FDA.reportPublic FDA data

Gabapentin

Product NDC
76420-234
11-digit product format
764200234
Labeler code
76420
Product ID
76420-234_e35b53ce-ead2-6007-e053-2995a90a7f25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA090858
Marketing category
ANDA
Marketing start
2011-01-29
Substance
GABAPENTIN
Active strength
400 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
GABAPENTIN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310431, 310432

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-234-12Gabapentin120 in 1 BOTTLECAPSULE1202
76420-234-24Gabapentin240 in 1 BOTTLECAPSULE2402
76420-234-30Gabapentin30 in 1 BOTTLECAPSULE302
76420-234-60Gabapentin60 in 1 BOTTLECAPSULE602
76420-234-90Gabapentin90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-234-12EA - Each76420-2340eabcbd2-6760-4cb7-9389-c7a5810d8c5712022-08-04
76420-234-24EA - Each76420-234415eeeec-6582-4f49-9527-9cc390a6fe9212022-08-04
76420-234-30EA - Each76420-23419abcc4b-a6bb-4dae-bf03-3cf3d7fec50d12022-08-04
76420-234-60EA - Each76420-234772b60b6-dc5e-429a-a3e9-b6312becfa7212022-08-04
76420-234-90EA - Each76420-23401899d9a-d7db-4e57-b53f-e05c7ab161a012022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-234GABAPENTIN CAPSULE [ASCLEMED USA, INC.]2Current NDC, Legacy NDC, 5 package rows20220710_14b1840d-a2db-4eec-bc25-029e35b042e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN14b1840d-a2db-4eec-bc25-029e35b042e42
310432gabapentin 400 MG Oral CapsulePSN14b1840d-a2db-4eec-bc25-029e35b042e42
310431gabapentin 300 MG Oral CapsuleSCD14b1840d-a2db-4eec-bc25-029e35b042e42
310432gabapentin 400 MG Oral CapsuleSCD14b1840d-a2db-4eec-bc25-029e35b042e42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-234-1276420023412120 CAPSULE in 1 BOTTLE (76420-234-12) 120 capsule2022-07-070000-00-00NoNoCurrent
76420-234-2476420023424240 CAPSULE in 1 BOTTLE (76420-234-24) 240 capsule2022-07-070000-00-00NoNoCurrent
76420-234-307642002343030 CAPSULE in 1 BOTTLE (76420-234-30) 30 capsule2022-07-070000-00-00NoNoCurrent
76420-234-607642002346060 CAPSULE in 1 BOTTLE (76420-234-60) 60 capsule2022-07-070000-00-00NoNoCurrent
76420-234-907642002349090 CAPSULE in 1 BOTTLE (76420-234-90) 90 capsule2022-07-070000-00-00NoNoCurrent