FDA.reportPublic FDA data

Gabapentin

Product NDC
60760-740
11-digit product format
607600740
Labeler code
60760
Product ID
60760-740_50c46580-8fe5-4562-e063-6394a90aae06
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
ANDA204989
Marketing category
ANDA
Marketing start
2020-12-31
Substance
GABAPENTIN
Active strength
100 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
GABAPENTIN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310430

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
60760-740-60Gabapentin60 in 1 BOTTLE, PLASTICCAPSULE603
60760-740-90Gabapentin90 in 1 BOTTLE, PLASTICCAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-740-60EA - Each60760-74092548b25-0ca9-4205-bdde-c824f0f5aa4b12021-04-08
60760-740-90EA - Each60760-7400639b8e8-476b-4751-8585-7185c593856912021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-740GABAPENTIN CAPSULE [ST. MARY'S MEDICAL PARK PHARMACY]2Current NDC, Legacy NDC, 2 package rows20210326_b8b7e045-a7fe-8539-e053-2a95a90a40f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNb8b7e045-a7fe-8539-e053-2a95a90a40f83
310430gabapentin 100 MG Oral CapsuleSCDb8b7e045-a7fe-8539-e053-2a95a90a40f83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60760-740-606076007406060 CAPSULE in 1 BOTTLE, PLASTIC (60760-740-60) 60 capsule2021-03-110000-00-00NoNoCurrent
60760-740-906076007409090 CAPSULE in 1 BOTTLE, PLASTIC (60760-740-90) 90 capsule2020-12-310000-00-00NoNoCurrent