FDA.reportPublic FDA data

Gabapentin

Product NDC
70518-0293
11-digit product format
705180293
Labeler code
70518
Product ID
70518-0293_4cea228c-c9cb-1ec0-e063-6294a90a81de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090858
Marketing category
ANDA
Marketing start
2017-03-08
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
70518-0293-0Gabapentin90 in 1 BOTTLE, PLASTICCAPSULE9028
70518-0293-1Gabapentin270 in 1 BOTTLE, PLASTICCAPSULE27028
70518-0293-2Gabapentin120 in 1 BOTTLE, PLASTICCAPSULE12028
70518-0293-3Gabapentin28 in 1 BLISTER PACKCAPSULE2828
70518-0293-4Gabapentin180 in 1 BOTTLE, PLASTICCAPSULE18028
70518-0293-5Gabapentin60 in 1 BOTTLE, PLASTICCAPSULE6028
70518-0293-6Gabapentin30 in 1 BLISTER PACKCAPSULE3028

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN3e633cd0-5ee8-4a05-bcfc-0a80209bf27f28
310431gabapentin 300 MG Oral CapsuleSCD3e633cd0-5ee8-4a05-bcfc-0a80209bf27f28

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0293-07051802930090 CAPSULE in 1 BOTTLE, PLASTIC (70518-0293-0) 90 capsule2017-03-080000-00-00NoNoCurrent
70518-0293-170518029301270 CAPSULE in 1 BOTTLE, PLASTIC (70518-0293-1) 270 capsule2017-07-120000-00-00NoNoCurrent
70518-0293-270518029302120 CAPSULE in 1 BOTTLE, PLASTIC (70518-0293-2) 120 capsule2017-07-060000-00-00NoNoCurrent
70518-0293-37051802930328 CAPSULE in 1 BLISTER PACK (70518-0293-3) 28 capsule2018-09-170000-00-00NoNoCurrent
70518-0293-470518029304180 CAPSULE in 1 BOTTLE, PLASTIC (70518-0293-4) 180 capsule2020-02-270000-00-00NoNoCurrent
70518-0293-57051802930560 CAPSULE in 1 BOTTLE, PLASTIC (70518-0293-5) 60 capsule2020-03-060000-00-00NoNoCurrent
70518-0293-67051802930630 CAPSULE in 1 BLISTER PACK (70518-0293-6) 30 capsule2020-04-200000-00-00NoNoCurrent