FDA.reportPublic FDA data

Neurontin

Product NDC
0071-2012
11-digit product format
000712012
Labeler code
0071
Product ID
0071-2012_e730d5df-d47b-4d7f-ae3b-bd449f6b1213
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin
Dosage form
SOLUTION
Route
ORAL
Labeler
Parke-Davis Div of Pfizer Inc
Application
NDA021129
Marketing category
NDA
Marketing start
2000-03-02
Marketing end
2027-01-31
Substance
GABAPENTIN
Active strength
250 mg/5mL
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Neurontin

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN250 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui105028, 105029, 105030, 261280, 261281, 283523, 310430, 310431, 310432, 310433, 310434, 351973

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
0071-2012-23Neurontin470 mL in 1 BOTTLE, GLASSSOLUTION47047
0071-2012-44Neurontin470 mL in 1 BOTTLESOLUTION47047
0071-2012-44Neurontin1 in 1 CARTONSOLUTION147
0071-2012-47Neurontin470 mL in 1 BOTTLE, PLASTICSOLUTION47047
0071-2012-47Neurontin1 in 1 CARTONSOLUTION147

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0071-2012-23ML - Milliliter0071-201256456e8f-b5ce-45fa-aa6d-f078bfdc1dfd12012-07-24
0071-2012-44ML - Milliliter0071-2012f44b929b-c44b-40aa-8cc6-afd8283b298c12020-02-13
0071-2012-47ML - Milliliter0071-2012515e2c9f-984f-4446-b4ec-c0daa8f5412512022-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XNEURONTIN (GABAPENTIN) CAPSULE NEURONTIN (GABAPENTIN) TABLET, FILM COATED NEURONTIN (GABAPENTIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]27
GABAPENTINACTIVE MOIETY6CW7F3G59XNEURONTIN (GABAPENTIN) CAPSULE NEURONTIN (GABAPENTIN) TABLET, FILM COATED NEURONTIN (GABAPENTIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]27
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19NEURONTIN (GABAPENTIN) CAPSULE NEURONTIN (GABAPENTIN) TABLET, FILM COATED NEURONTIN (GABAPENTIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]27
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BNEURONTIN (GABAPENTIN) CAPSULE NEURONTIN (GABAPENTIN) TABLET, FILM COATED NEURONTIN (GABAPENTIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]27
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNEURONTIN (GABAPENTIN) CAPSULE NEURONTIN (GABAPENTIN) TABLET, FILM COATED NEURONTIN (GABAPENTIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]27
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NEURONTIN (GABAPENTIN) CAPSULE NEURONTIN (GABAPENTIN) TABLET, FILM COATED NEURONTIN (GABAPENTIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]27
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNEURONTIN (GABAPENTIN) CAPSULE NEURONTIN (GABAPENTIN) TABLET, FILM COATED NEURONTIN (GABAPENTIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]27
GELATININACTIVE INGREDIENT2G86QN327LNEURONTIN (GABAPENTIN) CAPSULE NEURONTIN (GABAPENTIN) TABLET, FILM COATED NEURONTIN (GABAPENTIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]27
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNEURONTIN (GABAPENTIN) CAPSULE NEURONTIN (GABAPENTIN) TABLET, FILM COATED NEURONTIN (GABAPENTIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]27
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PNEURONTIN (GABAPENTIN) CAPSULE NEURONTIN (GABAPENTIN) TABLET, FILM COATED NEURONTIN (GABAPENTIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]27
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GNEURONTIN (GABAPENTIN) CAPSULE NEURONTIN (GABAPENTIN) TABLET, FILM COATED NEURONTIN (GABAPENTIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]27
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NEURONTIN (GABAPENTIN) CAPSULE NEURONTIN (GABAPENTIN) TABLET, FILM COATED NEURONTIN (GABAPENTIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]27
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2NEURONTIN (GABAPENTIN) CAPSULE NEURONTIN (GABAPENTIN) TABLET, FILM COATED NEURONTIN (GABAPENTIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]27
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNEURONTIN (GABAPENTIN) CAPSULE NEURONTIN (GABAPENTIN) TABLET, FILM COATED NEURONTIN (GABAPENTIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]27
TALCINACTIVE INGREDIENT7SEV7J4R1UNEURONTIN (GABAPENTIN) CAPSULE NEURONTIN (GABAPENTIN) TABLET, FILM COATED NEURONTIN (GABAPENTIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]27
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNEURONTIN (GABAPENTIN) CAPSULE NEURONTIN (GABAPENTIN) TABLET, FILM COATED NEURONTIN (GABAPENTIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]27
WATERINACTIVE INGREDIENT059QF0KO0RNEURONTIN (GABAPENTIN) CAPSULE NEURONTIN (GABAPENTIN) TABLET, FILM COATED NEURONTIN (GABAPENTIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]27
XYLITOLINACTIVE INGREDIENTVCQ006KQ1ENEURONTIN (GABAPENTIN) CAPSULE NEURONTIN (GABAPENTIN) TABLET, FILM COATED NEURONTIN (GABAPENTIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]27

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0071-2012NEURONTIN (GABAPENTIN) CAPSULE NEURONTIN (GABAPENTIN) TABLET, FILM COATED NEURONTIN (GABAPENTIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]42Current NDC, Legacy NDC, 5 package rows20241009_ee9ad9ed-6d9f-4ee1-9d7f-cfad438df388.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
283523gabapentin 250 MG in 5 mL Oral SolutionPSNee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
310431gabapentin 300 MG Oral CapsulePSNee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
310432gabapentin 400 MG Oral CapsulePSNee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
310433gabapentin 600 MG Oral TabletPSNee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
310434gabapentin 800 MG Oral TabletPSNee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
105028Neurontin 100 MG Oral CapsulePSNee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
351973Neurontin 250 MG in 5 mL Oral SolutionPSNee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
105029Neurontin 300 MG Oral CapsulePSNee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
105030Neurontin 400 MG Oral CapsulePSNee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
261280Neurontin 600 MG Oral TabletPSNee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
261281Neurontin 800 MG Oral TabletPSNee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
105028gabapentin 100 MG Oral Capsule [Neurontin]SBDee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
105029gabapentin 300 MG Oral Capsule [Neurontin]SBDee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
105030gabapentin 400 MG Oral Capsule [Neurontin]SBDee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
351973gabapentin 50 MG/ML Oral Solution [Neurontin]SBDee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
261280gabapentin 600 MG Oral Tablet [Neurontin]SBDee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
261281gabapentin 800 MG Oral Tablet [Neurontin]SBDee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
310430gabapentin 100 MG Oral CapsuleSCDee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
310431gabapentin 300 MG Oral CapsuleSCDee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
310432gabapentin 400 MG Oral CapsuleSCDee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
283523gabapentin 50 MG/ML Oral SolutionSCDee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
310433gabapentin 600 MG Oral TabletSCDee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
310434gabapentin 800 MG Oral TabletSCDee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
283523gabapentin 250 MG per 5 ML Oral SolutionSYee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
283523gabapentin 300 MG per 6 ML Oral SolutionSYee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
283523gabapentin 500 MG per 10 ML Oral SolutionSYee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
105028Neurontin 100 MG Oral CapsuleSYee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
351973Neurontin 250 MG per 5 ML Oral SolutionSYee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
105029Neurontin 300 MG Oral CapsuleSYee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
105030Neurontin 400 MG Oral CapsuleSYee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
351973Neurontin 50 MG/ML Oral SolutionSYee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
261280Neurontin 600 MG Oral TabletSYee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847
261281Neurontin 800 MG Oral TabletSYee9ad9ed-6d9f-4ee1-9d7f-cfad438df38847

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0071-2012-2300071201223470 mL in 1 BOTTLE, GLASS (0071-2012-23) 470 ml2000-03-020000-00-00NoNoCurrent
0071-2012-44000712012441 BOTTLE in 1 CARTON (0071-2012-44) > 470 mL in 1 BOTTLE1 bottle2020-01-210000-00-00NoNoCurrent
0071-2012-47000712012471 BOTTLE, PLASTIC in 1 CARTON (0071-2012-47) / 470 mL in 1 BOTTLE, PLASTIC2022-07-122027-01-31NoNoCurrent