FDA.reportPublic FDA data

Prolate

Product NDC
72245-648
11-digit product format
722450648
Labeler code
72245
Product ID
72245-648_4bbacb0d-57c5-93e7-e063-6394a90a050b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxycodone hydrochloride and acetaminophen
Dosage form
SOLUTION
Route
ORAL
Labeler
Forte Bio-Pharma LLC
Application
ANDA202142
Marketing category
ANDA
Marketing start
2020-03-01
Substance
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Active strength
300; 10 mg/5mL; mg/5mL
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/5mL
OXYCODONE HYDROCHLORIDE10 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, C1ENJ2TE6C
Rxcui2105822, 2281851

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
72245-648-12Prolate120 mL in 1 BOTTLE, PLASTICSOLUTION1207
72245-648-50Prolate500 mL in 1 BOTTLE, PLASTICSOLUTION5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72245-648-12ML - Milliliter72245-648945284ea-dff0-4169-979d-ee908805e04312021-04-08
72245-648-50ML - Milliliter72245-6483d5e0c17-3eb9-41d6-a3a1-0c7f653369c012021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72245-648PROLATE (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) SOLUTION [FORTE BIO-PHARMA LLC]5Current NDC, Legacy NDC, 2 package rows20240110_9d75ad3b-bc9b-0c22-e053-2a95a90ac71e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2105822oxyCODONE HCl 10 MG / acetaminophen 300 MG in 5 mL Oral SolutionPSN9d75ad3b-bc9b-0c22-e053-2a95a90ac71e7
2281851Prolate 10 MG / 300 MG in 5 mL Oral SolutionPSN9d75ad3b-bc9b-0c22-e053-2a95a90ac71e7
2281851acetaminophen 60 MG/ML / oxycodone hydrochloride 2 MG/ML Oral Solution [Prolate]SBD9d75ad3b-bc9b-0c22-e053-2a95a90ac71e7
2105822acetaminophen 60 MG/ML / oxycodone hydrochloride 2 MG/ML Oral SolutionSCD9d75ad3b-bc9b-0c22-e053-2a95a90ac71e7
2105822APAP 60 MG/ML / Oxycodone Hydrochloride 2 MG/ML Oral SolutionSY9d75ad3b-bc9b-0c22-e053-2a95a90ac71e7
2281851APAP 60 MG/ML / Oxycodone Hydrochloride 2 MG/ML Oral Solution [Prolate]SY9d75ad3b-bc9b-0c22-e053-2a95a90ac71e7
2105822oxycodone HCl 10 MG / acetaminophen 300 MG per 5 ML Oral SolutionSY9d75ad3b-bc9b-0c22-e053-2a95a90ac71e7
2105822oxycodone HCl 2 MG/ML / acetaminophen 60 MG/ML Oral SolutionSY9d75ad3b-bc9b-0c22-e053-2a95a90ac71e7
2281851Prolate (oxycodone HCl 10 MG / acetaminophen 300 MG per 5 ML) Oral SolutionSY9d75ad3b-bc9b-0c22-e053-2a95a90ac71e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72245-648-1272245064812120 mL in 1 BOTTLE, PLASTIC (72245-648-12) 120 ml2020-03-010000-00-00NoNoCurrent
72245-648-5072245064850500 mL in 1 BOTTLE, PLASTIC (72245-648-50) 500 ml2020-03-010000-00-00NoNoCurrent