FDA.reportPublic FDA data

OLPRUVA

Product NDC
72542-500
11-digit product format
725420500
Labeler code
72542
Product ID
72542-500_7720f74d-f161-4aaa-a421-7bf48e6c962c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium phenylbutyrate
Dosage form
KIT
Route
ORAL
Labeler
Acer Therapeutics Inc.
Application
NDA214860
Marketing category
NDA
Marketing start
2022-12-22
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OLPRUVA
Listing expiration
2027-12-31

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0cc537b1-c2e1-c627-bac5-cebf6929cf73Product name320240109
5b2d409d-7740-4999-9561-96950a3ff604Product name120230919
33ad3946-5a41-4c5a-ac56-c03c9275532fProduct name120230313
80e18c01-dd53-4091-b66d-ad9549805dabProduct name120221116

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72542-002-01OLPRUVA1 in 1 PACKETFOR SUSPENSION12 g4
72542-003-01OLPRUVA1 in 1 PACKETFOR SUSPENSION13 g4
72542-500-02OLPRUVA1 in 1 BOXKIT14
72542-500-18OLPRUVA90 in 1 CARTONKIT904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72542-500-02EA - Each72542-5001dfc453d-049c-44f0-ad48-fa3a2e30502112023-07-06
72542-500-18EA - Each72542-5001303d4bc-27d7-408f-a054-777088aa61e312023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72542-500OLPRUVA (SODIUM PHENYLBUTYRATE) KIT [ACER THERAPEUTICS INC.]4Current NDC, Legacy NDC, 4 package rows20241220_89abc31c-43e8-4809-9eb7-172cb31a86f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2626387{1 (sodium phenylbutyrate 2000 MG Granules for Oral Suspension [Olpruva]) } Pack [Olpruva 2 GM Pack]BPCK89abc31c-43e8-4809-9eb7-172cb31a86f14
2626393{1 (sodium phenylbutyrate 2000 MG Granules for Oral Suspension [Olpruva]) / 1 (sodium phenylbutyrate 3000 MG Granules for Oral Suspension [Olpruva]) } Pack [Olpruva 5 GM Pack]BPCK89abc31c-43e8-4809-9eb7-172cb31a86f14
2626389{1 (sodium phenylbutyrate 3000 MG Granules for Oral Suspension [Olpruva]) } Pack [Olpruva 3 GM Pack]BPCK89abc31c-43e8-4809-9eb7-172cb31a86f14
2626401{1 (sodium phenylbutyrate 3000 MG Granules for Oral Suspension [Olpruva]) / 1 (sodium phenylbutyrate 3670 MG Granules for Oral Suspension [Olpruva]) } Pack [Olpruva 6.67 GM Pack]BPCK89abc31c-43e8-4809-9eb7-172cb31a86f14
2626391{2 (sodium phenylbutyrate 2000 MG Granules for Oral Suspension [Olpruva]) } Pack [Olpruva 4 GM Pack]BPCK89abc31c-43e8-4809-9eb7-172cb31a86f14
2626395{2 (sodium phenylbutyrate 3000 MG Granules for Oral Suspension [Olpruva]) } Pack [Olpruva 6 GM Pack]BPCK89abc31c-43e8-4809-9eb7-172cb31a86f14
2626386{1 (sodium phenylbutyrate 2000 MG Granules for Oral Suspension) } PackGPCK89abc31c-43e8-4809-9eb7-172cb31a86f14
2626392{1 (sodium phenylbutyrate 2000 MG Granules for Oral Suspension) / 1 (sodium phenylbutyrate 3000 MG Granules for Oral Suspension) } PackGPCK89abc31c-43e8-4809-9eb7-172cb31a86f14
2626388{1 (sodium phenylbutyrate 3000 MG Granules for Oral Suspension) } PackGPCK89abc31c-43e8-4809-9eb7-172cb31a86f14
2626400{1 (sodium phenylbutyrate 3000 MG Granules for Oral Suspension) / 1 (sodium phenylbutyrate 3670 MG Granules for Oral Suspension) } PackGPCK89abc31c-43e8-4809-9eb7-172cb31a86f14
2626390{2 (sodium phenylbutyrate 2000 MG Granules for Oral Suspension) } PackGPCK89abc31c-43e8-4809-9eb7-172cb31a86f14
2626394{2 (sodium phenylbutyrate 3000 MG Granules for Oral Suspension) } PackGPCK89abc31c-43e8-4809-9eb7-172cb31a86f14
2626375OLPRUVA 2 GM Granules for Oral SuspensionPSN89abc31c-43e8-4809-9eb7-172cb31a86f14
2626387OLPRUVA 2 GM PackPSN89abc31c-43e8-4809-9eb7-172cb31a86f14
2626378OLPRUVA 3 GM Granules for Oral SuspensionPSN89abc31c-43e8-4809-9eb7-172cb31a86f14
2626389OLPRUVA 3 GM PackPSN89abc31c-43e8-4809-9eb7-172cb31a86f14
2626382OLPRUVA 3.67 GM Granules for Oral SuspensionPSN89abc31c-43e8-4809-9eb7-172cb31a86f14
2626391OLPRUVA 4 GM PackPSN89abc31c-43e8-4809-9eb7-172cb31a86f14
2626393OLPRUVA 5 GM PackPSN89abc31c-43e8-4809-9eb7-172cb31a86f14
2626395OLPRUVA 6 GM PackPSN89abc31c-43e8-4809-9eb7-172cb31a86f14
2626401OLPRUVA 6.67 GM PackPSN89abc31c-43e8-4809-9eb7-172cb31a86f14
2626369sodium phenylbutyrate 2 GM Granules for Oral SuspensionPSN89abc31c-43e8-4809-9eb7-172cb31a86f14
2626386sodium phenylbutyrate 2 GM PackPSN89abc31c-43e8-4809-9eb7-172cb31a86f14
2626376sodium phenylbutyrate 3 GM Granules for Oral SuspensionPSN89abc31c-43e8-4809-9eb7-172cb31a86f14
2626388sodium phenylbutyrate 3 GM PackPSN89abc31c-43e8-4809-9eb7-172cb31a86f14
2626380sodium phenylbutyrate 3.67 GM Granules for Oral SuspensionPSN89abc31c-43e8-4809-9eb7-172cb31a86f14
2626390sodium phenylbutyrate 4 GM PackPSN89abc31c-43e8-4809-9eb7-172cb31a86f14
2626392sodium phenylbutyrate 5 GM PackPSN89abc31c-43e8-4809-9eb7-172cb31a86f14
2626394sodium phenylbutyrate 6 GM PackPSN89abc31c-43e8-4809-9eb7-172cb31a86f14
2626400sodium phenylbutyrate 6.67 GM PackPSN89abc31c-43e8-4809-9eb7-172cb31a86f14
2626375sodium phenylbutyrate 2000 MG Granules for Oral Suspension [Olpruva]SBD89abc31c-43e8-4809-9eb7-172cb31a86f14
2626378sodium phenylbutyrate 3000 MG Granules for Oral Suspension [Olpruva]SBD89abc31c-43e8-4809-9eb7-172cb31a86f14
2626382sodium phenylbutyrate 3670 MG Granules for Oral Suspension [Olpruva]SBD89abc31c-43e8-4809-9eb7-172cb31a86f14
2626369sodium phenylbutyrate 2000 MG Granules for Oral SuspensionSCD89abc31c-43e8-4809-9eb7-172cb31a86f14
2626376sodium phenylbutyrate 3000 MG Granules for Oral SuspensionSCD89abc31c-43e8-4809-9eb7-172cb31a86f14
2626380sodium phenylbutyrate 3670 MG Granules for Oral SuspensionSCD89abc31c-43e8-4809-9eb7-172cb31a86f14
2626375Olpruva 2 GM Granules for Oral SuspensionSY89abc31c-43e8-4809-9eb7-172cb31a86f14
2626387Olpruva 2 GM PackSY89abc31c-43e8-4809-9eb7-172cb31a86f14
2626378Olpruva 3 GM Granules for Oral SuspensionSY89abc31c-43e8-4809-9eb7-172cb31a86f14
2626389Olpruva 3 GM PackSY89abc31c-43e8-4809-9eb7-172cb31a86f14
2626382Olpruva 3.67 GM Granules for Oral SuspensionSY89abc31c-43e8-4809-9eb7-172cb31a86f14
2626391Olpruva 4 GM PackSY89abc31c-43e8-4809-9eb7-172cb31a86f14
2626393Olpruva 5 GM PackSY89abc31c-43e8-4809-9eb7-172cb31a86f14
2626395Olpruva 6 GM PackSY89abc31c-43e8-4809-9eb7-172cb31a86f14
2626401Olpruva 6.67 GM PackSY89abc31c-43e8-4809-9eb7-172cb31a86f14
2626369sodium phenylbutyrate 2 GM Granules for Oral SuspensionSY89abc31c-43e8-4809-9eb7-172cb31a86f14
2626386sodium phenylbutyrate 2 GM PackSY89abc31c-43e8-4809-9eb7-172cb31a86f14
2626376sodium phenylbutyrate 3 GM Granules for Oral SuspensionSY89abc31c-43e8-4809-9eb7-172cb31a86f14
2626388sodium phenylbutyrate 3 GM PackSY89abc31c-43e8-4809-9eb7-172cb31a86f14
2626380sodium phenylbutyrate 3.67 GM Granules for Oral SuspensionSY89abc31c-43e8-4809-9eb7-172cb31a86f14
2626390sodium phenylbutyrate 4 GM PackSY89abc31c-43e8-4809-9eb7-172cb31a86f14
2626392sodium phenylbutyrate 5 GM PackSY89abc31c-43e8-4809-9eb7-172cb31a86f14
2626394sodium phenylbutyrate 6 GM PackSY89abc31c-43e8-4809-9eb7-172cb31a86f14
2626400sodium phenylbutyrate 6.67 GM PackSY89abc31c-43e8-4809-9eb7-172cb31a86f14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72542-002-01725420002011 in 1 PACKETHistorical
72542-003-01725420003011 in 1 PACKETHistorical
72542-500-02725420500021 in 1 BOXHistorical
72542-500-187254205001890 BOX in 1 CARTON (72542-500-18) / 1 KIT in 1 BOX (72542-500-02) * 1 FOR SUSPENSION in 1 PACKET (72542-003-01) * 1 FOR SUSPENSION in 1 PACKET (72542-000-01) * 1 FOR SUSPENSION in 1 PACKET (72542-002-01) 90 box2022-12-220000-00-00NoNoCurrent