Xipere

Product NDC
24208-040
11-digit product format
242080040
Labeler code
24208
Product ID
24208-040_40a863fe-f804-71ae-e063-6294a90af8fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
triamcinolone acetonide
Dosage form
INJECTION, SUSPENSION
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Application
NDA211950
Marketing category
NDA
Marketing start
2021-12-17
Substance
TRIAMCINOLONE ACETONIDE
Active strength
40 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Xipere
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIAMCINOLONE ACETONIDE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF446C597KA
Rxcui2585221, 2585226

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d4d7da1a-7fd4-628e-cdae-89e749b1c534Product name720260127
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
75f7e47b-8736-a182-fc44-22aca8d79689Product name220251211
62986c8d-91f1-b1ba-b5a3-8b54b75bb8c2Product name620250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
e42f429b-c4e5-0402-e1c5-730154df4060Product name420240205
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
38d4de13-64b3-4057-b91c-4b5126962341Product name120220516
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
089e0644-1ea8-8654-4113-39f960dd57d5Product name320210115
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
5331c9c8-f64b-11e6-ccf1-071c477fcb0bProduct name720190612
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
9f64e0dc-109c-9660-8e0e-91ec987b3817Product name620171204
dfa879a3-32de-49f0-a7ba-9b9c3e13002fProduct name120171204
8de20f81-8411-4cf1-a8b2-03404ee56d01Product name320171109
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
a5f1a68c-0352-4f34-46a3-9b4eed239ed8Product name220160819
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
355b2224-0895-7135-83f5-d099a6a82a0aProduct name120140508
55be6b50-8cc0-f0f1-74a1-3416a91193aaProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cfProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
89b93c13-4be8-69f3-b33b-63e64feffb9bProduct name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24208-040-01Xipere1 in 1 CARTONINJECTION, SUSPENSION17
24208-040-01Xipere1 in 1 TRAYINJECTION, SUSPENSION17
24208-040-02Xipere0.9 mL in 1 VIALINJECTION, SUSPENSION0.97
24208-040-40Xipere1 in 1 CARTONINJECTION, SUSPENSION17
24208-040-40Xipere1 in 1 TRAYINJECTION, SUSPENSION17
24208-040-41Xipere0.9 mL in 1 VIALINJECTION, SUSPENSION0.97

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-040-40ML - Milliliter24208-040da6c08ed-251c-4030-bfaf-2d7e536d5c9812023-01-09
24208-040-41ML - Milliliter24208-040676b47a3-48f2-4885-932c-12f0b33f42bd12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-040XIPERE (TRIAMCINOLONE ACETONIDE) INJECTION, SUSPENSION [BAUSCH & LOMB INCORPORATED]5Current NDC, Legacy NDC, 6 package rows20230202_ea6ad429-967f-4f75-a33d-e06f849bee80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2585221triamcinolone acetonide 40 MG in 0.9 ML InjectionPSNea6ad429-967f-4f75-a33d-e06f849bee807
2585226XIPERE 40 MG in 0.9 ML InjectionPSNea6ad429-967f-4f75-a33d-e06f849bee807
25852260.9 ML triamcinolone acetonide 40 MG/ML Injection [Xipere]SBDea6ad429-967f-4f75-a33d-e06f849bee807
25852210.9 ML triamcinolone acetonide 40 MG/ML InjectionSCDea6ad429-967f-4f75-a33d-e06f849bee807
25852260.9 ML Xipere 40 MG/ML InjectionSYea6ad429-967f-4f75-a33d-e06f849bee807
2585221triamcinolone acetonide 40 MG per 0.9 ML InjectionSYea6ad429-967f-4f75-a33d-e06f849bee807
2585226Xipere 40 MG per 0.9 ML InjectionSYea6ad429-967f-4f75-a33d-e06f849bee807

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24208-040-01242080040011 TRAY in 1 CARTON (24208-040-01) / 1 VIAL in 1 TRAY / .9 mL in 1 VIAL (24208-040-02) 1 tray2021-12-170000-00-00YesNoCurrent
24208-040-02242080040020.9 mL in 1 VIAL0.9 mlHistorical
24208-040-40242080040401 TRAY in 1 CARTON (24208-040-40) / 1 VIAL in 1 TRAY / .9 mL in 1 VIAL (24208-040-41) 1 tray2021-12-170000-00-00NoNoCurrent
24208-040-41242080040410.9 mL in 1 VIAL0.9 mlHistorical