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

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 Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9N7R477WCK
Rxcui836395

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

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