Tramadol Hydrochloride

Product NDC: 71610-392
Requested package NDC: 71610-392-60
11-digit product format: 716100392
Labeler code: 71610
Product ID: 71610-392_9298ddb2-c8eb-4c15-aef0-a938e0975a3a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tramadol Hydrochloride
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA076003
Marketing category: ANDA
Marketing start: 2010-11-15
Marketing end: 0000-00-00
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: 2021-12-31
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	71610-392	71610-392-60	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 · 15 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…`

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
A076003-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076003-001	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	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`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	A076003-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076003-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076003-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076003-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076003-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076003-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076003-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076003-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076003-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076003-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076003-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076003-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076003-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076003-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076003-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076003-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076003-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076003-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076003-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076003-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076003-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076003-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076003-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076003-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076003-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076003-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076003-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076003-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076003-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076003-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076003-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076003-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076003-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076003-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076003-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076003-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076003-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076003-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076003-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076003-001	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, Related label table
NDC	Related label
71610-392-15	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-20	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-24	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-28	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-30	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-40	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-45	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-46	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-50	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-53	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-54	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-57	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-60	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-65	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-67	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-70	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-72	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-73	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-75	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-80	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-85	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-90	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-94	These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71610-392-15	Tramadol Hydrochloride	15 in 1 BOTTLE	TABLET, COATED	15	1
71610-392-20	Tramadol Hydrochloride	20 in 1 BOTTLE	TABLET, COATED	20	1
71610-392-24	Tramadol Hydrochloride	224 in 1 BOTTLE	TABLET, COATED	224	1
71610-392-28	Tramadol Hydrochloride	28 in 1 BOTTLE	TABLET, COATED	28	1
71610-392-30	Tramadol Hydrochloride	30 in 1 BOTTLE	TABLET, COATED	30	1
71610-392-40	Tramadol Hydrochloride	40 in 1 BOTTLE	TABLET, COATED	40	1
71610-392-45	Tramadol Hydrochloride	45 in 1 BOTTLE	TABLET, COATED	45	1
71610-392-46	Tramadol Hydrochloride	56 in 1 BOTTLE	TABLET, COATED	56	1
71610-392-50	Tramadol Hydrochloride	50 in 1 BOTTLE	TABLET, COATED	50	1
71610-392-53	Tramadol Hydrochloride	60 in 1 BOTTLE	TABLET, COATED	60	1
71610-392-54	Tramadol Hydrochloride	84 in 1 BOTTLE	TABLET, COATED	84	1
71610-392-57	Tramadol Hydrochloride	80 in 1 BOTTLE	TABLET, COATED	80	1
71610-392-60	Tramadol Hydrochloride	90 in 1 BOTTLE	TABLET, COATED	90	1
71610-392-65	Tramadol Hydrochloride	100 in 1 BOTTLE	TABLET, COATED	100	1
71610-392-67	Tramadol Hydrochloride	168 in 1 BOTTLE	TABLET, COATED	168	1
71610-392-70	Tramadol Hydrochloride	120 in 1 BOTTLE	TABLET, COATED	120	1
71610-392-72	Tramadol Hydrochloride	112 in 1 BOTTLE	TABLET, COATED	112	1
71610-392-73	Tramadol Hydrochloride	135 in 1 BOTTLE	TABLET, COATED	135	1
71610-392-75	Tramadol Hydrochloride	150 in 1 BOTTLE	TABLET, COATED	150	1
71610-392-80	Tramadol Hydrochloride	180 in 1 BOTTLE	TABLET, COATED	180	1
71610-392-85	Tramadol Hydrochloride	200 in 1 BOTTLE	TABLET, COATED	200	1
71610-392-90	Tramadol Hydrochloride	240 in 1 BOTTLE	TABLET, COATED	240	1
71610-392-94	Tramadol Hydrochloride	360 in 1 BOTTLE	TABLET, COATED	360	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-392-15	EA - Each	71610-392	08c80734-b411-47e1-80a7-24e80fdb6a7c	1	2020-04-20
71610-392-20	EA - Each	71610-392	b4243d4c-0751-4aa7-81cf-55b2549ded8c	1	2020-04-20
71610-392-24	EA - Each	71610-392	ba41f1ee-c205-48c3-bdf6-34e92317bbc0	1	2020-04-20
71610-392-28	EA - Each	71610-392	343b79ff-d050-4bdf-a63b-aeb7e76b80d6	1	2020-04-20
71610-392-30	EA - Each	71610-392	ca6d54ea-1f33-452d-b1fc-4d705df90b61	1	2020-04-20
71610-392-40	EA - Each	71610-392	1a78911b-5f35-4837-bc0b-491bd7e2daab	1	2020-04-20
71610-392-45	EA - Each	71610-392	1a8c1b16-ecc9-47fd-aee6-442b6bf790be	1	2020-04-20
71610-392-46	EA - Each	71610-392	18fce50b-b3e2-4e1d-8dba-475219d34a4a	1	2020-04-20
71610-392-50	EA - Each	71610-392	a055afdd-ddec-45d0-9acd-eba1278097b0	1	2020-04-20
71610-392-53	EA - Each	71610-392	65fef699-a636-4ba8-923f-d22c5198be09	1	2020-04-20
71610-392-54	EA - Each	71610-392	ed3f3e7a-c38a-44f4-907d-f0287313e307	1	2020-04-20
71610-392-57	EA - Each	71610-392	665d0271-9600-4fbf-9413-bf7592621b52	1	2020-04-20
71610-392-60	EA - Each	71610-392	f172918b-2cf0-4be8-a69d-82e491f4ebaa	1	2020-04-20
71610-392-65	EA - Each	71610-392	c45dfd15-a186-4381-a613-c681f6f220a0	1	2020-04-20
71610-392-67	EA - Each	71610-392	f3f03428-684a-4a47-96d6-b37ad27ff1d7	1	2020-04-20
71610-392-70	EA - Each	71610-392	54194161-2951-4a1a-8402-f4ccd4c51667	1	2020-04-20
71610-392-72	EA - Each	71610-392	8cefaf5c-cf14-44fe-a3ca-e3694ae8be7d	1	2020-04-20
71610-392-73	EA - Each	71610-392	f23ad638-6fcf-4c7d-b21b-53aa4cfecaf1	1	2020-04-20
71610-392-75	EA - Each	71610-392	81a3c8a8-60da-418d-9033-73f1cc0b7ca5	1	2020-04-20
71610-392-85	EA - Each	71610-392	0f341891-9af0-48d8-9017-70a9bdb477b9	1	2020-04-20
71610-392-90	EA - Each	71610-392	47147a3d-42d5-41ae-bfb5-0ec0e591ac0a	1	2020-04-20
71610-392-94	EA - Each	71610-392	89204240-9d23-4150-978d-2f9cc3776e34	1	2020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-392	TRAMADOL HYDROCHLORIDE TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC, 23 package rows	20200303_ac0b0590-e280-4d20-8238-61e7d4b0d2f3.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Coupler LLC	54d74939-301b-e603-e063-6394a90a3b03	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Major Pharmaceuticals	6b0b95b2-ae4c-42e8-9f2e-bcdaffda62e2	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	67919c2c-2f8a-4bbb-bef5-0cd6c1e63a16	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	8ec4e4e5-a56e-4198-8428-6b770b9bf27d	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	American Health Packaging	f6f6069b-cc75-4b87-afa5-b83001b543e0	2025-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	2e738ced-9cde-e776-e063-6294a90a7e33	2025-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Clinical Solutions Wholesale, LLC	728157e2-d153-4ea0-81eb-36599dc7dfda	2025-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	5babcfcf-331b-5db9-e053-2a91aa0aaf89	2025-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol HCL	TRAMADOL HCL	Advanced Rx of Tennessee, LLC	af87fc31-07c2-b1f7-e053-2995a90a499f	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Amneal Pharmaceuticals LLC	58b802cb-2443-4f5b-9718-7d54c6d50cb4	2021-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	50f4b752-20af-4ebf-9408-e78f30d2a3cc	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003

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	ac0b0590-e280-4d20-8238-61e7d4b0d2f3	1
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	ac0b0590-e280-4d20-8238-61e7d4b0d2f3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-392-60	71610039260	90 TABLET, COATED in 1 BOTTLE (71610-392-60)	2020-01-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tramadol Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	2020-02-19	HUMAN PRESCRIPTION DRUG LABEL	1