FDA.reportPublic FDA data

GABAPENTIN

Product NDC
71335-1997
11-digit product format
713351997
Labeler code
71335
Product ID
71335-1997_8b321864-f57b-49e4-8eb0-748af0b2b96f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075360
Marketing category
ANDA
Marketing start
2020-09-07
Substance
GABAPENTIN
Active strength
300 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310431

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1997-0GABAPENTIN20 in 1 BOTTLECAPSULE20104
71335-1997-1GABAPENTIN30 in 1 BOTTLECAPSULE30104
71335-1997-2GABAPENTIN90 in 1 BOTTLECAPSULE90104
71335-1997-3GABAPENTIN60 in 1 BOTTLECAPSULE60104
71335-1997-4GABAPENTIN120 in 1 BOTTLECAPSULE120104
71335-1997-5GABAPENTIN100 in 1 BOTTLECAPSULE100104
71335-1997-6GABAPENTIN28 in 1 BOTTLECAPSULE28104
71335-1997-7GABAPENTIN112 in 1 BOTTLECAPSULE112104
71335-1997-8GABAPENTIN84 in 1 BOTTLECAPSULE84104
71335-1997-9GABAPENTIN180 in 1 BOTTLECAPSULE180104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1997-1EA - Each71335-199728b086d3-4795-41d6-9e1b-95d328f7cd5d12025-05-14
71335-1997-2EA - Each71335-199783175232-57ed-4c9b-bc20-7169d34b7dc012022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1997GABAPENTIN CAPSULE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 10 package rows20231129_397fd6d3-317b-4b61-a52b-3a09ca1d88a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN397fd6d3-317b-4b61-a52b-3a09ca1d88a4104
310431gabapentin 300 MG Oral CapsuleSCD397fd6d3-317b-4b61-a52b-3a09ca1d88a4104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1997-07133519970020 CAPSULE in 1 BOTTLE (71335-1997-0) 20 capsule2022-02-100000-00-00NoNoCurrent
71335-1997-17133519970130 CAPSULE in 1 BOTTLE (71335-1997-1) 30 capsule2022-02-100000-00-00NoNoCurrent
71335-1997-27133519970290 CAPSULE in 1 BOTTLE (71335-1997-2) 90 capsule2022-02-100000-00-00NoNoCurrent
71335-1997-37133519970360 CAPSULE in 1 BOTTLE (71335-1997-3) 60 capsule2022-02-100000-00-00NoNoCurrent
71335-1997-471335199704120 CAPSULE in 1 BOTTLE (71335-1997-4) 120 capsule2022-02-100000-00-00NoNoCurrent
71335-1997-571335199705100 CAPSULE in 1 BOTTLE (71335-1997-5) 100 capsule2022-02-100000-00-00NoNoCurrent
71335-1997-67133519970628 CAPSULE in 1 BOTTLE (71335-1997-6) 28 capsule2022-02-100000-00-00NoNoCurrent
71335-1997-771335199707112 CAPSULE in 1 BOTTLE (71335-1997-7) 112 capsule2022-02-100000-00-00NoNoCurrent
71335-1997-87133519970884 CAPSULE in 1 BOTTLE (71335-1997-8) 84 capsule2022-02-100000-00-00NoNoCurrent
71335-1997-971335199709180 CAPSULE in 1 BOTTLE (71335-1997-9) 180 capsule2022-02-100000-00-00NoNoCurrent