FDA.reportPublic FDA data

Gabapentin

Product NDC
71205-930
11-digit product format
712050930
Labeler code
71205
Product ID
71205-930_dc28cbd4-d236-4c09-93e9-a6088c0d2b4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA204989
Marketing category
ANDA
Marketing start
2016-04-01
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
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
71205-930-00Gabapentin100 in 1 BOTTLECAPSULE1004
71205-930-30Gabapentin30 in 1 BOTTLECAPSULE304
71205-930-55Gabapentin500 in 1 BOTTLECAPSULE5004
71205-930-60Gabapentin60 in 1 BOTTLECAPSULE604
71205-930-64Gabapentin240 in 1 BOTTLECAPSULE2404
71205-930-67Gabapentin270 in 1 BOTTLECAPSULE2704
71205-930-72Gabapentin120 in 1 BOTTLECAPSULE1204
71205-930-76Gabapentin360 in 1 BOTTLECAPSULE3604
71205-930-78Gabapentin180 in 1 BOTTLECAPSULE1804
71205-930-90Gabapentin90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-930-00EA - Each71205-93082a6a66a-82b4-4a5e-bfee-e48277fc194712021-06-02
71205-930-30EA - Each71205-9300636a078-59ea-47c1-a57d-cac50c3bbdf712021-06-02
71205-930-55EA - Each71205-93014078dcc-9cc6-4301-b36d-b72df1a8bddc12021-06-02
71205-930-60EA - Each71205-930a5d4d402-165c-4844-b257-17fa59541fe212021-06-02
71205-930-64EA - Each71205-93007a00277-d537-436a-8963-6d88814c083512021-06-02
71205-930-67EA - Each71205-930604ba03b-9459-4bd1-b7de-56b14183347f12021-07-15
71205-930-72EA - Each71205-93005e20f9d-47d4-4518-8e5f-7b700050b57312021-06-02
71205-930-76EA - Each71205-9302871755e-cf40-4d38-9d29-b4566491669b12021-07-15
71205-930-78EA - Each71205-930c988909c-5ad6-4b64-94c2-5327b4cb432812021-06-02
71205-930-90EA - Each71205-93094c24c5e-2ebe-4147-ac8d-190f3da40d3612021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-930GABAPENTIN CAPSULE [PROFICIENT RX LP]4Current NDC, Legacy NDC, 10 package rows20220421_52af51ab-6543-466b-848c-13c588c98789.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN52af51ab-6543-466b-848c-13c588c987894
310431gabapentin 300 MG Oral CapsulePSN52af51ab-6543-466b-848c-13c588c987894
310432gabapentin 400 MG Oral CapsulePSN52af51ab-6543-466b-848c-13c588c987894
310430gabapentin 100 MG Oral CapsuleSCD52af51ab-6543-466b-848c-13c588c987894
310431gabapentin 300 MG Oral CapsuleSCD52af51ab-6543-466b-848c-13c588c987894
310432gabapentin 400 MG Oral CapsuleSCD52af51ab-6543-466b-848c-13c588c987894

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-930-0071205093000100 CAPSULE in 1 BOTTLE (71205-930-00) 100 capsule2021-04-220000-00-00NoNoCurrent
71205-930-307120509303030 CAPSULE in 1 BOTTLE (71205-930-30) 30 capsule2021-04-220000-00-00NoNoCurrent
71205-930-5571205093055500 CAPSULE in 1 BOTTLE (71205-930-55) 500 capsule2021-04-220000-00-00NoNoCurrent
71205-930-607120509306060 CAPSULE in 1 BOTTLE (71205-930-60) 60 capsule2021-04-220000-00-00NoNoCurrent
71205-930-6471205093064240 CAPSULE in 1 BOTTLE (71205-930-64) 240 capsule2021-04-220000-00-00NoNoCurrent
71205-930-6771205093067270 CAPSULE in 1 BOTTLE (71205-930-67) 270 capsule2021-06-280000-00-00NoNoCurrent
71205-930-7271205093072120 CAPSULE in 1 BOTTLE (71205-930-72) 120 capsule2021-04-220000-00-00NoNoCurrent
71205-930-7671205093076360 CAPSULE in 1 BOTTLE (71205-930-76) 360 capsule2021-06-280000-00-00NoNoCurrent
71205-930-7871205093078180 CAPSULE in 1 BOTTLE (71205-930-78) 180 capsule2021-04-220000-00-00NoNoCurrent
71205-930-907120509309090 CAPSULE in 1 BOTTLE (71205-930-90) 90 capsule2021-04-220000-00-00NoNoCurrent