tramadol hydrochloride

Product NDC: 50090-0806
11-digit product format: 500900806
Labeler code: 50090
Product ID: 50090-0806_ce994d33-5ce0-4b1a-a1eb-fcb49234b6c3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tramadol hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA075964
Marketing category: ANDA
Marketing start: 2002-06-22
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: 2022-12-31
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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50090-0806		D	Discontinued by firm	2026-08-07
excluded package	package	50090-0806	50090-0806-0	D	Discontinued by firm	2026-08-07
excluded package	package	50090-0806	50090-0806-1	D	Discontinued by firm	2026-08-07
excluded package	package	50090-0806	50090-0806-2	D	Discontinued by firm	2026-08-07
excluded package	package	50090-0806	50090-0806-3	D	Discontinued by firm	2026-08-07
excluded package	package	50090-0806	50090-0806-4	D	Discontinued by firm	2026-08-07
excluded package	package	50090-0806	50090-0806-5	D	Discontinued by firm	2026-08-07
excluded package	package	50090-0806	50090-0806-7	D	Discontinued by firm	2026-08-07
excluded package	package	50090-0806	50090-0806-9	D	Discontinued by firm	2026-08-07

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 · 17 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	50090-0806-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-0806-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-0806-7	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-0806-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-0806-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-0806-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-0806-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-0806-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-0806-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-0806-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-0806-7	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-0806-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-0806-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-0806-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-0806-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-0806-1	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A075964-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075964-001	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	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`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	A075964-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075964-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075964-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075964-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075964-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075964-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075964-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075964-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075964-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075964-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075964-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075964-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075964-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075964-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075964-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075964-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075964-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075964-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075964-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075964-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075964-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075964-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075964-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075964-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075964-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075964-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075964-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075964-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075964-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075964-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075964-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075964-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075964-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075964-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075964-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075964-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075964-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075964-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075964-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075964-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
43d017e1-6ae6-7555-71d1-c249236d6f26	Product name	4	20251117
bff1fbab-f4cc-4993-b7de-2b555ee5eb73	Product name	1	20220509
c563c906-2606-457c-bb1b-5a623daed55b	Product name	1	20210511
43a9f8f9-34aa-8ae8-719e-5489454f7720	Product name	5	20200123
abd2f6f2-3fa7-4571-af8a-d67f89bdcb75	Product name	1	20190927
377068df-225f-7318-a910-a1987cdfa361	Product name	3	20170608
9457302e-0ca3-d9ff-0863-1b24b6107218	Product name	1	20140508
d5c49867-1fe9-7a44-3319-814417011d51	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-0806-0	2023-02-07	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
50090-0806-1	2023-02-07	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
50090-0806-2	2023-02-07	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
50090-0806-3	2023-02-07	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
50090-0806-4	2023-02-07	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
50090-0806-5	2023-02-07	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
50090-0806-7	2023-02-07	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
50090-0806-9	2023-02-07	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
50090-0806-0	2023-01-30	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
50090-0806-1	2023-01-30	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
50090-0806-2	2023-01-30	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
50090-0806-3	2023-01-30	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
50090-0806-4	2023-01-30	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
50090-0806-5	2023-01-30	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
50090-0806-7	2023-01-30	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
50090-0806-9	2023-01-30	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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-0806-0	EA - Each	50090-0806	b09cd67d-3662-4a36-944d-180040d39818	1	2018-10-11
50090-0806-1	EA - Each	50090-0806	705cff09-37c6-46e7-9bcd-2d91c88c2c05	1	2018-10-11
50090-0806-2	EA - Each	50090-0806	02818a1a-66d3-4679-a693-6997828bf710	1	2018-10-11
50090-0806-3	EA - Each	50090-0806	c3a44cae-d31e-46b8-9dc0-f552e7dfb78a	1	2018-10-11
50090-0806-4	EA - Each	50090-0806	20c17dcb-a077-498f-9b28-d07fa10f8954	1	2018-10-11
50090-0806-5	EA - Each	50090-0806	9a5c5283-847b-41a7-b925-bbd51cce192f	1	2018-10-11
50090-0806-9	EA - Each	50090-0806	b45cf1f4-8516-4742-b068-1940e60c137c	1	2018-10-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-0806	TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]	21	Legacy NDC	20250406_08205443-f1db-4019-a95c-8b5025df0ae0.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9N7R477WCK	TRAMADOL HYDROCHLORIDE	36282-47-0	TRAMADOL HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-0806-0	50090080600	30 TABLET in 1 BOTTLE (50090-0806-0)	30 tablet	2014-11-28	0000-00-00	No	No	Current
50090-0806-1	50090080601	20 TABLET in 1 BOTTLE (50090-0806-1)	20 tablet	2014-11-28	0000-00-00	No	No	Current
50090-0806-2	50090080602	50 TABLET in 1 BOTTLE (50090-0806-2)	50 tablet	2014-11-28	0000-00-00	No	No	Current
50090-0806-3	50090080603	100 TABLET in 1 BOTTLE (50090-0806-3)	100 tablet	2014-11-28	0000-00-00	No	No	Current
50090-0806-4	50090080604	15 TABLET in 1 BOTTLE (50090-0806-4)	15 tablet	2014-11-28	0000-00-00	No	No	Current
50090-0806-5	50090080605	60 TABLET in 1 BOTTLE (50090-0806-5)	60 tablet	2014-11-28	0000-00-00	No	No	Current
50090-0806-7	50090080607	45 TABLET in 1 BOTTLE (50090-0806-7)	45 tablet	2014-08-15	0000-00-00	No	No	Current
50090-0806-9	50090080609	120 TABLET in 1 BOTTLE (50090-0806-9)	120 tablet	2014-11-28	0000-00-00	No	No	Current