Tramadol Hydrochloride

Product NDC
67046-1541
11-digit product format
670461541
Labeler code
67046
Product ID
67046-1541_3135a0e3-6e29-4091-e063-6394a90a52cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Coupler LLC
Application
ANDA208708
Marketing category
ANDA
Marketing start
2025-03-25
Substance
TRAMADOL HYDROCHLORIDE
Active strength
100 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 1.

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 · 115 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-10-29 15:01 UTC2024-10A208708-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-06-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A208708-002TRAMADOL HYDROCHLORIDE100MGTABLET / ORALAB2019-06-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A208708-003TRAMADOL HYDROCHLORIDE25MGTABLET / ORAL2023-11-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A208708-004TRAMADOL HYDROCHLORIDE75MGTABLET / ORAL2024-04-04d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 71 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208708-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208708-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A208708-001AB15aa47cf7b7d7…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAMADOL HYDROCHLORIDE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9N7R477WCKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2179635Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3135a131-5f2d-3775-e063-6394a90a4322Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
43d017e1-6ae6-7555-71d1-c249236d6f26Product name420251117
bff1fbab-f4cc-4993-b7de-2b555ee5eb73Product name120220509
c563c906-2606-457c-bb1b-5a623daed55bProduct name120210511
43a9f8f9-34aa-8ae8-719e-5489454f7720Product name520200123
abd2f6f2-3fa7-4571-af8a-d67f89bdcb75Product name120190927
377068df-225f-7318-a910-a1987cdfa361Product name320170608
9457302e-0ca3-d9ff-0863-1b24b6107218Product name120140508
d5c49867-1fe9-7a44-3319-814417011d51Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-1541-3Tramadol Hydrochloride30 in 1 BLISTER PACKTABLET, COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-1541TRAMADOL HYDROCHLORIDE TABLET, COATED [COUPLER LLC]1Current NDC, 1 package rows20250327_3135a131-5f2d-3775-e063-6394a90a4322.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEREMEDYREPACK INC.9f0e33bd-65f8-446a-886f-e7e16a142ce52026-07-30Boxed 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
ndc (product): 67046-1541
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2179635traMADol HCl 100 MG Oral TabletPSN3135a131-5f2d-3775-e063-6394a90a43221
2179635tramadol hydrochloride 100 MG Oral TabletSCD3135a131-5f2d-3775-e063-6394a90a43221
2179635tramadol HCl 100 MG Oral TabletSY3135a131-5f2d-3775-e063-6394a90a43221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67046-1541-36704615410330 TABLET, COATED in 1 BLISTER PACK (67046-1541-3) 2025-03-25NoNoCurrent