Tramadol Hydrochloride and Acetaminophen

Product NDC
68788-7855
11-digit product format
687887855
Labeler code
68788
Product ID
68788-7855_1aba4d2b-98ce-454e-8828-59c3a70627d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA090485
Marketing category
ANDA
Marketing start
2021-01-29
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

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
A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENACETAMINOPHEN; TRAMADOL HYDROCHLORIDE325MG;37.5MGTABLET / ORALABRS2009-12-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090485-001AB

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 UTC2026-02A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALABRS2009-12-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALABRS2009-12-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALABRS2009-12-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALABRS2009-12-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALABRS2009-12-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALABRS2009-12-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALABRS2009-12-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALABRS2009-12-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALABRS2009-12-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALABRS2009-12-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALABRS2009-12-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALABRS2009-12-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALABRS2009-12-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALABRS2009-12-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2009-12-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2009-12-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2009-12-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2009-12-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2009-12-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2009-12-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2009-12-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2009-12-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2009-12-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2009-12-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2009-12-093f01610625f2…
2019-09-15 20:21 UTC2019-09A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2009-12-09b00525d2431f…
2019-07-19 19:46 UTC2019-07A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2009-12-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALABRS2009-12-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALABRS2009-12-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALABRS2009-12-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALABRS2009-12-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALABRS2009-12-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALABRS2009-12-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALABRS2009-12-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALABRS2009-12-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2009-12-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2009-12-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2009-12-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2009-12-09e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090485-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2009-12-09cb3db0bc1861…

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 UTC2026-02A090485-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090485-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090485-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090485-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090485-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090485-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090485-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090485-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090485-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090485-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090485-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090485-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090485-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090485-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090485-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090485-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090485-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090485-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090485-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090485-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090485-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090485-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090485-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090485-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090485-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090485-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090485-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090485-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090485-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090485-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090485-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090485-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090485-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090485-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090485-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090485-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090485-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090485-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090485-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090485-001AB1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAMADOL HYDROCHLORIDE325 mg/1
ACETAMINOPHEN37.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9N7R477WCKInternal UNII lookup
362O9ITL9DInternal 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
96094578-5348-4955-8e91-1c9163315d5aAvailable 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
68788-7855-2Tramadol Hydrochloride and Acetaminophen20 in 1 BOTTLETABLET205
68788-7855-3Tramadol Hydrochloride and Acetaminophen30 in 1 BOTTLETABLET305
68788-7855-9Tramadol Hydrochloride and Acetaminophen90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7855-2EA - Each68788-78557b7e9385-eec8-4f9b-9993-497a61a2fed712021-03-02
68788-7855-3EA - Each68788-78553b9db152-a343-4a84-8cd7-ecb703f1e4a012021-03-02
68788-7855-9EA - Each68788-78553afd6acc-308d-48b6-a9d1-a011744e8db612021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7855TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 3 package rows20240822_96094578-5348-4955-8e91-1c9163315d5a.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tramadol/APAPTRAMADOL/APAPDirect_rx4e40f55e-1d8e-ce2f-e063-6294a90a7bec2026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090485
application number: ANDA090485
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENAvPAK244f6e5d-e1b4-ba8b-ca6f-af2d8a31d5f02026-01-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090485
application number: ANDA090485
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENAmneal Pharmaceuticals of New York LLCd51600e2-2f73-483c-9b2e-f142bafff16d2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090485
application number: ANDA090485
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENPreferred Pharmaceuticals Inc.96094578-5348-4955-8e91-1c9163315d5a2025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090485
application number: ANDA090485
ndc (product): 68788-7855
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENBryant Ranch Prepackf33fcd05-2c95-48dd-884b-5ed9c25c2ccf2024-08-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090485
application number: ANDA090485
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENAsclemed USA, Inc.52693021-f60f-43bc-9b05-43db186213462022-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090485
application number: ANDA090485
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENProficient Rx LP1ad89537-3e59-438c-b646-b3c93b7908532021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090485
application number: ANDA090485

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSN96094578-5348-4955-8e91-1c9163315d5a5
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCD96094578-5348-4955-8e91-1c9163315d5a5
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSY96094578-5348-4955-8e91-1c9163315d5a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7855-26878878550220 TABLET in 1 BOTTLE (68788-7855-2) 20 tablet2021-01-290000-00-00NoNoCurrent
68788-7855-36878878550330 TABLET in 1 BOTTLE (68788-7855-3) 30 tablet2021-01-290000-00-00NoNoCurrent
68788-7855-96878878550990 TABLET in 1 BOTTLE (68788-7855-9) 90 tablet2021-01-290000-00-00NoNoCurrent