FDA.reportPublic FDA data

Gaba 300-EZS

Product NDC
59088-725
Requested package NDC
59088-725-00
11-digit product format
590880725
Labeler code
59088
Product ID
59088-725_b43e4780-f902-89d9-e053-2a95a90a6792
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
KIT
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-10-22
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage59088-72559088-725-00EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…

Additional Listing Data#

Finished product
Yes
Brand name base
Gaba 300-EZS
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310431Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bb29692e-1546-4d05-a46a-93baf4172c7dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45963-556-11Gaba 300-EZS100 in 1 BOTTLECAPSULE100300 mg4
59088-725-00Gaba 300-EZS1 in 1 KITKIT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-725GABA 300-EZS (GABAPENTIN) KIT [PURETEK CORPORATION]4Current NDC, Legacy NDC, 2 package rows20201117_bb29692e-1546-4d05-a46a-93baf4172c7d.zip

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gaba 300-EZSGABAPENTINPureTek Corporationbb29692e-1546-4d05-a46a-93baf4172c7d2020-11-16Warnings, Adverse reactionsExact identifier
ndc (package): 59088-725-00
ndc (product): 59088-725
ndc11 (package): 59088072500

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSNbb29692e-1546-4d05-a46a-93baf4172c7d4
310431gabapentin 300 MG Oral CapsuleSCDbb29692e-1546-4d05-a46a-93baf4172c7d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59088-725-00590880725001 KIT in 1 KIT (59088-725-00) * 100 CAPSULE in 1 BOTTLE (45963-556-11) 1 kit2018-10-220000-00-00NoNoCurrent