Tramadol Hydrochloride and Acetaminophen

Product NDC
72189-382
Requested package NDC
72189-382-60
11-digit product format
721890382
Labeler code
72189
Product ID
72189-382_2c4cd58a-0293-714d-e063-6394a90a5edd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride and Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA207152
Marketing category
ANDA
Marketing start
2022-09-14
Substance
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Active strength
325; 37.5 mg/1; 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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72189-38272189-382-60UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-38272189-382-60UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENACETAMINOPHEN; TRAMADOL HYDROCHLORIDE325MG;37.5MGTABLET / ORALAB2017-03-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207152-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-223f01610625f2…
2019-09-15 20:21 UTC2019-09A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207152-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2017-03-22cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207152-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207152-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207152-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207152-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207152-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207152-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207152-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207152-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207152-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207152-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207152-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207152-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207152-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207152-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207152-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207152-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207152-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207152-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207152-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207152-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207152-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A207152-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207152-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207152-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207152-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A207152-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207152-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207152-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207152-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207152-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207152-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207152-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207152-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207152-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207152-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207152-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207152-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207152-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207152-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207152-001AB1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
TRAMADOL HYDROCHLORIDE37.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
9N7R477WCKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
836395Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e8a7c995-e473-ca87-e053-2995a90a5b80Available 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
72189-382-60Tramadol Hydrochloride and Acetaminophen60 in 1 BOTTLETABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-382-60EA - Each72189-382fd089fda-1e82-4e5c-a583-a26bba4cb2ba12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-382TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [DIRECT_RX]2Current NDC, Legacy NDC, 1 package rows20250123_e8a7c995-e473-ca87-e053-2995a90a5b80.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacycb05d615-918d-8104-e053-2995a90aa96b2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207152
application number: ANDA207152
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENBryant Ranch Prepackccf465b5-8ef8-4445-a0d4-23b5cf13188c2026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207152
application number: ANDA207152
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENBryant Ranch Prepackc83366d9-db60-45eb-9c2b-a2c58d45c82c2026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207152
application number: ANDA207152
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENAurobindo Pharma Limited6c2894df-eeeb-4b22-ab32-8ce1601bfdfa2025-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207152
application number: ANDA207152
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENREMEDYREPACK INC.5058c2b0-5c66-4cd2-80a6-7a4678c1fd512025-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207152
application number: ANDA207152
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENDirect_Rxe8a7c995-e473-ca87-e053-2995a90a5b802025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207152
application number: ANDA207152
ndc (package): 72189-382-60
ndc (product): 72189-382
ndc11 (package): 72189038260
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENMedsource Pharmaceuticals12f113b3-d6b1-a7b0-e063-6294a90a999d2024-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207152
application number: ANDA207152
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENProficient Rx LPd9fa3057-c7a5-46cf-a79e-abf99a4f804d2022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207152
application number: ANDA207152

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSNe8a7c995-e473-ca87-e053-2995a90a5b802
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCDe8a7c995-e473-ca87-e053-2995a90a5b802
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSYe8a7c995-e473-ca87-e053-2995a90a5b802

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-382-607218903826060 TABLET, FILM COATED in 1 BOTTLE (72189-382-60) 2022-09-140000-00-00NoNoCurrent