FDA.reportPublic FDA data

Gabapentin

Product NDC
71335-0220
11-digit product format
713350220
Labeler code
71335
Product ID
71335-0220_bce0f9d7-f30d-4462-a8d3-54dd18947a8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078428
Marketing category
ANDA
Marketing start
2009-11-24
Substance
GABAPENTIN
Active strength
300 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
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
71335-0220-0Gabapentin20 in 1 BOTTLECAPSULE20102
71335-0220-1Gabapentin30 in 1 BOTTLECAPSULE30102
71335-0220-2Gabapentin90 in 1 BOTTLECAPSULE90102
71335-0220-3Gabapentin60 in 1 BOTTLECAPSULE60102
71335-0220-4Gabapentin120 in 1 BOTTLECAPSULE120102
71335-0220-5Gabapentin100 in 1 BOTTLECAPSULE100102
71335-0220-6Gabapentin28 in 1 BOTTLECAPSULE28102
71335-0220-7Gabapentin112 in 1 BOTTLECAPSULE112102
71335-0220-8Gabapentin84 in 1 BOTTLECAPSULE84102
71335-0220-9Gabapentin180 in 1 BOTTLECAPSULE180102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0220-0EA - Each71335-0220222faaa0-e0b0-4bc7-9936-cad26dbbe05f12020-09-14
71335-0220-1EA - Each71335-0220d1be7767-516e-4f23-9ee8-30993cfc9f6e12018-05-09
71335-0220-2EA - Each71335-02209b4cb1b0-375a-4e1e-a7bb-ecdd546b6ca212018-05-09
71335-0220-3EA - Each71335-0220bf1e474a-9c86-40fd-9a56-525b5eedbc7012018-05-09
71335-0220-4EA - Each71335-02200f74bf40-0edd-430c-b54b-9c629c5ebcb512018-05-09
71335-0220-5EA - Each71335-0220ceaeb334-b6ac-4b1c-89da-2701d440744f12020-09-14
71335-0220-8EA - Each71335-0220e1cf3864-7a53-4fda-9f44-6dcd339695ab12020-09-14
71335-0220-9EA - Each71335-02204ed45fc0-6d83-4569-b947-e1f49ca2571d12018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0220GABAPENTIN CAPSULE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 10 package rows20241109_a15d5dcc-63c4-4c06-ab91-5e22cdf234cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSNa15d5dcc-63c4-4c06-ab91-5e22cdf234cc102
310431gabapentin 300 MG Oral CapsuleSCDa15d5dcc-63c4-4c06-ab91-5e22cdf234cc102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0220-07133502200020 CAPSULE in 1 BOTTLE (71335-0220-0) 20 capsule2019-04-250000-00-00NoNoCurrent
71335-0220-17133502200130 CAPSULE in 1 BOTTLE (71335-0220-1) 30 capsule2018-03-210000-00-00NoNoCurrent
71335-0220-27133502200290 CAPSULE in 1 BOTTLE (71335-0220-2) 90 capsule2018-03-160000-00-00NoNoCurrent
71335-0220-37133502200360 CAPSULE in 1 BOTTLE (71335-0220-3) 60 capsule2018-03-230000-00-00NoNoCurrent
71335-0220-471335022004120 CAPSULE in 1 BOTTLE (71335-0220-4) 120 capsule2018-03-050000-00-00NoNoCurrent
71335-0220-571335022005100 CAPSULE in 1 BOTTLE (71335-0220-5) 100 capsule2018-03-120000-00-00NoNoCurrent
71335-0220-67133502200628 CAPSULE in 1 BOTTLE (71335-0220-6) 28 capsule2024-10-300000-00-00NoNoCurrent
71335-0220-771335022007112 CAPSULE in 1 BOTTLE (71335-0220-7) 112 capsule2024-10-300000-00-00NoNoCurrent
71335-0220-87133502200884 CAPSULE in 1 BOTTLE (71335-0220-8) 84 capsule2018-04-030000-00-00NoNoCurrent
71335-0220-971335022009180 CAPSULE in 1 BOTTLE (71335-0220-9) 180 capsule2018-02-210000-00-00NoNoCurrent