FDA.reportPublic FDA data

Gabapentin

Product NDC
68788-7848
11-digit product format
687887848
Labeler code
68788
Product ID
68788-7848_f67d9eb0-b6cd-45b7-8ce0-96a85c30d1c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA204989
Marketing category
ANDA
Marketing start
2021-01-22
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
68788-7848-0Gabapentin100 in 1 BOTTLE, PLASTICCAPSULE1004
68788-7848-1Gabapentin180 in 1 BOTTLE, PLASTICCAPSULE1804
68788-7848-3Gabapentin30 in 1 BOTTLE, PLASTICCAPSULE304
68788-7848-5Gabapentin15 in 1 BOTTLE, PLASTICCAPSULE154
68788-7848-6Gabapentin60 in 1 BOTTLE, PLASTICCAPSULE604
68788-7848-8Gabapentin120 in 1 BOTTLE, PLASTICCAPSULE1204
68788-7848-9Gabapentin90 in 1 BOTTLE, PLASTICCAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7848-0EA - Each68788-7848793cf1e1-7786-4213-9905-c0a4460db28312021-03-02
68788-7848-1EA - Each68788-78484bf747aa-bba8-49ea-9f05-700a8485b68a12021-03-02
68788-7848-3EA - Each68788-784839699adc-eb3d-47b0-98af-0bbb2a19a2cd12021-03-02
68788-7848-5EA - Each68788-7848f4ff6de4-60f7-4df3-aea1-5e6d2b4f749312021-03-02
68788-7848-6EA - Each68788-784896425a0b-faa9-4db1-b8a3-9cf26c88e4f812021-03-02
68788-7848-8EA - Each68788-78489fdc304b-7942-4d30-a0c3-437be0c321af12021-03-02
68788-7848-9EA - Each68788-78483e371f6e-82db-4d1e-8751-64f3559d2a3b12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7848GABAPENTIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 7 package rows20240112_bff3beea-1f05-4e84-bcd2-d05782acddae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSNbff3beea-1f05-4e84-bcd2-d05782acddae4
310431gabapentin 300 MG Oral CapsuleSCDbff3beea-1f05-4e84-bcd2-d05782acddae4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7848-068788784800100 CAPSULE in 1 BOTTLE, PLASTIC (68788-7848-0) 100 capsule2021-01-220000-00-00NoNoCurrent
68788-7848-168788784801180 CAPSULE in 1 BOTTLE, PLASTIC (68788-7848-1) 180 capsule2021-01-220000-00-00NoNoCurrent
68788-7848-36878878480330 CAPSULE in 1 BOTTLE, PLASTIC (68788-7848-3) 30 capsule2021-01-220000-00-00NoNoCurrent
68788-7848-56878878480515 CAPSULE in 1 BOTTLE, PLASTIC (68788-7848-5) 15 capsule2021-01-220000-00-00NoNoCurrent
68788-7848-66878878480660 CAPSULE in 1 BOTTLE, PLASTIC (68788-7848-6) 60 capsule2021-01-220000-00-00NoNoCurrent
68788-7848-868788784808120 CAPSULE in 1 BOTTLE, PLASTIC (68788-7848-8) 120 capsule2021-01-220000-00-00NoNoCurrent
68788-7848-96878878480990 CAPSULE in 1 BOTTLE, PLASTIC (68788-7848-9) 90 capsule2021-01-220000-00-00NoNoCurrent