FDA.reportPublic FDA data

Tramadol Hydrochloride and Acetaminophen

Product NDC
65862-922
11-digit product format
658620922
Labeler code
65862
Product ID
65862-922_e0a5c380-895e-4f05-9eaf-b27b17ad41e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride and Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
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
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
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
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
6c2894df-eeeb-4b22-ab32-8ce1601bfdfaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
43d017e1-6ae6-7555-71d1-c249236d6f26Product name420251117
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
bff1fbab-f4cc-4993-b7de-2b555ee5eb73Product name120220509
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
c563c906-2606-457c-bb1b-5a623daed55bProduct name120210511
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
43a9f8f9-34aa-8ae8-719e-5489454f7720Product name520200123
abd2f6f2-3fa7-4571-af8a-d67f89bdcb75Product name120190927
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
377068df-225f-7318-a910-a1987cdfa361Product name320170608
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
9457302e-0ca3-d9ff-0863-1b24b6107218Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d5c49867-1fe9-7a44-3319-814417011d51Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-922-01Tramadol Hydrochloride and Acetaminophen100 in 1 BOTTLETABLET, FILM COATED10015
65862-922-05Tramadol Hydrochloride and Acetaminophen500 in 1 BOTTLETABLET, FILM COATED50015
65862-922-10Tramadol Hydrochloride and Acetaminophen10 in 1 BLISTER PACKTABLET, FILM COATED1015
65862-922-30Tramadol Hydrochloride and Acetaminophen30 in 1 BOTTLETABLET, FILM COATED3015
65862-922-78Tramadol Hydrochloride and Acetaminophen10 in 1 CARTONTABLET, FILM COATED1015
65862-922-99Tramadol Hydrochloride and Acetaminophen1000 in 1 BOTTLETABLET, FILM COATED100015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-922-01EA - Each65862-922187e057e-9e3b-4c50-b719-2cf92223efb812017-07-07
65862-922-05EA - Each65862-922f68335de-1d02-4237-87a5-9f0a56f3684a12017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-922TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12Current NDC, Legacy NDC, 6 package rows20240112_6c2894df-eeeb-4b22-ab32-8ce1601bfdfa.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
ndc (product): 65862-922
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
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSNc83366d9-db60-45eb-9c2b-a2c58d45c82c101
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCDc83366d9-db60-45eb-9c2b-a2c58d45c82c101
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSYc83366d9-db60-45eb-9c2b-a2c58d45c82c101
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSN6c2894df-eeeb-4b22-ab32-8ce1601bfdfa15
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCD6c2894df-eeeb-4b22-ab32-8ce1601bfdfa15
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSY6c2894df-eeeb-4b22-ab32-8ce1601bfdfa15
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSNe8a7c995-e473-ca87-e053-2995a90a5b802
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSNd9fa3057-c7a5-46cf-a79e-abf99a4f804d2
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSNbb9e87d4-3598-8caa-e053-2a95a90ac6d02
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSNcb05d615-918d-8104-e053-2995a90aa96b2
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCDe8a7c995-e473-ca87-e053-2995a90a5b802
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCDd9fa3057-c7a5-46cf-a79e-abf99a4f804d2
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCDcb05d615-918d-8104-e053-2995a90aa96b2
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCDbb9e87d4-3598-8caa-e053-2a95a90ac6d02
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSYcb05d615-918d-8104-e053-2995a90aa96b2
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSYbb9e87d4-3598-8caa-e053-2a95a90ac6d02
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSYd9fa3057-c7a5-46cf-a79e-abf99a4f804d2
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSYe8a7c995-e473-ca87-e053-2995a90a5b802
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSN5058c2b0-5c66-4cd2-80a6-7a4678c1fd511
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSN12f113b3-d6b1-a7b0-e063-6294a90a999d1
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCD5058c2b0-5c66-4cd2-80a6-7a4678c1fd511
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCD12f113b3-d6b1-a7b0-e063-6294a90a999d1
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSY5058c2b0-5c66-4cd2-80a6-7a4678c1fd511
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSY12f113b3-d6b1-a7b0-e063-6294a90a999d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-922-0165862092201100 TABLET, FILM COATED in 1 BOTTLE (65862-922-01) 2017-03-220000-00-00NoNoCurrent
65862-922-0565862092205500 TABLET, FILM COATED in 1 BOTTLE (65862-922-05) 2017-03-220000-00-00NoNoCurrent
65862-922-106586209221010 in 1 BLISTER PACKHistorical
65862-922-306586209223030 TABLET, FILM COATED in 1 BOTTLE (65862-922-30) 2017-03-220000-00-00NoNoCurrent
65862-922-786586209227810 BLISTER PACK in 1 CARTON (65862-922-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-922-10) 10 blister pack2017-03-220000-00-00NoNoCurrent
65862-922-99658620922991000 TABLET, FILM COATED in 1 BOTTLE (65862-922-99) 2017-03-220000-00-00NoNoCurrent