Tramadol Hydrochloride

Product NDC: 68071-1978
Requested package NDC: 68071-1978-3
11-digit product format: 680711978
Labeler code: 68071
Product ID: 68071-1978_bc05ebda-b263-f773-e053-2995a90a25d5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tramadol Hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: NDA022370
Marketing category: NDA
Marketing start: 2015-07-01
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: 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	68071-1978	68071-1978-3	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 · 15 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68071-1978-1	2024-07-16	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
68071-1978-3	2024-07-16	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
68071-1978-6	2024-07-16	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
68071-1978-9	2024-07-16	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
68071-1978-1	2023-01-30	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
68071-1978-3	2023-01-30	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
68071-1978-6	2023-01-30	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
68071-1978-9	2023-01-30	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
68071-1978-1	2021-02-23	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
68071-1978-3	2021-02-23	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
68071-1978-6	2021-02-23	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
68071-1978-9	2021-02-23	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
68071-1978-1	2021-01-29	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
68071-1978-3	2021-01-29	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
68071-1978-6	2021-01-29	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
68071-1978-9	2021-01-29	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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-1978-3	68071197803	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68071-1978-3)	2017-02-21	0000-00-00	No	No	Current