TRAMADOL HYDROCHLORIDE

Product NDC: 68788-7762
Requested package NDC: 68788-7762-9
11-digit product format: 687887762
Labeler code: 68788
Product ID: 68788-7762_820477b9-3601-4aeb-b262-b30c01129c88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TRAMADOL HYDROCHLORIDE
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA201384
Marketing category: ANDA
Marketing start: 2020-07-22
Marketing end: 0000-00-00
Substance: TRAMADOL HYDROCHLORIDE
Active strength: 200 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2023-12-31
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	68788-7762	68788-7762-9	D	Discontinued by firm		2026-08-07

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 · 11 matching rows.

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

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A201384-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-07
A201384-002	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-07
A201384-003	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-07

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 4 · 123 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	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201384-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201384-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201384-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201384-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201384-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201384-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201384-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201384-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201384-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201384-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201384-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201384-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201384-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201384-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201384-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201384-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201384-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201384-003	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201384-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201384-002	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201384-003	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201384-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201384-002	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201384-003	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201384-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201384-002	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201384-003	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201384-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201384-002	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201384-003	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201384-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201384-002	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201384-003	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201384-001	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201384-002	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201384-003	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201384-001	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201384-002	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201384-003	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201384-001	AB1	1	`87673890dc5c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7762-2	EA - Each	68788-7762	c3c807aa-adfa-4761-b9e7-80e81f3fc6c1	1	2020-09-14
68788-7762-3	EA - Each	68788-7762	dcb75afa-3eb1-46a9-9a68-c298e73e2889	1	2020-09-14
68788-7762-6	EA - Each	68788-7762	32d2ca78-9fc1-45c8-a646-a9adca6eaf64	1	2020-09-14
68788-7762-9	EA - Each	68788-7762	611496a1-8172-4ae0-997f-b9b593ef9f66	1	2020-09-14

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	66359f41-9999-4cb8-b632-1fe2ec1e60b2	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201384 application number: ANDA201384
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	43fe10b2-17a4-4dc2-9a48-2378547b61fd	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201384 application number: ANDA201384
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	a77b0dba-8ac7-418a-b435-16a0e6c22804	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201384 application number: ANDA201384
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	004de5a4-80f8-4040-a6ea-be5e99352a36	2025-11-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201384 application number: ANDA201384
Tramadol HCL ER	TRAMADOL HCL	Advanced Rx Pharmacy of Tennessee, LLC	c197f4e4-9ea5-562b-e053-2a95a90a975c	2024-11-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201384 application number: ANDA201384
TRAMADOL HCL ER	TRAMADOL HCL	DIRECT RX	5285f056-c32c-4e7a-bec6-3a726aa23d5a	2024-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201384 application number: ANDA201384
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	00b7f61b-5173-43e6-a3f9-d2efbda40c19	2022-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201384 application number: ANDA201384
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Asclemed USA, Inc.	dce0d21e-e4c2-4875-a2ce-9d53df190b80	2022-07-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201384 application number: ANDA201384
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	27495d02-8641-4c92-b5a3-edf50abc2a6f	2022-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201384 application number: ANDA201384
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	68646295-49b2-45ac-bf19-99bb91f7333d	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201384 application number: ANDA201384

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
68788-7762-9	68788776209	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7762-9)	2020-07-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	2023-10-03	HUMAN PRESCRIPTION DRUG LABEL	4