FDA.reportPublic FDA data

Oxycodone and Acetaminophen

Product NDC
50436-3913
11-digit product format
504363913
Labeler code
50436
Product ID
50436-3913_0d06ed8f-ecbd-4ac9-835b-b35cf31a10fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA201447
Marketing category
ANDA
Marketing start
2013-12-10
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength
5 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
b8cd3792-f010-440e-ac63-7713119fde04Product name920220110
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
ac683e31-73f8-f1cd-ff51-87d7b0d20ab3Product name920190611
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
b7a189a6-82e9-f884-a16b-8cdc7e7d1556Product name620170913
5da64f4c-1e90-423d-af7a-5a52bb3e823eProduct name420170726
334cd9e0-ccc1-4fe7-b3a9-7d5942867ee6Product name120170628
8e48b6b8-3a2f-4e0d-b7c9-38d70393b778Product name120161103
68d3ff71-7803-4cf4-ba84-71ce4712df22Product name120160620
07e5b999-fda7-79c9-8f77-8380537ade79Product name420160517
8a245632-e24f-4ccc-b671-995d89c96ebcProduct name120141203
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
7fa873c5-fb27-7119-0a05-634ad477dea7Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
f46484d2-0de6-24f4-bf73-a8f2af6723efProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-3913-12021-01-29C16284748780-1ba0f9c33-3621-a910-e053-dadaa90a0b85Oxycodone and Acetaminophen Tablets, USP
50436-3913-22021-01-29C16284748780-1ba0f9c33-3621-a910-e053-dadaa90a0b85Oxycodone and Acetaminophen Tablets, USP
50436-3913-32021-01-29C16284748780-1ba0f9c33-3621-a910-e053-dadaa90a0b85Oxycodone and Acetaminophen Tablets, USP
50436-3913-52021-01-29C16284748780-1ba0f9c33-3621-a910-e053-dadaa90a0b85Oxycodone and Acetaminophen Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-3913-1Oxycodone and Acetaminophen30 in 1 BOTTLETABLET3017
50436-3913-2Oxycodone and Acetaminophen60 in 1 BOTTLETABLET6017
50436-3913-3Oxycodone and Acetaminophen90 in 1 BOTTLETABLET9017
50436-3913-5Oxycodone and Acetaminophen24 in 1 BOTTLETABLET2417

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-3913-1EA - Each50436-39130547d0fc-1b24-40a3-9d6a-3d45e84be3f412015-10-02
50436-3913-2EA - Each50436-39131baff640-5ec3-438d-9ae6-b874dca3474612015-10-02
50436-3913-5EA - Each50436-3913eb24ead0-169f-4b25-9257-69804791a03212018-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DOXYCODONE AND ACETAMINOPHEN TABLET [UNIT DOSE SERVICES]2
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE AND ACETAMINOPHEN TABLET [UNIT DOSE SERVICES]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DOXYCODONE AND ACETAMINOPHEN TABLET [UNIT DOSE SERVICES]2
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE AND ACETAMINOPHEN TABLET [UNIT DOSE SERVICES]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE AND ACETAMINOPHEN TABLET [UNIT DOSE SERVICES]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48OXYCODONE AND ACETAMINOPHEN TABLET [UNIT DOSE SERVICES]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EOXYCODONE AND ACETAMINOPHEN TABLET [UNIT DOSE SERVICES]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYCODONE AND ACETAMINOPHEN TABLET [UNIT DOSE SERVICES]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE AND ACETAMINOPHEN TABLET [UNIT DOSE SERVICES]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE AND ACETAMINOPHEN TABLET [UNIT DOSE SERVICES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-3913OXYCODONE AND ACETAMINOPHEN TABLET [UNIT DOSE SERVICES]17Legacy NDC, 4 package rows20190509_8f84a572-a5a9-4c7b-adc5-ad209393befa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049214oxyCODONE 10 MG / acetaminophen 325 MG Oral TabletPSN8f84a572-a5a9-4c7b-adc5-ad209393befa17
1049221oxyCODONE 5 MG / acetaminophen 325 MG Oral TabletPSN8f84a572-a5a9-4c7b-adc5-ad209393befa17
1049225oxyCODONE 7.5 MG / acetaminophen 325 MG Oral TabletPSN8f84a572-a5a9-4c7b-adc5-ad209393befa17
1049214acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral TabletSCD8f84a572-a5a9-4c7b-adc5-ad209393befa17
1049221acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral TabletSCD8f84a572-a5a9-4c7b-adc5-ad209393befa17
1049225acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSCD8f84a572-a5a9-4c7b-adc5-ad209393befa17
1049214APAP 325 MG / oxycodone hydrochloride 10 MG Oral TabletSY8f84a572-a5a9-4c7b-adc5-ad209393befa17
1049221APAP 325 MG / oxycodone hydrochloride 5 MG Oral TabletSY8f84a572-a5a9-4c7b-adc5-ad209393befa17
1049225APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSY8f84a572-a5a9-4c7b-adc5-ad209393befa17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-3913-15043639130130 in 1 BOTTLEHistorical
50436-3913-25043639130260 in 1 BOTTLEHistorical
50436-3913-35043639130390 in 1 BOTTLEHistorical
50436-3913-55043639130524 in 1 BOTTLEHistorical