Tramadol Hydrochloride and Acetaminophen

Product NDC: 45865-170
11-digit product format: 458650170
Labeler code: 45865
Product ID: 45865-170_12f113b3-d6b2-a7b0-e063-6294a90a999d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tramadol Hydrochloride and Acetaminophen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Medsource Pharmaceuticals
Application: ANDA207152
Marketing category: ANDA
Marketing start: 2017-03-22
Substance: ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Active strength: 325; 37.5 mg/1; 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 · 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Tramadol Hydrochloride and Acetaminophen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRAMADOL HYDROCHLORIDE	325 mg/1
ACETAMINOPHEN	37.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9N7R477WCK	Internal UNII lookup
362O9ITL9D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
836395	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
12f113b3-d6b1-a7b0-e063-6294a90a999d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
75d4bef7-334c-4a95-abb5-bff9def24114	Product name	2	20260112
43d017e1-6ae6-7555-71d1-c249236d6f26	Product name	4	20251117
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7f	Product name	5	20250115
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
88300afc-e1c4-ad17-c80b-4957f1b809a5	Product name	5	20250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043	Product name	7	20240611
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66f	Product name	1	20230808
a3631b20-02d1-41d7-8187-5e5e850b9e80	Product name	1	20230306
79e1734e-f721-4d46-978a-be382f771672	Product name	2	20230110
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
bff1fbab-f4cc-4993-b7de-2b555ee5eb73	Product name	1	20220509
92ead9ae-674d-4eee-a492-c385d496891f	Product name	3	20220308
c563c906-2606-457c-bb1b-5a623daed55b	Product name	1	20210511
103b151b-b17f-42ac-8624-3ef62f5e2975	Product name	2	20200507
b8497372-efe9-9dde-fa2d-59be9761aa64	Product name	9	20200428
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
43a9f8f9-34aa-8ae8-719e-5489454f7720	Product name	5	20200123
abd2f6f2-3fa7-4571-af8a-d67f89bdcb75	Product name	1	20190927
3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880	Product name	1	20190320
00d531e4-b130-8c52-eaf9-826cbb6f15dd	Product name	3	20190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659	Product name	9	20190205
22d922aa-c443-d9f3-b23c-03b03a9ad31c	Product name	7	20181220
377068df-225f-7318-a910-a1987cdfa361	Product name	3	20170608
23475c0b-a5b5-4fec-b97f-acca901eae6a	Product name	1	20140718
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
3ed6b849-48b8-8899-c288-6eeb396123b6	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
9457302e-0ca3-d9ff-0863-1b24b6107218	Product name	1	20140508
96c5169b-5b9d-547d-bf22-d688d91866e4	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
c8753a88-edde-8e17-a396-705537b52cee	Product name	1	20140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ce	Product name	1	20140508
cf3a804d-0326-aa22-0142-c184b5657d85	Product name	1	20140508
d5c49867-1fe9-7a44-3319-814417011d51	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-170-60	Tramadol Hydrochloride and Acetaminophen	60 in 1 BOTTLE	TABLET, FILM COATED	60		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-170	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1	Current NDC, 1 package rows	20240307_12f113b3-d6b1-a7b0-e063-6294a90a999d.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 ndc (product): 45865-170
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	12f113b3-d6b1-a7b0-e063-6294a90a999d	1
836395	acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet	SCD	12f113b3-d6b1-a7b0-e063-6294a90a999d	1
836395	APAP 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet	SY	12f113b3-d6b1-a7b0-e063-6294a90a999d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
45865-170-60	45865017060	60 TABLET, FILM COATED in 1 BOTTLE (45865-170-60)	2021-03-08	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tramadol Hydrochloride and Acetaminophen	Medsource Pharmaceuticals \| Aurobindo Pharma Limited	2024-03-05	HUMAN PRESCRIPTION DRUG LABEL	1