Gabapentin

Product NDC
69097-812
11-digit product format
690970812
Labeler code
69097
Product ID
69097-812_69887d93-de9a-4397-a629-a0ce8e62c69a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA202764
Marketing category
ANDA
Marketing start
2016-07-22
Substance
GABAPENTIN
Active strength
600 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], 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
GABAPENTIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310433, 310434

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-812-02Gabapentin30 in 1 BOTTLETABLET306
69097-812-07Gabapentin100 in 1 BOTTLETABLET1006
69097-812-12Gabapentin500 in 1 BOTTLETABLET5006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-812GABAPENTIN TABLET [CIPLA USA INC.]6Current NDC, Legacy NDC, 3 package rows20230121_7c3ac86f-b8f7-42bf-942a-db854d946e54.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN7c3ac86f-b8f7-42bf-942a-db854d946e546
310434gabapentin 800 MG Oral TabletPSN7c3ac86f-b8f7-42bf-942a-db854d946e546
310433gabapentin 600 MG Oral TabletSCD7c3ac86f-b8f7-42bf-942a-db854d946e546
310434gabapentin 800 MG Oral TabletSCD7c3ac86f-b8f7-42bf-942a-db854d946e546
310433gabapentin 600 MG Oral TabletPSN3b4fc24e-bf30-7203-e054-00144ff8d46c4
310433gabapentin 600 MG Oral TabletSCD3b4fc24e-bf30-7203-e054-00144ff8d46c4
310433gabapentin 600 MG Oral TabletPSNf6baeb5c-ca9c-4730-aeb8-8f8732e8ca3a3
310433gabapentin 600 MG Oral TabletSCDf6baeb5c-ca9c-4730-aeb8-8f8732e8ca3a3
310433gabapentin 600 MG Oral TabletPSNd9f836d6-4442-4d31-a47a-14a744574c8c2
310433gabapentin 600 MG Oral TabletSCDd9f836d6-4442-4d31-a47a-14a744574c8c2
310433gabapentin 600 MG Oral TabletPSN5a05a77b-ab0d-d3f8-e053-2a91aa0a906f1
310434gabapentin 800 MG Oral TabletPSN5a05a77b-ab0d-d3f8-e053-2a91aa0a906f1
310433gabapentin 600 MG Oral TabletSCD5a05a77b-ab0d-d3f8-e053-2a91aa0a906f1
310434gabapentin 800 MG Oral TabletSCD5a05a77b-ab0d-d3f8-e053-2a91aa0a906f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-812-026909708120230 TABLET in 1 BOTTLE (69097-812-02) 30 tablet2016-07-220000-00-00NoNoCurrent
69097-812-0769097081207100 TABLET in 1 BOTTLE (69097-812-07) 100 tablet2016-07-220000-00-00NoNoCurrent
69097-812-1269097081212500 TABLET in 1 BOTTLE (69097-812-12) 500 tablet2016-07-220000-00-00NoNoCurrent