Tramadol Hydrochloride

Product NDC: 80425-0548
Requested package NDC: 80425-0548-5
11-digit product format: 804250548
Labeler code: 80425
Product ID: 80425-0548_4641b78d-bdc6-12d5-e063-6394a90a728a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tramadol Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Advanced Rx of Tennessee, LLC
Application: ANDA211825
Marketing category: ANDA
Marketing start: 2025-08-27
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: 2026-12-31
Current FDA listing: Yes

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
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.

Product history page 1 of 2 · 42 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	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A211825-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211825-001	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Tramadol Hydrochloride
Listing expiration: 2026-12-31

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
3d719560-7449-f970-e063-6294a90a9bd8	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80425-0548-1	Tramadol Hydrochloride	15 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	15	3
80425-0548-2	Tramadol Hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	3
80425-0548-3	Tramadol Hydrochloride	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60	3
80425-0548-4	Tramadol Hydrochloride	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90	3
80425-0548-5	Tramadol Hydrochloride	120 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	120	3
80425-0548-6	Tramadol Hydrochloride	40 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	40	3
80425-0548-7	Tramadol Hydrochloride	180 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	180	3
80425-0548-8	Tramadol Hydrochloride	240 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	240	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0548-1	EA - Each	80425-0548	bad65c76-d3f9-490b-97a4-175d3cf4e8ea	1	2025-10-14
80425-0548-2	EA - Each	80425-0548	81760d91-3fda-43a4-87af-12e9bb389f31	1	2025-10-14
80425-0548-3	EA - Each	80425-0548	39474083-7a93-412d-aaca-4997d711728f	1	2025-10-14
80425-0548-4	EA - Each	80425-0548	de095b93-e887-4eb2-aa18-f27ce88fc8eb	1	2025-10-14
80425-0548-5	EA - Each	80425-0548	0c4cab16-c419-4fbd-b834-3710053b29fb	1	2025-10-14
80425-0548-6	EA - Each	80425-0548	e248b839-4c7c-4281-bd75-adb0d7ba0d33	1	2025-10-14
80425-0548-7	EA - Each	80425-0548	d677fc0c-e3a1-4fde-91b1-b20c5356ac97	1	2025-10-14
80425-0548-8	EA - Each	80425-0548	341ea764-5f75-4740-843d-b09626eda492	1	2025-10-14

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
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 ndc (package): 80425-0548-5 ndc (product): 80425-0548 ndc11 (package): 80425054805
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	3d719560-7449-f970-e063-6294a90a9bd8	3
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	3d719560-7449-f970-e063-6294a90a9bd8	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
80425-0548-5	80425054805	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-5)	2025-08-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tramadol Hydrochloride - Advanced Rx of Tennessee, LLC	Advanced Rx of Tennessee, LLC	2025-12-18	HUMAN PRESCRIPTION DRUG LABEL	3