Tramadol Hydrochloride

Product NDC: 50090-5789
Requested package NDC: 50090-5789-3
11-digit product format: 500905789
Labeler code: 50090
Product ID: 50090-5789_d2130333-f392-4f3c-b988-c4147c6c9595
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tramadol Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA211825
Marketing category: ANDA
Marketing start: 2019-08-09
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: 2027-12-31
Current FDA listing: Yes

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	50090-5789	50090-5789-3	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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-5789	50090-5789-3	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
A211825-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2019-08-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211825-001	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.

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	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211825-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211825-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211825-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211825-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211825-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211825-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211825-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211825-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211825-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211825-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211825-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211825-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211825-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211825-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211825-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211825-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211825-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211825-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211825-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211825-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211825-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211825-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211825-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211825-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211825-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211825-001	AB	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211825-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211825-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211825-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211825-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211825-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211825-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211825-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211825-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211825-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211825-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211825-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211825-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211825-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211825-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Tramadol Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRAMADOL HYDROCHLORIDE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
835603	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f9282800-fde7-477a-8b8f-59617ec26f73	Available on FDA.report

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
50090-5789-0	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.
50090-5789-1	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.
50090-5789-2	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.
50090-5789-3	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.
50090-5789-4	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.
50090-5789-5	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.
50090-5789-9	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.
50090-5789-0	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.
50090-5789-1	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.
50090-5789-2	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.
50090-5789-3	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.
50090-5789-4	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.
50090-5789-5	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.
50090-5789-9	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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-5789-0	Tramadol Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	13
50090-5789-1	Tramadol Hydrochloride	20 in 1 BOTTLE	TABLET, FILM COATED	20	13
50090-5789-2	Tramadol Hydrochloride	50 in 1 BOTTLE	TABLET, FILM COATED	50	13
50090-5789-3	Tramadol Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100	13
50090-5789-4	Tramadol Hydrochloride	15 in 1 BOTTLE	TABLET, FILM COATED	15	13
50090-5789-5	Tramadol Hydrochloride	60 in 1 BOTTLE	TABLET, FILM COATED	60	13
50090-5789-9	Tramadol Hydrochloride	120 in 1 BOTTLE	TABLET, FILM COATED	120	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5789-0	EA - Each	50090-5789	37f07a63-37d5-4c5f-9bc0-95644d69b73a	1	2022-10-06
50090-5789-1	EA - Each	50090-5789	20923d6a-9088-4f81-94ab-3be7f5bebff7	1	2022-10-06
50090-5789-2	EA - Each	50090-5789	fba9c6e6-f7dd-4d3c-9658-abc36f9af3a4	1	2022-10-06
50090-5789-3	EA - Each	50090-5789	27dfbf5c-2b1c-46c1-bc48-4b1b2249c55d	1	2022-10-06
50090-5789-4	EA - Each	50090-5789	a8d3802a-40fe-490c-874b-88aa03159e35	1	2022-10-06
50090-5789-5	EA - Each	50090-5789	f74fefe0-2b3f-4545-a2e8-7af9b417dab1	1	2022-10-06
50090-5789-9	EA - Each	50090-5789	7d882d50-5272-46a8-821f-92dcd3e12f74	1	2022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5789	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	7	Current NDC, Legacy NDC, 7 package rows	20240604_f9282800-fde7-477a-8b8f-59617ec26f73.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 Hydrochloride	TRAMADOL HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	007bf37f-0e46-426a-ac8c-be63d4b7414c	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211825 application number: ANDA211825
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	A-S Medication Solutions	4a525cf7-2c0c-47c6-aed3-3a395a7120ec	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211825 application number: ANDA211825
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	A-S Medication Solutions	f9282800-fde7-477a-8b8f-59617ec26f73	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211825 application number: ANDA211825 ndc (package): 50090-5789-3 ndc (product): 50090-5789 ndc11 (package): 50090578903
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Asclemed USA, Inc.	18d9e3e4-5892-43b8-b211-3ef3393ad946	2026-02-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211825 application number: ANDA211825
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	3d719560-7449-f970-e063-6294a90a9bd8	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211825 application number: ANDA211825
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	f558c59c-cbd4-4b17-9a3d-b014ad09bbb1	2025-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211825 application number: ANDA211825
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	e6e275c3-1e16-4a00-b7fd-608ae6cbd515	2025-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211825 application number: ANDA211825

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	f9282800-fde7-477a-8b8f-59617ec26f73	13
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	f9282800-fde7-477a-8b8f-59617ec26f73	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5789-3	50090578903	100 TABLET, FILM COATED in 1 BOTTLE (50090-5789-3)	2021-10-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tramadol Hydrochloride - A-S Medication Solutions	A-S Medication Solutions	2026-02-17	HUMAN PRESCRIPTION DRUG LABEL	13