FDA.reportPublic FDA data

GABAPENTIN

Product NDC
72865-254
11-digit product format
728650254
Labeler code
72865
Product ID
72865-254_702f8307-681f-440d-9f1d-3d26141a914b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
XLCare Pharmaceuticals, Inc.
Application
ANDA214956
Marketing category
ANDA
Marketing start
2021-05-10
Substance
GABAPENTIN
Active strength
400 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
GABAPENTIN400 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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72865-254-05GABAPENTIN500 in 1 BOTTLECAPSULE5003
72865-254-27GABAPENTIN270 in 1 BOTTLECAPSULE2703
72865-254-90GABAPENTIN90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72865-254-05EA - Each72865-254ff9593e7-3727-4b8c-ab74-259e111815b312023-12-05
72865-254-27EA - Each72865-2545066c217-8da4-4c0c-80f2-b653fdb3c7d112023-12-05
72865-254-90EA - Each72865-2546f826348-679d-4381-a93d-0363eaf65d5012023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72865-254GABAPENTIN CAPSULE [XLCARE PHARMACEUTICALS, INC.]1Current NDC, 3 package rows20231122_618c948d-deee-44e2-98f0-e5232171dd50.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNf38098ec-dd1a-405a-bbfb-bad62e4e7fa56
310431gabapentin 300 MG Oral CapsulePSNf38098ec-dd1a-405a-bbfb-bad62e4e7fa56
310432gabapentin 400 MG Oral CapsulePSNf38098ec-dd1a-405a-bbfb-bad62e4e7fa56
310430gabapentin 100 MG Oral CapsuleSCDf38098ec-dd1a-405a-bbfb-bad62e4e7fa56
310431gabapentin 300 MG Oral CapsuleSCDf38098ec-dd1a-405a-bbfb-bad62e4e7fa56
310432gabapentin 400 MG Oral CapsuleSCDf38098ec-dd1a-405a-bbfb-bad62e4e7fa56
310430gabapentin 100 MG Oral CapsulePSN618c948d-deee-44e2-98f0-e5232171dd503
310431gabapentin 300 MG Oral CapsulePSN618c948d-deee-44e2-98f0-e5232171dd503
310432gabapentin 400 MG Oral CapsulePSN618c948d-deee-44e2-98f0-e5232171dd503
310430gabapentin 100 MG Oral CapsuleSCD618c948d-deee-44e2-98f0-e5232171dd503
310431gabapentin 300 MG Oral CapsuleSCD618c948d-deee-44e2-98f0-e5232171dd503
310432gabapentin 400 MG Oral CapsuleSCD618c948d-deee-44e2-98f0-e5232171dd503

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72865-254-0572865025405500 CAPSULE in 1 BOTTLE (72865-254-05) 500 capsule2021-05-10NoNoCurrent
72865-254-2772865025427270 CAPSULE in 1 BOTTLE (72865-254-27) 270 capsule2021-05-10NoNoCurrent
72865-254-907286502549090 CAPSULE in 1 BOTTLE (72865-254-90) 90 capsule2021-05-10NoNoCurrent