FDA.reportPublic FDA data

Gabapentin

Product NDC
16714-661
11-digit product format
167140661
Labeler code
16714
Product ID
16714-661_2f6c168b-aaf3-4a6a-b8a0-5be6b5f81d7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA078787
Marketing category
ANDA
Marketing start
2008-01-31
Substance
GABAPENTIN
Active strength
100 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gabapentin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310430, 310431, 310432

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
16714-661-01Gabapentin100 in 1 BOTTLECAPSULE10019
16714-661-02Gabapentin500 in 1 BOTTLECAPSULE50019
16714-661-03Gabapentin1000 in 1 BOTTLECAPSULE100019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-661-01EA - Each16714-6610b0222bd-3df4-4f51-b1d2-4aa435c6195512012-07-24
16714-661-02EA - Each16714-661f21464d3-22f4-43ac-96c6-05b77e4bcb1d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [NORTHSTAR RX LLC]7
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [NORTHSTAR RX LLC]7
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GABAPENTIN CAPSULE [NORTHSTAR RX LLC]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGABAPENTIN CAPSULE [NORTHSTAR RX LLC]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GABAPENTIN CAPSULE [NORTHSTAR RX LLC]7
GELATININACTIVE INGREDIENT2G86QN327LGABAPENTIN CAPSULE [NORTHSTAR RX LLC]7
SHELLACINACTIVE INGREDIENT46N107B71OGABAPENTIN CAPSULE [NORTHSTAR RX LLC]7
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGABAPENTIN CAPSULE [NORTHSTAR RX LLC]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [NORTHSTAR RX LLC]7
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN CAPSULE [NORTHSTAR RX LLC]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [NORTHSTAR RX LLC]7
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LGABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OGABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-661GABAPENTIN CAPSULE [NORTHSTAR RX LLC]18Current NDC, Legacy NDC, 3 package rows20241115_f7c1fd34-d615-43a2-8989-898fe11f90df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNf7c1fd34-d615-43a2-8989-898fe11f90df19
310431gabapentin 300 MG Oral CapsulePSNf7c1fd34-d615-43a2-8989-898fe11f90df19
310432gabapentin 400 MG Oral CapsulePSNf7c1fd34-d615-43a2-8989-898fe11f90df19
310430gabapentin 100 MG Oral CapsuleSCDf7c1fd34-d615-43a2-8989-898fe11f90df19
310431gabapentin 300 MG Oral CapsuleSCDf7c1fd34-d615-43a2-8989-898fe11f90df19
310432gabapentin 400 MG Oral CapsuleSCDf7c1fd34-d615-43a2-8989-898fe11f90df19
310430gabapentin 100 MG Oral CapsulePSNd25daaac-a8ab-4f12-acc2-4ec8fc97a2d414
310432gabapentin 400 MG Oral CapsulePSNd25daaac-a8ab-4f12-acc2-4ec8fc97a2d414
310430gabapentin 100 MG Oral CapsuleSCDd25daaac-a8ab-4f12-acc2-4ec8fc97a2d414
310432gabapentin 400 MG Oral CapsuleSCDd25daaac-a8ab-4f12-acc2-4ec8fc97a2d414
310430gabapentin 100 MG Oral CapsulePSNbc08e35d-ef5d-1dcd-e053-2a95a90ab5de7
310430gabapentin 100 MG Oral CapsuleSCDbc08e35d-ef5d-1dcd-e053-2a95a90ab5de7
310430gabapentin 100 MG Oral CapsulePSN67330eef-c976-4862-b1ae-20f30f43df765
310430gabapentin 100 MG Oral CapsuleSCD67330eef-c976-4862-b1ae-20f30f43df765
310430gabapentin 100 MG Oral CapsulePSN7e351770-8975-4417-a599-feaa3cba75141
310430gabapentin 100 MG Oral CapsuleSCD7e351770-8975-4417-a599-feaa3cba75141

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-661-0116714066101100 CAPSULE in 1 BOTTLE (16714-661-01) 100 capsule2008-01-310000-00-00NoNoCurrent
16714-661-0216714066102500 CAPSULE in 1 BOTTLE (16714-661-02) 500 capsule2008-01-310000-00-00NoNoCurrent
16714-661-03167140661031000 CAPSULE in 1 BOTTLE (16714-661-03) 1000 capsule2008-01-310000-00-00NoNoCurrent