tramadol hydrochloride

Product NDC: 68788-8717
Requested package NDC: 68788-8717-9
11-digit product format: 687888717
Labeler code: 68788
Product ID: 68788-8717_12af9122-aed2-461a-b7fc-e48a030d59a8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tramadol hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA202075
Marketing category: ANDA
Marketing start: 2024-07-18
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: 2026-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202075-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2011-11-28
A202075-002	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2026-03-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A202075-001	AB
A202075-002	AB

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
2026-02-19 14:30 UTC	2026-02	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202075-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202075-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202075-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202075-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202075-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202075-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202075-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202075-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202075-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202075-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202075-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202075-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202075-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202075-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202075-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202075-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202075-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202075-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202075-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202075-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202075-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202075-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202075-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202075-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202075-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202075-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202075-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202075-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202075-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202075-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202075-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202075-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202075-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202075-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202075-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202075-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202075-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202075-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202075-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202075-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: tramadol hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRAMADOL HYDROCHLORIDE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9N7R477WCK	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
835603	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
05f8e06b-f3eb-4cb2-aee5-bd0b03884178	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68788-8717-1	tramadol hydrochloride	100 in 1 BOTTLE	TABLET	100	2
68788-8717-2	tramadol hydrochloride	20 in 1 BOTTLE	TABLET	20	2
68788-8717-3	tramadol hydrochloride	30 in 1 BOTTLE	TABLET	30	2
68788-8717-4	tramadol hydrochloride	40 in 1 BOTTLE	TABLET	40	2
68788-8717-5	tramadol hydrochloride	15 in 1 BOTTLE	TABLET	15	2
68788-8717-6	tramadol hydrochloride	60 in 1 BOTTLE	TABLET	60	2
68788-8717-7	tramadol hydrochloride	50 in 1 BOTTLE	TABLET	50	2
68788-8717-8	tramadol hydrochloride	120 in 1 BOTTLE	TABLET	120	2
68788-8717-9	tramadol hydrochloride	90 in 1 BOTTLE	TABLET	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8717-1	EA - Each	68788-8717	84664a90-422c-4f9d-a008-875e31f3abe1	1	2024-09-09
68788-8717-2	EA - Each	68788-8717	c825ec0b-77f0-451e-9234-f714414fec2f	1	2024-09-09
68788-8717-3	EA - Each	68788-8717	81ac1ab1-1446-4704-aede-f43832c106ef	1	2024-09-09
68788-8717-4	EA - Each	68788-8717	71734899-1661-442c-af43-b364273d3821	1	2024-09-09
68788-8717-5	EA - Each	68788-8717	21fd3d29-9781-49ee-bd2f-6b0e8452621c	1	2024-09-09
68788-8717-6	EA - Each	68788-8717	57982710-5243-471d-b53c-f87b5b3b5b92	1	2024-09-09
68788-8717-7	EA - Each	68788-8717	6bc8e6c8-3d6b-4f28-a93a-2676c76a4fe8	1	2024-09-09
68788-8717-8	EA - Each	68788-8717	55e3bf24-7378-4270-9b03-27414db3d8b1	1	2024-09-09
68788-8717-9	EA - Each	68788-8717	b9786e62-87ea-4a99-be3b-96282489f6df	1	2024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8717	TRAMADOL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]	1	Current NDC, 9 package rows	20240730_05f8e06b-f3eb-4cb2-aee5-bd0b03884178.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 · 8 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	a886d551-6b57-4d9d-87f4-e1366385c7fd	2026-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202075 application number: ANDA202075
tramadol hydrochloride	TRAMADOL HYDROCHLORIDE	Northwind Health Company, LLC	1b5360f8-3e95-a047-e063-6294a90a7315	2025-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202075 application number: ANDA202075
tramadol hydrochloride	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	05f8e06b-f3eb-4cb2-aee5-bd0b03884178	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202075 application number: ANDA202075 ndc (package): 68788-8717-9 ndc (product): 68788-8717 ndc11 (package): 68788871709
tramadol hydrochloride	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	c6104e62-5b2c-41a1-afb3-00dcf267a384	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202075 application number: ANDA202075
tramadol hydrochloride	TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	1e79e1fa-3473-f4a7-e063-6294a90a9576	2025-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202075 application number: ANDA202075
tramadol hydrochloride	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	6ebc5864-c222-4400-a9b2-f66fd6fb0da6	2024-11-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202075 application number: ANDA202075
tramadol hydrochloride	TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	1cd3caee-bf54-7aba-e063-6394a90ad8cb	2024-10-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202075 application number: ANDA202075
tramadol hydrochloride	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	2236031d-8596-4c21-8b16-83aa3e4122c1	2024-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202075 application number: ANDA202075

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
835603	traMADol HCl 50 MG Oral Tablet	PSN	05f8e06b-f3eb-4cb2-aee5-bd0b03884178	2
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	05f8e06b-f3eb-4cb2-aee5-bd0b03884178	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-8717-9	68788871709	90 TABLET in 1 BOTTLE (68788-8717-9)	90 tablet	2024-07-18	No	No	Current