FDA.reportPublic FDA data

oxycodone and acetaminophen

Product NDC
72887-683
11-digit product format
728870683
Labeler code
72887
Product ID
72887-683_4d2337f3-a324-e04a-e063-6394a90a0a35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxycodone and acetaminophen tablets
Dosage form
TABLET
Route
ORAL
Labeler
FH2 Pharma LLC
Application
ANDA040608
Marketing category
ANDA
Marketing start
2020-07-01
Substance
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Active strength
300; 10 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
oxycodone and acetaminophen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN300 mg/1
OXYCODONE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, C1ENJ2TE6C
Rxcui1014599, 1014615, 1014632, 1037259

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72887-683-03oxycodone and acetaminophen30 in 1 BOTTLE, PLASTICTABLET3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72887-683-03EA - Each72887-683fba3b068-5f94-47fb-994a-1b5df234152a12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72887-683OXYCODONE AND ACETAMINOPHEN TABLET OXYCODONE AND ACETAMINOPHEN (OXYCODONE AND ACETAMINOPHEN TABLETS) TABLET [FH2 PHARMA LLC]10Current NDC, Legacy NDC, 1 package rows20250223_88d97caf-bcf5-3cde-e053-2995a90acf4a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014599oxyCODONE HCl 10 MG / acetaminophen 300 MG Oral TabletPSN88d97caf-bcf5-3cde-e053-2995a90acf4a11
1037259oxyCODONE HCl 2.5 MG / acetaminophen 300 MG Oral TabletPSN88d97caf-bcf5-3cde-e053-2995a90acf4a11
1014615oxyCODONE HCl 5 MG / acetaminophen 300 MG Oral TabletPSN88d97caf-bcf5-3cde-e053-2995a90acf4a11
1014632oxyCODONE HCl 7.5 MG / acetaminophen 300 MG Oral TabletPSN88d97caf-bcf5-3cde-e053-2995a90acf4a11
1014599acetaminophen 300 MG / oxycodone hydrochloride 10 MG Oral TabletSCD88d97caf-bcf5-3cde-e053-2995a90acf4a11
1037259acetaminophen 300 MG / oxycodone hydrochloride 2.5 MG Oral TabletSCD88d97caf-bcf5-3cde-e053-2995a90acf4a11
1014615acetaminophen 300 MG / oxycodone hydrochloride 5 MG Oral TabletSCD88d97caf-bcf5-3cde-e053-2995a90acf4a11
1014632acetaminophen 300 MG / oxycodone hydrochloride 7.5 MG Oral TabletSCD88d97caf-bcf5-3cde-e053-2995a90acf4a11
1014615APAP 300 MG / oxycodone 5 MG Oral TabletSY88d97caf-bcf5-3cde-e053-2995a90acf4a11
1014599APAP 300 MG / oxycodone hydrochloride 10 MG Oral TabletSY88d97caf-bcf5-3cde-e053-2995a90acf4a11
1037259APAP 300 MG / Oxycodone Hydrochloride 2.5 MG Oral TabletSY88d97caf-bcf5-3cde-e053-2995a90acf4a11
1014615APAP 300 MG / Oxycodone Hydrochloride 5 MG Oral TabletSY88d97caf-bcf5-3cde-e053-2995a90acf4a11
1014632APAP 300 MG / Oxycodone Hydrochloride 7.5 MG Oral TabletSY88d97caf-bcf5-3cde-e053-2995a90acf4a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72887-683-037288706830330 TABLET in 1 BOTTLE, PLASTIC (72887-683-03) 30 tablet2020-09-250000-00-00NoNoCurrent