GABAPENTIN

Product NDC
69097-943
11-digit product format
690970943
Labeler code
69097
Product ID
69097-943_fdeea2da-e306-45d8-a27a-e8be090319ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA090705
Marketing category
ANDA
Marketing start
2017-12-05
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
Rxcui310430, 310431, 310432

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
69097-943-07GABAPENTIN100 in 1 BOTTLECAPSULE1008
69097-943-12GABAPENTIN500 in 1 BOTTLECAPSULE5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-943-07EA - Each69097-94399a70ea2-8ae3-4c2b-bddd-f0f4d2d2a55112018-01-12
69097-943-12EA - Each69097-9430e0721bd-8fbc-4995-9192-32d7a47e39c512018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-943GABAPENTIN CAPSULE [CIPLA USA INC.]7Current NDC, Legacy NDC, 2 package rows20241115_9e4eca9c-6a2c-4ede-a252-1a27094bf594.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN6e7f602a-2c5f-4651-a228-5fc5bf249205101
310431gabapentin 300 MG Oral CapsuleSCD6e7f602a-2c5f-4651-a228-5fc5bf249205101
310431gabapentin 300 MG Oral CapsulePSN1fd95278-842f-4bf9-abd5-4d9aa858d36d10
310431gabapentin 300 MG Oral CapsuleSCD1fd95278-842f-4bf9-abd5-4d9aa858d36d10
310430gabapentin 100 MG Oral CapsulePSN9e4eca9c-6a2c-4ede-a252-1a27094bf5948
310431gabapentin 300 MG Oral CapsulePSN9e4eca9c-6a2c-4ede-a252-1a27094bf5948
310431gabapentin 300 MG Oral CapsulePSN96cab001-3d67-17f7-e053-2a95a90a2e238
310432gabapentin 400 MG Oral CapsulePSN9e4eca9c-6a2c-4ede-a252-1a27094bf5948
310430gabapentin 100 MG Oral CapsuleSCD9e4eca9c-6a2c-4ede-a252-1a27094bf5948
310431gabapentin 300 MG Oral CapsuleSCD96cab001-3d67-17f7-e053-2a95a90a2e238
310431gabapentin 300 MG Oral CapsuleSCD9e4eca9c-6a2c-4ede-a252-1a27094bf5948
310432gabapentin 400 MG Oral CapsuleSCD9e4eca9c-6a2c-4ede-a252-1a27094bf5948
310430gabapentin 100 MG Oral CapsulePSN2e319a08-901d-40a9-e054-00144ff88e883
310431gabapentin 300 MG Oral CapsulePSN2e319a08-901d-40a9-e054-00144ff88e883
310434gabapentin 800 MG Oral TabletPSN2e319a08-901d-40a9-e054-00144ff88e883
310430gabapentin 100 MG Oral CapsuleSCD2e319a08-901d-40a9-e054-00144ff88e883
310431gabapentin 300 MG Oral CapsuleSCD2e319a08-901d-40a9-e054-00144ff88e883
310434gabapentin 800 MG Oral TabletSCD2e319a08-901d-40a9-e054-00144ff88e883
310431gabapentin 300 MG Oral CapsulePSN45039bba-7a96-450c-95be-83a3aa4fcbd21
310431gabapentin 300 MG Oral CapsuleSCD45039bba-7a96-450c-95be-83a3aa4fcbd21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-943-0769097094307100 CAPSULE in 1 BOTTLE (69097-943-07) 100 capsule2017-12-050000-00-00NoNoCurrent
69097-943-1269097094312500 CAPSULE in 1 BOTTLE (69097-943-12) 500 capsule2017-12-050000-00-00NoNoCurrent