Tramadol Hydrochloride and Acetaminophen

Product NDC: 63629-4901
Requested package NDC: 63629-4901-2
11-digit product format: 636294901
Labeler code: 63629
Product ID: 63629-4901_28f41a8b-d23d-4c6b-9c0e-340a338a86da
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tramadol Hydrochloride and Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA090485
Marketing category: ANDA
Marketing start: 2009-12-17
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63629-4901	63629-4901-2	D	Discontinued by firm		2026-08-11

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 · 19 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…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2021-12-27 23:28 UTC · source 2021-12-27	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	`110d247fa046…`	`a55b01930146…`

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
A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090485-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	RS	2009-12-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090485-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB		2009-12-09	`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	A090485-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090485-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090485-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090485-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090485-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090485-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090485-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090485-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090485-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090485-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090485-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090485-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090485-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090485-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090485-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090485-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090485-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090485-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090485-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090485-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090485-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090485-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090485-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090485-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090485-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090485-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090485-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090485-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090485-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090485-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090485-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090485-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090485-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090485-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090485-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090485-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090485-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090485-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090485-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090485-001	AB	1	`cb3db0bc1861…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-4901-1	2024-01-30	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, C-IV Initial U.S. Approval: 2001
63629-4901-2	2024-01-30	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, C-IV Initial U.S. Approval: 2001
63629-4901-3	2024-01-30	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, C-IV Initial U.S. Approval: 2001
63629-4901-4	2024-01-30	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, C-IV Initial U.S. Approval: 2001
63629-4901-5	2024-01-30	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, C-IV Initial U.S. Approval: 2001
63629-4901-6	2024-01-30	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, C-IV Initial U.S. Approval: 2001
63629-4901-7	2024-01-30	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, C-IV Initial U.S. Approval: 2001
63629-4901-8	2024-01-30	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, C-IV Initial U.S. Approval: 2001
63629-4901-1	2022-02-16	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, C-IV Initial U.S. Approval: 2001
63629-4901-2	2022-02-16	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, C-IV Initial U.S. Approval: 2001
63629-4901-3	2022-02-16	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, C-IV Initial U.S. Approval: 2001
63629-4901-4	2022-02-16	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, C-IV Initial U.S. Approval: 2001
63629-4901-5	2022-02-16	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, C-IV Initial U.S. Approval: 2001
63629-4901-1	2019-11-27	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, C-IV Initial U.S. Approval: 2001
63629-4901-2	2019-11-27	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, C-IV Initial U.S. Approval: 2001
63629-4901-3	2019-11-27	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, C-IV Initial U.S. Approval: 2001
63629-4901-4	2019-11-27	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, C-IV Initial U.S. Approval: 2001
63629-4901-5	2019-11-27	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, C-IV Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63629-4901-1	Tramadol Hydrochloride and Acetaminophen	30 in 1 BOTTLE	TABLET	30	1002
63629-4901-2	Tramadol Hydrochloride and Acetaminophen	60 in 1 BOTTLE	TABLET	60	1002
63629-4901-3	Tramadol Hydrochloride and Acetaminophen	90 in 1 BOTTLE	TABLET	90	1002
63629-4901-4	Tramadol Hydrochloride and Acetaminophen	120 in 1 BOTTLE	TABLET	120	1002
63629-4901-5	Tramadol Hydrochloride and Acetaminophen	20 in 1 BOTTLE	TABLET	20	1002
63629-4901-6	Tramadol Hydrochloride and Acetaminophen	40 in 1 BOTTLE	TABLET	40	1002
63629-4901-7	Tramadol Hydrochloride and Acetaminophen	100 in 1 BOTTLE	TABLET	100	1002
63629-4901-8	Tramadol Hydrochloride and Acetaminophen	15 in 1 BOTTLE	TABLET	15	1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-4901-1	EA - Each	63629-4901	74af0e3d-af8b-4778-b067-98ff329b4510	1	2015-10-02
63629-4901-2	EA - Each	63629-4901	cb708aba-fd94-407b-b2cc-71d1ca35fe43	1	2015-10-02
63629-4901-3	EA - Each	63629-4901	a697df0b-6c77-4bb5-8443-69598d0c2c9c	1	2015-10-02
63629-4901-4	EA - Each	63629-4901	daadb2a6-ad99-48ad-b48d-306af82646fb	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-4901	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1002	Legacy NDC, 8 package rows	20220217_28f41a8b-d23d-4c6b-9c0e-340a338a86da.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tramadol/APAP	TRAMADOL/APAP	Direct_rx	4e40f55e-1d8e-ce2f-e063-6294a90a7bec	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090485 application number: ANDA090485
Tramadol Hydrochloride and Acetaminophen	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	AvPAK	244f6e5d-e1b4-ba8b-ca6f-af2d8a31d5f0	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090485 application number: ANDA090485
Tramadol Hydrochloride and Acetaminophen	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Amneal Pharmaceuticals of New York LLC	d51600e2-2f73-483c-9b2e-f142bafff16d	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090485 application number: ANDA090485
Tramadol Hydrochloride and Acetaminophen	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Preferred Pharmaceuticals Inc.	96094578-5348-4955-8e91-1c9163315d5a	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090485 application number: ANDA090485
Tramadol Hydrochloride and Acetaminophen	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Bryant Ranch Prepack	f33fcd05-2c95-48dd-884b-5ed9c25c2ccf	2024-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090485 application number: ANDA090485
Tramadol Hydrochloride and Acetaminophen	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Asclemed USA, Inc.	52693021-f60f-43bc-9b05-43db18621346	2022-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090485 application number: ANDA090485
Tramadol Hydrochloride and Acetaminophen	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Proficient Rx LP	1ad89537-3e59-438c-b646-b3c93b790853	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090485 application number: ANDA090485

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	28f41a8b-d23d-4c6b-9c0e-340a338a86da	1002
836395	acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet	SCD	28f41a8b-d23d-4c6b-9c0e-340a338a86da	1002
836395	APAP 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet	SY	28f41a8b-d23d-4c6b-9c0e-340a338a86da	1002

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-4901-2	63629490102	60 TABLET in 1 BOTTLE (63629-4901-2)	60 tablet	2013-08-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tramadol Hydrochloride and Acetaminophen	Bryant Ranch Prepack	2022-02-15	HUMAN PRESCRIPTION DRUG LABEL	1002