Tramadol Hydrochloride

Product NDC
72888-007
Requested package NDC
72888-007-05
11-digit product format
728880007
Labeler code
72888
Product ID
72888-007_bb58e11c-8a02-1cd1-e053-2a95a90afa56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Advagen Pharma Limited
Application
ANDA208708
Marketing category
ANDA
Marketing start
2020-09-01
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage72888-00772888-007-05DDiscontinued by firm2026-08-17

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208708-001TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-06-28
A208708-002TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE100MGTABLET / ORALABRS2019-06-28
A208708-003TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE25MGTABLET / ORALAB2023-11-27
A208708-004TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE75MGTABLET / ORAL2024-04-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208708-001AB
A208708-002AB
A208708-003AB

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 · 119 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A208708-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-06-28caaa826d4ba7…
2026-08-18 06:07:402026-07A208708-002TRAMADOL HYDROCHLORIDE100MGTABLET / ORALABRS2019-06-28caaa826d4ba7…
2026-08-18 06:07:402026-07A208708-003TRAMADOL HYDROCHLORIDE25MGTABLET / ORALAB2023-11-27caaa826d4ba7…
2026-08-18 06:07:402026-07A208708-004TRAMADOL HYDROCHLORIDE75MGTABLET / ORAL2024-04-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208708-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208708-002TRAMADOL HYDROCHLORIDE100MGTABLET / ORALABRS2019-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208708-003TRAMADOL HYDROCHLORIDE25MGTABLET / ORAL2023-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208708-004TRAMADOL HYDROCHLORIDE75MGTABLET / ORAL2024-04-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208708-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208708-002TRAMADOL HYDROCHLORIDE100MGTABLET / ORALABRS2019-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208708-003TRAMADOL HYDROCHLORIDE25MGTABLET / ORAL2023-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208708-004TRAMADOL HYDROCHLORIDE75MGTABLET / ORAL2024-04-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A208708-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208708-002TRAMADOL HYDROCHLORIDE100MGTABLET / ORALABRS2019-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208708-003TRAMADOL HYDROCHLORIDE25MGTABLET / ORAL2023-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208708-004TRAMADOL HYDROCHLORIDE75MGTABLET / ORAL2024-04-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208708-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208708-002TRAMADOL HYDROCHLORIDE100MGTABLET / ORALABRS2019-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208708-003TRAMADOL HYDROCHLORIDE25MGTABLET / ORAL2023-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208708-004TRAMADOL HYDROCHLORIDE75MGTABLET / ORAL2024-04-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208708-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208708-002TRAMADOL HYDROCHLORIDE100MGTABLET / ORALABRS2019-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208708-003TRAMADOL HYDROCHLORIDE25MGTABLET / ORAL2023-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208708-004TRAMADOL HYDROCHLORIDE75MGTABLET / ORAL2024-04-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208708-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-06-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208708-002TRAMADOL HYDROCHLORIDE100MGTABLET / ORALABRS2019-06-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208708-003TRAMADOL HYDROCHLORIDE25MGTABLET / ORAL2023-11-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208708-004TRAMADOL HYDROCHLORIDE75MGTABLET / ORAL2024-04-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208708-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-06-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208708-002TRAMADOL HYDROCHLORIDE100MGTABLET / ORALABRS2019-06-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208708-003TRAMADOL HYDROCHLORIDE25MGTABLET / ORAL2023-11-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208708-004TRAMADOL HYDROCHLORIDE75MGTABLET / ORAL2024-04-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208708-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-06-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208708-002TRAMADOL HYDROCHLORIDE100MGTABLET / ORALAB2019-06-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208708-003TRAMADOL HYDROCHLORIDE25MGTABLET / ORAL2023-11-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208708-004TRAMADOL HYDROCHLORIDE75MGTABLET / ORAL2024-04-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208708-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-06-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208708-002TRAMADOL HYDROCHLORIDE100MGTABLET / ORALAB2019-06-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208708-003TRAMADOL HYDROCHLORIDE25MGTABLET / ORAL2023-11-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208708-004TRAMADOL HYDROCHLORIDE75MGTABLET / ORAL2024-04-04d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A208708-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208708-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208708-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208708-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208708-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208708-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208708-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208708-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208708-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208708-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208708-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208708-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208708-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208708-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208708-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208708-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208708-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208708-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208708-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208708-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208708-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208708-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208708-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208708-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208708-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208708-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208708-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208708-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208708-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208708-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208708-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208708-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208708-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208708-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208708-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208708-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208708-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A208708-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208708-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A208708-002AB1782e0a99824c…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEREMEDYREPACK INC.9f0e33bd-65f8-446a-886f-e7e16a142ce52026-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208708
application number: ANDA208708
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDENorthwind Health Company, LLC552955e6-2bb3-8755-e063-6394a90ab21c2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208708
application number: ANDA208708
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEREMEDYREPACK INC.5199132e-745e-46a0-8068-e06d1bca5c612026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208708
application number: ANDA208708
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEBryant Ranch Prepack674803a0-4cf5-4416-a5e3-c1a1e332cdcd2026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208708
application number: ANDA208708
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAdvagen Pharma Limited93b12089-3a0f-4b57-abb1-2429cf31995d2026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208708
application number: ANDA208708
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDERedPharm Drug Incf4c148f3-845a-61e3-e053-2a95a90a326e2025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208708
application number: ANDA208708
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.84b12129-cf10-4a3e-889c-990ebabdece62025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208708
application number: ANDA208708
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEBryant Ranch Prepack2bf66203-8b45-475d-9a70-4d7c8bdfe6b32025-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208708
application number: ANDA208708
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAsclemed USA, Inc.6a60bd36-7dcc-49c3-b6de-b263fdaa312c2025-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208708
application number: ANDA208708
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDECoupler LLC3135a131-5f2d-3775-e063-6394a90a43222025-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208708
application number: ANDA208708
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDirectRxd5685c80-c84d-d0a1-e053-2995a90afc542025-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208708
application number: ANDA208708
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEProficient Rx LPd7e75fd3-18d1-4370-bb63-c9dd8a2c17192025-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208708
application number: ANDA208708
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf4ea18b0-2cbd-0d42-e053-2995a90a92642024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208708
application number: ANDA208708
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEQuality Care Products, LLCf79fda81-f09a-4a08-babc-6bd3bb3ee6612024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208708
application number: ANDA208708
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf44c53ec-26ea-d272-e053-2a95a90a5e592024-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208708
application number: ANDA208708
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDETRUPHARMA LLC61fb5ba7-6896-4ee4-83de-caee69b06a8e2021-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208708
application number: ANDA208708

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72888-007-0572888000705500 TABLET, COATED in 1 BOTTLE (72888-007-05) 2020-09-010000-00-00NoNoCurrent