Tramadol Hydrochloride and Acetaminophen

Product NDC
71335-1742
11-digit product format
713351742
Labeler code
71335
Product ID
71335-1742_c3c5af52-f6d0-43f9-8adf-c046a433c4db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride and Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207152
Marketing category
ANDA
Marketing start
2017-03-22
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
2027-12-31
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
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
2027-12-31

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
ccf465b5-8ef8-4445-a0d4-23b5cf13188cAvailable 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
71335-1742-1Tramadol Hydrochloride and Acetaminophen30 in 1 BOTTLETABLET, FILM COATED30105
71335-1742-2Tramadol Hydrochloride and Acetaminophen60 in 1 BOTTLETABLET, FILM COATED60105
71335-1742-3Tramadol Hydrochloride and Acetaminophen90 in 1 BOTTLETABLET, FILM COATED90105
71335-1742-4Tramadol Hydrochloride and Acetaminophen120 in 1 BOTTLETABLET, FILM COATED120105
71335-1742-5Tramadol Hydrochloride and Acetaminophen20 in 1 BOTTLETABLET, FILM COATED20105
71335-1742-6Tramadol Hydrochloride and Acetaminophen40 in 1 BOTTLETABLET, FILM COATED40105
71335-1742-7Tramadol Hydrochloride and Acetaminophen100 in 1 BOTTLETABLET, FILM COATED100105
71335-1742-8Tramadol Hydrochloride and Acetaminophen15 in 1 BOTTLETABLET, FILM COATED15105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1742-2EA - Each71335-1742d80603e8-da30-467a-be84-ad50436cca9012022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1742TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 8 package rows20250125_ccf465b5-8ef8-4445-a0d4-23b5cf13188c.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
ndc (product): 71335-1742
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
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 TabletPSNccf465b5-8ef8-4445-a0d4-23b5cf13188c105
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCDccf465b5-8ef8-4445-a0d4-23b5cf13188c105
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSYccf465b5-8ef8-4445-a0d4-23b5cf13188c105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1742-17133517420130 TABLET, FILM COATED in 1 BOTTLE (71335-1742-1) 2020-12-280000-00-00NoNoCurrent
71335-1742-27133517420260 TABLET, FILM COATED in 1 BOTTLE (71335-1742-2) 2021-01-260000-00-00NoNoCurrent
71335-1742-37133517420390 TABLET, FILM COATED in 1 BOTTLE (71335-1742-3) 2021-03-050000-00-00NoNoCurrent
71335-1742-471335174204120 TABLET, FILM COATED in 1 BOTTLE (71335-1742-4) 2023-03-080000-00-00NoNoCurrent
71335-1742-57133517420520 TABLET, FILM COATED in 1 BOTTLE (71335-1742-5) 2023-05-030000-00-00NoNoCurrent
71335-1742-67133517420640 TABLET, FILM COATED in 1 BOTTLE (71335-1742-6) 2024-04-050000-00-00NoNoCurrent
71335-1742-771335174207100 TABLET, FILM COATED in 1 BOTTLE (71335-1742-7) 2024-04-050000-00-00NoNoCurrent
71335-1742-87133517420815 TABLET, FILM COATED in 1 BOTTLE (71335-1742-8) 2024-04-050000-00-00NoNoCurrent