FDA.reportPublic FDA data

Prolate

Product NDC
72245-683
11-digit product format
722450683
Labeler code
72245
Product ID
72245-683_4c0a051e-78a7-de5f-e063-6294a90a90c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxycodone and acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Forte Bio-Pharma LLC
Application
ANDA040608
Marketing category
ANDA
Marketing start
2020-02-17
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
Prolate
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC1ENJ2TE6C, 362O9ITL9D
Rxcui1014599, 1014615, 1014632, 2279510, 2279512, 2279514

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
72245-683-03Prolate30 in 1 BOTTLE, PLASTICTABLET308
72245-683-10Prolate100 in 1 BOTTLE, PLASTICTABLET1008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72245-683PROLATE (OXYCODONE AND ACETAMINOPHEN) TABLET [FORTE BIO-PHARMA LLC]7Current NDC, Legacy NDC, 2 package rows20241109_9cbbfa94-37b9-9652-e053-2995a90a736b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014599oxyCODONE HCl 10 MG / acetaminophen 300 MG Oral TabletPSN9cbbfa94-37b9-9652-e053-2995a90a736b8
1014615oxyCODONE HCl 5 MG / acetaminophen 300 MG Oral TabletPSN9cbbfa94-37b9-9652-e053-2995a90a736b8
1014632oxyCODONE HCl 7.5 MG / acetaminophen 300 MG Oral TabletPSN9cbbfa94-37b9-9652-e053-2995a90a736b8
2279510Prolate 10 / 300 Oral TabletPSN9cbbfa94-37b9-9652-e053-2995a90a736b8
2279512Prolate 5 / 300 Oral TabletPSN9cbbfa94-37b9-9652-e053-2995a90a736b8
2279514Prolate 7.5 / 300 Oral TabletPSN9cbbfa94-37b9-9652-e053-2995a90a736b8
2279510acetaminophen 300 MG / oxycodone hydrochloride 10 MG Oral Tablet [Prolate]SBD9cbbfa94-37b9-9652-e053-2995a90a736b8
2279512acetaminophen 300 MG / oxycodone hydrochloride 5 MG Oral Tablet [Prolate]SBD9cbbfa94-37b9-9652-e053-2995a90a736b8
2279514acetaminophen 300 MG / oxycodone hydrochloride 7.5 MG Oral Tablet [Prolate]SBD9cbbfa94-37b9-9652-e053-2995a90a736b8
1014599acetaminophen 300 MG / oxycodone hydrochloride 10 MG Oral TabletSCD9cbbfa94-37b9-9652-e053-2995a90a736b8
1014615acetaminophen 300 MG / oxycodone hydrochloride 5 MG Oral TabletSCD9cbbfa94-37b9-9652-e053-2995a90a736b8
1014632acetaminophen 300 MG / oxycodone hydrochloride 7.5 MG Oral TabletSCD9cbbfa94-37b9-9652-e053-2995a90a736b8
1014615APAP 300 MG / oxycodone 5 MG Oral TabletSY9cbbfa94-37b9-9652-e053-2995a90a736b8
1014599APAP 300 MG / oxycodone hydrochloride 10 MG Oral TabletSY9cbbfa94-37b9-9652-e053-2995a90a736b8
2279510APAP 300 MG / Oxycodone Hydrochloride 10 MG Oral Tablet [Prolate]SY9cbbfa94-37b9-9652-e053-2995a90a736b8
1014615APAP 300 MG / Oxycodone Hydrochloride 5 MG Oral TabletSY9cbbfa94-37b9-9652-e053-2995a90a736b8
2279512APAP 300 MG / Oxycodone Hydrochloride 5 MG Oral Tablet [Prolate]SY9cbbfa94-37b9-9652-e053-2995a90a736b8
1014632APAP 300 MG / Oxycodone Hydrochloride 7.5 MG Oral TabletSY9cbbfa94-37b9-9652-e053-2995a90a736b8
2279514APAP 300 MG / Oxycodone Hydrochloride 7.5 MG Oral Tablet [Prolate]SY9cbbfa94-37b9-9652-e053-2995a90a736b8
2279510Prolate (acetaminophen 300 MG / oxycodone HCl 10 MG) Oral TabletSY9cbbfa94-37b9-9652-e053-2995a90a736b8
2279512Prolate (acetaminophen 300 MG / oxycodone HCl 5 MG) Oral TabletSY9cbbfa94-37b9-9652-e053-2995a90a736b8
2279514Prolate (acetaminophen 300 MG / oxycodone HCl 7.5 MG) Oral TabletSY9cbbfa94-37b9-9652-e053-2995a90a736b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72245-683-037224506830330 TABLET in 1 BOTTLE, PLASTIC (72245-683-03) 30 tablet2020-02-170000-00-00NoNoCurrent
72245-683-1072245068310100 TABLET in 1 BOTTLE, PLASTIC (72245-683-10) 100 tablet2020-02-170000-00-00NoNoCurrent