Tramadol Hydrochloride and Acetaminophen

Product NDC: 68071-2351
11-digit product format: 680712351
Labeler code: 68071
Product ID: 68071-2351_ea64909a-063d-a08f-e053-2995a90a07c3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tramadol Hydrochloride and Acetaminophen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA207152
Marketing category: ANDA
Marketing start: 2017-03-22
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Active strength: 325 mg/1; 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68071-2351		I	Inactivated by FDA		2026-08-03
excluded package	package	68071-2351	68071-2351-1	I	Inactivated by FDA		2026-08-03

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2351-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2351-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2351-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2351-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2351-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2351-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2351-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2351-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2351-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	325MG;37.5MG	TABLET / ORAL	AB		2017-03-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207152-001	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 · 41 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	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A207152-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207152-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207152-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207152-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207152-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207152-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207152-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207152-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207152-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207152-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207152-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207152-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207152-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207152-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207152-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207152-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207152-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207152-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207152-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207152-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207152-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207152-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207152-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207152-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207152-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207152-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207152-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207152-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207152-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207152-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207152-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207152-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207152-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207152-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207152-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207152-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207152-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207152-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207152-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207152-001	AB	1	`cb3db0bc1861…`

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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2351-1	2025-01-30	C162847	48780-1	2cef2736-8692-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN TABLETS. TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN tablets, for oral use, CIV Initial U.S. Approval – 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2351-1	Tramadol Hydrochloride and Acetaminophen	16 in 1 BOTTLE	TABLET, FILM COATED	16		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2351	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]	2	Legacy NDC, 1 package rows	20221008_bb9e87d4-3598-8caa-e053-2a95a90ac6d0.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 and Acetaminophen	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	St. Mary's Medical Park Pharmacy	cb05d615-918d-8104-e053-2995a90aa96b	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207152 application number: ANDA207152
Tramadol Hydrochloride and Acetaminophen	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Bryant Ranch Prepack	ccf465b5-8ef8-4445-a0d4-23b5cf13188c	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207152 application number: ANDA207152
Tramadol Hydrochloride and Acetaminophen	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Bryant Ranch Prepack	c83366d9-db60-45eb-9c2b-a2c58d45c82c	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207152 application number: ANDA207152
Tramadol Hydrochloride and Acetaminophen	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Aurobindo Pharma Limited	6c2894df-eeeb-4b22-ab32-8ce1601bfdfa	2025-11-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207152 application number: ANDA207152
Tramadol Hydrochloride and Acetaminophen	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	REMEDYREPACK INC.	5058c2b0-5c66-4cd2-80a6-7a4678c1fd51	2025-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207152 application number: ANDA207152
Tramadol Hydrochloride and Acetaminophen	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Direct_Rx	e8a7c995-e473-ca87-e053-2995a90a5b80	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207152 application number: ANDA207152
Tramadol Hydrochloride and Acetaminophen	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Medsource Pharmaceuticals	12f113b3-d6b1-a7b0-e063-6294a90a999d	2024-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207152 application number: ANDA207152
Tramadol Hydrochloride and Acetaminophen	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Proficient Rx LP	d9fa3057-c7a5-46cf-a79e-abf99a4f804d	2022-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207152 application number: ANDA207152

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
9N7R477WCK	TRAMADOL HYDROCHLORIDE	36282-47-0	TRAMADOL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
836395	traMADol HCl 37.5 MG / acetaminophen 325 MG Oral Tablet	PSN	bb9e87d4-3598-8caa-e053-2a95a90ac6d0	2
836395	acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet	SCD	bb9e87d4-3598-8caa-e053-2a95a90ac6d0	2
836395	APAP 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet	SY	bb9e87d4-3598-8caa-e053-2a95a90ac6d0	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2351-1	68071235101	16 TABLET, FILM COATED in 1 BOTTLE (68071-2351-1)	2021-02-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tramadol Hydrochloride and Acetaminophen	NuCare Pharmaceuticals,Inc.	2022-10-06	HUMAN PRESCRIPTION DRUG LABEL	2