TRAMADOL HYDROCHLORIDE

Product NDC: 72189-311
Requested package NDC: 72189-311-60
11-digit product format: 721890311
Labeler code: 72189
Product ID: 72189-311_2c3cf1d7-38f5-4d25-e063-6294a90aa8cd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TRAMADOL HYDROCHLORIDE
Dosage form: TABLET, COATED
Route: ORAL
Labeler: DirectRx
Application: ANDA208708
Marketing category: ANDA
Marketing start: 2022-01-12
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

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 · 2 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
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-311	72189-311-60	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-311	72189-311-60	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208708-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2019-06-28
A208708-002	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2019-06-28
A208708-003	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2023-11-27
A208708-004	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	75MG	TABLET / ORAL			2024-04-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A208708-001	AB
A208708-002	AB
A208708-003	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 3 · 115 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	A208708-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208708-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208708-003	TRAMADOL HYDROCHLORIDE	25MG	TABLET / ORAL			2023-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208708-004	TRAMADOL HYDROCHLORIDE	75MG	TABLET / ORAL			2024-04-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208708-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2019-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208708-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2019-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208708-003	TRAMADOL HYDROCHLORIDE	25MG	TABLET / ORAL			2023-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208708-004	TRAMADOL HYDROCHLORIDE	75MG	TABLET / ORAL			2024-04-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208708-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2019-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208708-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2019-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208708-003	TRAMADOL HYDROCHLORIDE	25MG	TABLET / ORAL			2023-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208708-004	TRAMADOL HYDROCHLORIDE	75MG	TABLET / ORAL			2024-04-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208708-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2019-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208708-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2019-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208708-003	TRAMADOL HYDROCHLORIDE	25MG	TABLET / ORAL			2023-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208708-004	TRAMADOL HYDROCHLORIDE	75MG	TABLET / ORAL			2024-04-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208708-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2019-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208708-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2019-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208708-003	TRAMADOL HYDROCHLORIDE	25MG	TABLET / ORAL			2023-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208708-004	TRAMADOL HYDROCHLORIDE	75MG	TABLET / ORAL			2024-04-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208708-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2019-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208708-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2019-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208708-003	TRAMADOL HYDROCHLORIDE	25MG	TABLET / ORAL			2023-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208708-004	TRAMADOL HYDROCHLORIDE	75MG	TABLET / ORAL			2024-04-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208708-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2019-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208708-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2019-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208708-003	TRAMADOL HYDROCHLORIDE	25MG	TABLET / ORAL			2023-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208708-004	TRAMADOL HYDROCHLORIDE	75MG	TABLET / ORAL			2024-04-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208708-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2019-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208708-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2019-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208708-003	TRAMADOL HYDROCHLORIDE	25MG	TABLET / ORAL			2023-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208708-004	TRAMADOL HYDROCHLORIDE	75MG	TABLET / ORAL			2024-04-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208708-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2019-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208708-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2019-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208708-003	TRAMADOL HYDROCHLORIDE	25MG	TABLET / ORAL			2023-11-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208708-004	TRAMADOL HYDROCHLORIDE	75MG	TABLET / ORAL			2024-04-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208708-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2019-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208708-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2019-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208708-003	TRAMADOL HYDROCHLORIDE	25MG	TABLET / ORAL			2023-11-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208708-004	TRAMADOL HYDROCHLORIDE	75MG	TABLET / ORAL			2024-04-04	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 71 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	A208708-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208708-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208708-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208708-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208708-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208708-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208708-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208708-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208708-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208708-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208708-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208708-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208708-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208708-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208708-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208708-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208708-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208708-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208708-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208708-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208708-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208708-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208708-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208708-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208708-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208708-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208708-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208708-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208708-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208708-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208708-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208708-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208708-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208708-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208708-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208708-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208708-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208708-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208708-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208708-001	AB	1	`5aa47cf7b7d7…`

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
d5685c80-c84d-d0a1-e053-2995a90afc54	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
72189-311-12	TRAMADOL HYDROCHLORIDE	12 in 1 BOTTLE	TABLET, COATED	12	6
72189-311-20	TRAMADOL HYDROCHLORIDE	20 in 1 BOTTLE	TABLET, COATED	20	6
72189-311-30	TRAMADOL HYDROCHLORIDE	30 in 1 BOTTLE	TABLET, COATED	30	6
72189-311-40	TRAMADOL HYDROCHLORIDE	40 in 1 BOTTLE	TABLET, COATED	40	6
72189-311-60	TRAMADOL HYDROCHLORIDE	60 in 1 BOTTLE	TABLET, COATED	60	6
72189-311-72	TRAMADOL HYDROCHLORIDE	120 in 1 BOTTLE	TABLET, COATED	120	6
72189-311-82	TRAMADOL HYDROCHLORIDE	180 in 1 BOTTLE	TABLET, COATED	180	6
72189-311-84	TRAMADOL HYDROCHLORIDE	240 in 1 BOTTLE	TABLET, COATED	240	6
72189-311-90	TRAMADOL HYDROCHLORIDE	90 in 1 BOTTLE	TABLET, COATED	90	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-311-12	EA - Each	72189-311	bb4b8613-7018-4939-abd7-46dbde87894a	1	2022-03-09
72189-311-20	EA - Each	72189-311	a4935974-0877-4d13-add3-c45b00a70c95	1	2022-03-09
72189-311-30	EA - Each	72189-311	881ce719-6dea-4584-9f03-bfd8ee519c73	1	2022-03-09
72189-311-40	EA - Each	72189-311	456ab373-4be4-4923-aead-606df12772f3	1	2022-03-09
72189-311-60	EA - Each	72189-311	fc32e5f9-dd7e-406b-8c83-bc45c19513db	1	2022-02-07
72189-311-72	EA - Each	72189-311	79301120-5975-4799-b806-cc931c8fff2b	1	2022-02-07
72189-311-82	EA - Each	72189-311	049f3c07-4670-40d3-8cda-5b687e9f38dd	1	2022-03-09
72189-311-84	EA - Each	72189-311	51cd3aa0-05cf-4104-972a-9df40d9cad81	1	2023-08-08
72189-311-90	EA - Each	72189-311	f6f7bf27-00fe-402b-8145-e9bcf9a307fd	1	2022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-311	TRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECTRX]	6	Current NDC, Legacy NDC, 9 package rows	20250122_d5685c80-c84d-d0a1-e053-2995a90afc54.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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	9f0e33bd-65f8-446a-886f-e7e16a142ce5	2026-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208708 application number: ANDA208708
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Northwind Health Company, LLC	552955e6-2bb3-8755-e063-6394a90ab21c	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208708 application number: ANDA208708
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	5199132e-745e-46a0-8068-e06d1bca5c61	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208708 application number: ANDA208708
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	674803a0-4cf5-4416-a5e3-c1a1e332cdcd	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208708 application number: ANDA208708
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Advagen Pharma Limited	93b12089-3a0f-4b57-abb1-2429cf31995d	2026-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208708 application number: ANDA208708
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	RedPharm Drug Inc	f4c148f3-845a-61e3-e053-2a95a90a326e	2025-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208708 application number: ANDA208708
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	84b12129-cf10-4a3e-889c-990ebabdece6	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208708 application number: ANDA208708
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	2bf66203-8b45-475d-9a70-4d7c8bdfe6b3	2025-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208708 application number: ANDA208708
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Asclemed USA, Inc.	6a60bd36-7dcc-49c3-b6de-b263fdaa312c	2025-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208708 application number: ANDA208708
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Coupler LLC	3135a131-5f2d-3775-e063-6394a90a4322	2025-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208708 application number: ANDA208708
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DirectRx	d5685c80-c84d-d0a1-e053-2995a90afc54	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208708 application number: ANDA208708 ndc (package): 72189-311-60 ndc (product): 72189-311 ndc11 (package): 72189031160
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	d7e75fd3-18d1-4370-bb63-c9dd8a2c1719	2025-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208708 application number: ANDA208708
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f4ea18b0-2cbd-0d42-e053-2995a90a9264	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208708 application number: ANDA208708
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Quality Care Products, LLC	f79fda81-f09a-4a08-babc-6bd3bb3ee661	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208708 application number: ANDA208708
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f44c53ec-26ea-d272-e053-2a95a90a5e59	2024-09-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208708 application number: ANDA208708
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	TRUPHARMA LLC	61fb5ba7-6896-4ee4-83de-caee69b06a8e	2021-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208708 application number: ANDA208708

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	d5685c80-c84d-d0a1-e053-2995a90afc54	6
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	d5685c80-c84d-d0a1-e053-2995a90afc54	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-311-60	72189031160	60 TABLET, COATED in 1 BOTTLE (72189-311-60)	2022-01-12	0000-00-00	No	No	Current