FDA.reportPublic FDA data

GABAPENTIN

Product NDC
71205-661
11-digit product format
712050661
Labeler code
71205
Product ID
71205-661_aa3ab216-372a-4a72-bfd1-88a1ffa31ba3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA075360
Marketing category
ANDA
Marketing start
2020-09-07
Substance
GABAPENTIN
Active strength
100 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
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
71205-661-15GABAPENTIN15 in 1 BOTTLECAPSULE151
71205-661-30GABAPENTIN30 in 1 BOTTLECAPSULE301
71205-661-60GABAPENTIN60 in 1 BOTTLECAPSULE601
71205-661-90GABAPENTIN90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-661-15EA - Each71205-6618c3bf4f8-cad7-4d9c-9f9e-4ea214a7f63412022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-661GABAPENTIN CAPSULE [PROFICIENT RX LP]1Current NDC, Legacy NDC, 4 package rows20220521_aa3ab216-372a-4a72-bfd1-88a1ffa31ba3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNaa3ab216-372a-4a72-bfd1-88a1ffa31ba31
310430gabapentin 100 MG Oral CapsuleSCDaa3ab216-372a-4a72-bfd1-88a1ffa31ba31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-661-157120506611515 CAPSULE in 1 BOTTLE (71205-661-15) 15 capsule2022-05-170000-00-00NoNoCurrent
71205-661-307120506613030 CAPSULE in 1 BOTTLE (71205-661-30) 30 capsule2022-05-170000-00-00NoNoCurrent
71205-661-607120506616060 CAPSULE in 1 BOTTLE (71205-661-60) 60 capsule2022-05-170000-00-00NoNoCurrent
71205-661-907120506619090 CAPSULE in 1 BOTTLE (71205-661-90) 90 capsule2022-05-170000-00-00NoNoCurrent