FDA.reportPublic FDA data

Gabapentin

Product NDC
85509-2180
11-digit product format
855092180
Labeler code
85509
Product ID
85509-2180_4f95c02c-a801-c923-e063-6394a90a009e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
PHOENIX RX LLC
Application
ANDA204989
Marketing category
ANDA
Marketing start
2016-02-18
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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85509-2180-1Gabapentin100 in 1 BOTTLE, PLASTICCAPSULE1001
85509-2180-3Gabapentin30 in 1 BOTTLE, PLASTICCAPSULE301
85509-2180-6Gabapentin60 in 1 BOTTLE, PLASTICCAPSULE601
85509-2180-9Gabapentin90 in 1 BOTTLE, PLASTICCAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85509-2180-1EA - Each85509-218073668aff-8ea4-4bec-8d99-c4b276334b3612026-05-22
85509-2180-3EA - Each85509-21807b30ca01-edae-43e5-b37f-8f96c66f47e912026-05-22
85509-2180-6EA - Each85509-2180a0f5ddba-b6cc-4f39-926c-9281ec8f2a5d12026-05-22
85509-2180-9EA - Each85509-2180e4c8889d-8c1c-42f2-8774-1ec3b8c11b8e12026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN4f95c01f-200e-bfd7-e063-6394a90abc381
310431gabapentin 300 MG Oral CapsuleSCD4f95c01f-200e-bfd7-e063-6394a90abc381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85509-2180-185509218001100 CAPSULE in 1 BOTTLE, PLASTIC (85509-2180-1) 100 capsule2026-04-16NoNoHistorical
85509-2180-38550921800330 CAPSULE in 1 BOTTLE, PLASTIC (85509-2180-3) 30 capsule2026-04-16NoNoHistorical
85509-2180-68550921800660 CAPSULE in 1 BOTTLE, PLASTIC (85509-2180-6) 60 capsule2026-04-16NoNoHistorical
85509-2180-98550921800990 CAPSULE in 1 BOTTLE, PLASTIC (85509-2180-9) 90 capsule2026-04-16NoNoHistorical