Tramadol Hydrochloride and Acetaminophen

Product NDC: 68387-497
11-digit product format: 683870497
Labeler code: 68387
Product ID: 68387-497_daef6ebf-66a8-4909-90e1-20d39ed5ed20
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tramadol hydrochloride and acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Keltman Pharmaceuticals Inc.
Application: ANDA076475
Marketing category: ANDA
Marketing start: 2009-10-19
Marketing end: 0000-00-00
Substance: TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN
Active strength: 38 mg/1; mg/1
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68387-497		I	Inactivated by FDA	2026-10-05
excluded package	package	68387-497	68387-497-12	I	Inactivated by FDA	2026-10-05
excluded package	package	68387-497	68387-497-20	I	Inactivated by FDA	2026-10-05
excluded package	package	68387-497	68387-497-30	I	Inactivated by FDA	2026-10-05
excluded package	package	68387-497	68387-497-60	I	Inactivated by FDA	2026-10-05
excluded package	package	68387-497	68387-497-90	I	Inactivated by FDA	2026-10-05

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 3 · 132 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68387-497-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68387-497-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68387-497-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68387-497-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68387-497-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68387-497-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68387-497-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68387-497-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68387-497-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68387-497-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68387-497-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68387-497-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68387-497-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68387-497-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68387-497-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68387-497-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68387-497-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68387-497-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68387-497-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68387-497-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68387-497-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68387-497-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68387-497-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68387-497-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68387-497-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68387-497-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68387-497-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68387-497-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68387-497-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68387-497-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68387-497-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68387-497-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68387-497-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68387-497-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68387-497-20	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68387-497-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68387-497-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68387-497-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68387-497-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68387-497-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68387-497-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68387-497-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68387-497-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68387-497-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68387-497-20	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68387-497-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68387-497-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68387-497-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68387-497-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68387-497-20	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	325MG;37.5MG	TABLET / ORAL			2005-04-21

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 · 43 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
2026-09-14 22:38:34	2026-08	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2005-04-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2005-04-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2005-04-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076475-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2005-04-21	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076475-001	AB	1	`74a2ff9319b5…`
2019-09-15 20:21 UTC	2019-09	A076475-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076475-001	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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, Related label table
NDC	Related label
68387-497-12	Tramadol Hydrochloride and Acetaminophen Tablets 37.5 mg/325 mg
68387-497-20	Tramadol Hydrochloride and Acetaminophen Tablets 37.5 mg/325 mg
68387-497-30	Tramadol Hydrochloride and Acetaminophen Tablets 37.5 mg/325 mg
68387-497-60	Tramadol Hydrochloride and Acetaminophen Tablets 37.5 mg/325 mg
68387-497-90	Tramadol Hydrochloride and Acetaminophen Tablets 37.5 mg/325 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68387-497-12	Tramadol Hydrochloride and Acetaminophen	120 in 1 BOTTLE, PLASTIC	TABLET	120	2
68387-497-20	Tramadol Hydrochloride and Acetaminophen	20 in 1 BOTTLE, PLASTIC	TABLET	20	2
68387-497-30	Tramadol Hydrochloride and Acetaminophen	30 in 1 BOTTLE, PLASTIC	TABLET	30	2
68387-497-60	Tramadol Hydrochloride and Acetaminophen	60 in 1 BOTTLE, PLASTIC	TABLET	60	2
68387-497-90	Tramadol Hydrochloride and Acetaminophen	90 in 1 BOTTLE, PLASTIC	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
68387-497-12	EA - Each	68387-497	2248345a-95d9-4702-8695-a36371ca3145	1	2012-07-24
68387-497-20	EA - Each	68387-497	b241c430-0747-4f44-9304-6e44ce49df82	1	2012-07-24
68387-497-30	EA - Each	68387-497	90d67405-1a02-4683-8afb-3f9d3c9bf231	1	2012-07-24
68387-497-60	EA - Each	68387-497	5d356569-aa5f-455a-8e7c-bf7605c98877	1	2012-07-24
68387-497-90	EA - Each	68387-497	1418cb8c-dab7-4c9e-b33d-8cd07a722a6f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]	2
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]	2
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]	2
HYPROMELLOSE 2910 (3 CPS)	INACTIVE INGREDIENT	0VUT3PMY82	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]	2
HYPROMELLOSE 2910 (50 CPS)	INACTIVE INGREDIENT	1IVH67816N	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]	2
HYPROMELLOSE 2910 (6 CPS)	INACTIVE INGREDIENT	0WZ8WG20P6	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]	2
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]	2
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68387-497	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]	2	Legacy NDC, 5 package rows	20100908_80aaf81a-3447-4977-8902-03c62528a526.zip

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

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	80aaf81a-3447-4977-8902-03c62528a526	2
836395	acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet	SCD	80aaf81a-3447-4977-8902-03c62528a526	2
836395	APAP 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet	SY	80aaf81a-3447-4977-8902-03c62528a526	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68387-497-12	68387049712	120 in 1 BOTTLE, PLASTIC	Historical
68387-497-20	68387049720	20 in 1 BOTTLE, PLASTIC	Historical
68387-497-30	68387049730	30 in 1 BOTTLE, PLASTIC	Historical
68387-497-60	68387049760	60 in 1 BOTTLE, PLASTIC	Historical
68387-497-90	68387049790	90 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tramadol Hydrochloride and Acetaminophen Tablets 37.5 mg/325 mg	Keltman Pharmaceuticals Inc. \| Sandhills Packaging	2010-07-20	HUMAN PRESCRIPTION DRUG LABEL	2