FDA.reportPublic FDA data

Gabapentin

Product NDC
70518-1760
11-digit product format
705181760
Labeler code
70518
Product ID
70518-1760_4db14d4f-eb37-768e-e063-6294a90a5730
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090858
Marketing category
ANDA
Marketing start
2019-01-01
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
70518-1760-0Gabapentin30 in 1 BLISTER PACKCAPSULE3019
70518-1760-1Gabapentin90 in 1 BOTTLE, PLASTICCAPSULE9019
70518-1760-2Gabapentin60 in 1 BOTTLE, PLASTICCAPSULE6019
70518-1760-3Gabapentin30 in 1 BOTTLE, PLASTICCAPSULE3019
70518-1760-4Gabapentin30 in 1 BLISTER PACKCAPSULE3019
70518-1760-5Gabapentin60 in 1 BOTTLE, PLASTICCAPSULE6019
70518-1760-6Gabapentin90 in 1 BOTTLE, PLASTICCAPSULE9019
70518-1760-7Gabapentin180 in 1 BOTTLE, PLASTICCAPSULE18019
70518-1760-8Gabapentin120 in 1 BOTTLE, PLASTICCAPSULE12019
70518-1760-9Gabapentin30 in 1 BOTTLE, PLASTICCAPSULE3019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-1760-6EA - Each70518-1760da011682-68b5-4905-9334-9a4c18f88dc512026-01-08
70518-1760-8EA - Each70518-17602f72ec2d-9291-4c1e-a1de-23423d7c15e612026-01-08
70518-1760-9EA - Each70518-176027c5fd9b-6a24-4b61-87b8-f38a485f487712025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1760GABAPENTIN CAPSULE [REMEDYREPACK INC.]15Current NDC, Legacy NDC, 10 package rows20250228_d06380d0-c894-427e-b13e-5a8f9eb86a34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSNd06380d0-c894-427e-b13e-5a8f9eb86a3419
310431gabapentin 300 MG Oral CapsuleSCDd06380d0-c894-427e-b13e-5a8f9eb86a3419

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1760-07051817600030 CAPSULE in 1 BLISTER PACK (70518-1760-0) 30 capsule2019-01-010000-00-00NoNoCurrent
70518-1760-17051817600190 CAPSULE in 1 BOTTLE, PLASTIC (70518-1760-1) 90 capsule2020-03-100000-00-00NoNoCurrent
70518-1760-27051817600260 CAPSULE in 1 BOTTLE, PLASTIC (70518-1760-2) 60 capsule2020-03-260000-00-00NoNoCurrent
70518-1760-37051817600330 CAPSULE in 1 BOTTLE, PLASTIC (70518-1760-3) 30 capsule2020-07-280000-00-00NoNoCurrent
70518-1760-47051817600430 CAPSULE in 1 BLISTER PACK (70518-1760-4) 30 capsule2021-08-060000-00-00NoNoCurrent
70518-1760-57051817600560 CAPSULE in 1 BOTTLE, PLASTIC (70518-1760-5) 60 capsule2021-08-170000-00-00NoNoCurrent
70518-1760-67051817600690 CAPSULE in 1 BOTTLE, PLASTIC (70518-1760-6) 90 capsule2021-10-080000-00-00NoNoCurrent
70518-1760-770518176007180 CAPSULE in 1 BOTTLE, PLASTIC (70518-1760-7) 180 capsule2021-10-180000-00-00NoNoCurrent
70518-1760-870518176008120 CAPSULE in 1 BOTTLE, PLASTIC (70518-1760-8) 120 capsule2021-11-010000-00-00NoNoCurrent
70518-1760-97051817600930 CAPSULE in 1 BOTTLE, PLASTIC (70518-1760-9) 30 capsule2021-12-290000-00-00NoNoCurrent