FDA.reportPublic FDA data

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

Product NDC
52959-814
11-digit product format
529590814
Labeler code
52959
Product ID
52959-814_37302f24-ba1e-4146-b42c-549a8dd0e9e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA077184
Marketing category
ANDA
Marketing start
2005-12-16
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN
Active strength
38 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-814-122019-11-13C16284748780-197449f38-d2dd-f6ea-e053-dbdaa90aa703Rx only
52959-814-202019-11-13C16284748780-197449f38-d2dd-f6ea-e053-dbdaa90aa703Rx only
52959-814-302019-11-13C16284748780-197449f38-d2dd-f6ea-e053-dbdaa90aa703Rx only
52959-814-402019-11-13C16284748780-197449f38-d2dd-f6ea-e053-dbdaa90aa703Rx only
52959-814-602019-11-13C16284748780-197449f38-d2dd-f6ea-e053-dbdaa90aa703Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-814-12TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN12 in 1 VIALTABLET, FILM COATED122
52959-814-20TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN20 in 1 VIALTABLET, FILM COATED202
52959-814-30TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN30 in 1 VIALTABLET, FILM COATED302
52959-814-40TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN40 in 1 VIALTABLET, FILM COATED402
52959-814-60TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN60 in 1 VIALTABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-814-12EA - Each52959-8142980f570-ecd2-4f71-a789-b78ec8c2668c12012-07-24
52959-814-20EA - Each52959-814dd6a306f-73f7-4c49-85be-4ca2b20f428312012-07-24
52959-814-30EA - Each52959-814efb80c96-3628-44f0-9a8b-5bd8b58063d812012-07-24
52959-814-40EA - Each52959-8143bf95a27-9b1a-4bce-95bf-88e28473adbe12012-07-24
52959-814-60EA - Each52959-814cc45b3a4-ac7c-4e46-941d-71982d8e054a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ETRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-814TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 5 package rows20120425_45190f26-d4cc-4cac-86b4-f79ea3b88fa2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSN45190f26-d4cc-4cac-86b4-f79ea3b88fa22
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCD45190f26-d4cc-4cac-86b4-f79ea3b88fa22
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSY45190f26-d4cc-4cac-86b4-f79ea3b88fa22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-814-125295908141212 in 1 VIALHistorical
52959-814-205295908142020 in 1 VIALHistorical
52959-814-305295908143030 in 1 VIALHistorical
52959-814-405295908144040 in 1 VIALHistorical
52959-814-605295908146060 in 1 VIALHistorical