	`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	61919-002-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-002-72	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-002-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-002-90	`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	61919-002-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-002-72	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-002-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-002-90	`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	61919-002-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-002-72	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-002-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-002-90	`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	61919-002-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-002-72	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-002-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-002-90	`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	61919-002-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-002-72	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-002-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-002-90	`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	61919-002-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-002-72	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-002-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-002-90	`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	61919-002-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-002-72	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-002-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-002-90	`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	61919-002-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-002-72	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-002-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-002-90	`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	61919-002-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-002-72	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-002-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-002-90	`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	61919-002-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-002-72	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-002-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-002-90	`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	61919-002-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-002-72	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-002-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-002-90	`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
61919-002-30	TRAMADOL HYDROCHLORIDE
61919-002-60	TRAMADOL HYDROCHLORIDE
61919-002-72	TRAMADOL HYDROCHLORIDE
61919-002-90	TRAMADOL HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-002-30	TRAMADOL HYDROCHLORIDE	30 in 1 BOTTLE	CAPSULE, COATED, EXTENDED RELEAS	30	3
61919-002-60	TRAMADOL HYDROCHLORIDE	60 in 1 BOTTLE	CAPSULE, COATED, EXTENDED RELEAS	60	3
61919-002-72	TRAMADOL HYDROCHLORIDE	100 in 1 BOTTLE	CAPSULE, COATED, EXTENDED RELEAS	100	3
61919-002-90	TRAMADOL HYDROCHLORIDE	90 in 1 BOTTLE	CAPSULE, COATED, EXTENDED RELEAS	90	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-002-30	EA - Each	61919-002	7388005e-e820-4572-bd61-364fd14ea6f5	1	2014-08-01
61919-002-60	EA - Each	61919-002	f9bc2b28-56f7-4d0f-bc24-345a47e1e2a5	1	2014-08-01
61919-002-72	EA - Each	61919-002	ee9189e5-85d0-4d60-9896-cb991ddeb4ee	1	2015-06-09
61919-002-90	EA - Each	61919-002	4dc47050-3f95-4bf9-a086-24efa5ccb5de	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]	3
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]	3
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)	INACTIVE INGREDIENT	P2OM2Q86BI	TRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]	3
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	TRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	TRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]	3
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	TRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]	3
SUCROSE STEARATE	INACTIVE INGREDIENT	274KW0O50M	TRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-002	TRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]	3	Legacy NDC, 4 package rows	20150514_476ec70a-0737-42ed-a374-c3b9dc0ce5ca.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	476ec70a-0737-42ed-a374-c3b9dc0ce5ca	3
1248115	24 HR tramadol hydrochloride 150 MG Extended Release Oral Capsule	SCD	476ec70a-0737-42ed-a374-c3b9dc0ce5ca	3
1248115	tramadol HCl 150 MG 24 HR Extended Release Oral Capsule	SY	476ec70a-0737-42ed-a374-c3b9dc0ce5ca	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
61919-002-30	61919000230	30 in 1 BOTTLE	Historical
61919-002-60	61919000260	60 in 1 BOTTLE	Historical
61919-002-72	61919000272	100 in 1 BOTTLE	Historical
61919-002-90	61919000290	90 in 1 BOTTLE	Historical