FDA.reportPublic FDA data

Gabapentin

Product NDC
50383-351
Requested package NDC
50383-351-09
11-digit product format
503830351
Labeler code
50383
Product ID
50383-351_8e0e9c86-81df-42e4-a6b2-252e94095666
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
SOLUTION
Route
ORAL
Labeler
Akorn
Application
ANDA078974
Marketing category
ANDA
Marketing start
2011-02-23
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
250 mg/5mL
Pharmacologic classes
Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50383-35150383-351-09IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A078974-001GABAPENTINGABAPENTIN250MG/5MLSOLUTION / ORALAA2011-02-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078974-001AA

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
2026-08-01 22:54:322026-06A078974-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2011-02-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078974-001AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINBioComp Pharma, Inc.0b3a4009-42f3-c84f-e063-6294a90a80682025-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078974
application number: ANDA078974

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50383-351-092024-01-30C16284748780-11030e365-6b0c-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GABAPENTIN ORAL SOLUTION safely and effectively. See full prescribing information for GABAPENTIN ORAL SOLUTION. GABAPENTIN oral solution Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50383-351-06Gabapentin6 mL in 1 CUP, UNIT-DOSESOLUTION621
50383-351-09Gabapentin4 in 1 CASESOLUTION421
50383-351-09Gabapentin10 in 1 TRAYSOLUTION1021

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN SOLUTION [HI-TECH PHARMACAL CO., INC.]14
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN SOLUTION [HI-TECH PHARMACAL CO., INC.]14
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PGABAPENTIN SOLUTION [HI-TECH PHARMACAL CO., INC.]14
GLYCERININACTIVE INGREDIENTPDC6A3C0OXGABAPENTIN SOLUTION [HI-TECH PHARMACAL CO., INC.]14
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BGABAPENTIN SOLUTION [HI-TECH PHARMACAL CO., INC.]14
WATERINACTIVE INGREDIENT059QF0KO0RGABAPENTIN SOLUTION [HI-TECH PHARMACAL CO., INC.]14
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EGABAPENTIN SOLUTION [HI-TECH PHARMACAL CO., INC.]14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-351GABAPENTIN SOLUTION [AKORN]21Legacy NDC, 3 package rows20220315_c64c09c9-0567-4a4f-b2c6-8f667986c9af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283523gabapentin 250 MG in 5 mL Oral SolutionPSNc64c09c9-0567-4a4f-b2c6-8f667986c9af21
283523gabapentin 50 MG/ML Oral SolutionSCDc64c09c9-0567-4a4f-b2c6-8f667986c9af21
283523gabapentin 250 MG per 5 ML Oral SolutionSYc64c09c9-0567-4a4f-b2c6-8f667986c9af21
283523gabapentin 300 MG per 6 ML Oral SolutionSYc64c09c9-0567-4a4f-b2c6-8f667986c9af21
283523gabapentin 500 MG per 10 ML Oral SolutionSYc64c09c9-0567-4a4f-b2c6-8f667986c9af21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-351-09503830351094 TRAY in 1 CASE (50383-351-09) > 10 CUP, UNIT-DOSE in 1 TRAY > 6 mL in 1 CUP, UNIT-DOSE (50383-351-06) 4 tray2021-05-250000-00-00NoNoCurrent