FDA.reportPublic FDA data

38779-0497-8

Product NDC
38779-0497
Requested package NDC
38779-0497-8
11-digit product format
387790497
Labeler code
38779
Product ID
38779-0497_59e648c9-9ff1-85ee-e063-6394a90aa685
Type
BULK INGREDIENT
Nonproprietary name
Phenylbutazone
Dosage form
POWDER
Marketing category
BULK INGREDIENT
Marketing start
2012-04-16
Substance
PHENYLBUTAZONE
Active strength
1 g/g
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished packagepackage38779-049738779-0497-8UNFINISHEDActive or certified unfinished drug listing2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-06-01 22:24 UTC · source 2019-05-30unfinished packagepackage38779-049738779-0497-8UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip5b2001dcd8f5…54b53d4dc9e4…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
No
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLBUTAZONE1 g/g

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
38779-0497-3GM - Gram38779-0497a7d679d6-ec47-47e2-b4f1-349997c9b13d12013-08-02
38779-0497-4GM - Gram38779-0497c9b99cf8-5412-417a-b943-c9204025b9ff12013-08-02
38779-0497-5GM - Gram38779-04974e539cfb-1ed4-436e-83b5-3f967459358b12013-08-02
38779-0497-7GM - Gram38779-0497eed9b23e-e27c-4893-9398-a752da07196e12013-08-02
38779-0497-8GM - Gram38779-04973e90ba88-3f94-495d-a5a6-0a6bc8af67cd12013-08-02
38779-0497-9GM - Gram38779-04972b7e3af0-61d8-4c99-93f0-96f3407b12b412013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PhenylbutazoneACTIVE INGREDIENTGN5P7K3T8SPHENYLBUTAZONE POWDER [MEDISCA INC.]1
PhenylbutazoneACTIVE MOIETYGN5P7K3T8SPHENYLBUTAZONE POWDER [MEDISCA INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startStatus
38779-0497-838779049708500 g in 1 JAR (38779-0497-8)500 g16-APR-12Current