FDA.reportPublic FDA data

Gabapentin

Product NDC
60760-743
11-digit product format
607600743
Labeler code
60760
Product ID
60760-743_4cc2451c-7b64-08ac-e063-6394a90a45a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
ANDA205101
Marketing category
ANDA
Marketing start
2021-01-28
Substance
GABAPENTIN
Active strength
600 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
GABAPENTIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310433

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
60760-743-30Gabapentin30 in 1 BOTTLE, PLASTICTABLET304
60760-743-60Gabapentin60 in 1 BOTTLE, PLASTICTABLET604
60760-743-90Gabapentin90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-743-30EA - Each60760-74307a91834-d3d8-491f-b1cf-5c84f6a9bc1a12026-04-20
60760-743-60EA - Each60760-7432314bc00-ede4-44a7-8b1c-37c2c1bba2ce12026-04-20
60760-743-90EA - Each60760-743a30a9cd6-567d-4cb2-9bfc-da23db1e363b12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-743GABAPENTIN TABLET [ST. MARY'S MEDICAL PARK PHARMACY]2Current NDC, Legacy NDC, 3 package rows20230107_ba4d863d-be38-8cf5-e053-2995a90a69fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSNba4d863d-be38-8cf5-e053-2995a90a69fb4
310433gabapentin 600 MG Oral TabletSCDba4d863d-be38-8cf5-e053-2995a90a69fb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60760-743-306076007433030 TABLET in 1 BOTTLE, PLASTIC (60760-743-30) 30 tablet2026-03-16NoNoHistorical
60760-743-606076007436060 TABLET in 1 BOTTLE, PLASTIC (60760-743-60) 60 tablet2026-03-16NoNoHistorical
60760-743-906076007439090 TABLET in 1 BOTTLE, PLASTIC (60760-743-90) 90 tablet2021-01-280000-00-00NoNoCurrent