FDA.reportPublic FDA data

Sodium phenylbutyrate

Product NDC
68475-011
Requested package NDC
68475-011-01
11-digit product format
684750011
Labeler code
68475
Product ID
68475-011_5da41af8-4b7d-4703-9e7e-8b4d7ffed8b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium phenylbutyrate
Dosage form
TABLET
Route
ORAL
Labeler
Navinta LLC
Application
ANDA220418
Marketing category
ANDA
Marketing start
2026-07-10
Substance
SODIUM PHENYLBUTYRATE
Active strength
500 mg/1
Pharmacologic classes
Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A220418-001SODIUM PHENYLBUTYRATESODIUM PHENYLBUTYRATE500MGTABLET / ORALAB2026-02-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A220418-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A220418-001SODIUM PHENYLBUTYRATE500MGTABLET / ORALAB2026-02-1784e616aacf4f…
2026-08-18 06:07:402026-07A220418-001SODIUM PHENYLBUTYRATE500MGTABLET / ORALAB2026-02-17caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220418-001SODIUM PHENYLBUTYRATE500MGTABLET / ORALAB2026-02-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A220418-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A220418-001AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220418-001AB1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM PHENYLBUTYRATE500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
NT6K61736TInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199369Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c564778d-b285-4d1d-a641-9d4ee76079cfAvailable on FDA.report

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium phenylbutyrateSODIUM PHENYLBUTYRATENavinta LLCc564778d-b285-4d1d-a641-9d4ee76079cf2026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 220418
application number: ANDA220418
ndc (package): 68475-011-01
ndc (product): 68475-011
ndc11 (package): 68475001101
Sodium phenylbutyrateSODIUM PHENYLBUTYRATEZydus Pharmaceuticals USA Inc.d08fd548-7eb8-4f6f-b664-b0fff6f300652026-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 220418
application number: ANDA220418

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68475-011-01684750011011 BOTTLE in 1 CARTON (68475-011-01) / 250 TABLET in 1 BOTTLE1 bottle2026-07-10NoNoCurrent