FDA.reportPublic FDA data

Gabapentin

Product NDC
71093-120
11-digit product format
710930120
Labeler code
71093
Product ID
71093-120_a916797c-381c-4008-b778-19221233ef45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
ACI Healthcare USA, Inc.
Application
ANDA206943
Marketing category
ANDA
Marketing start
2018-05-14
Substance
GABAPENTIN
Active strength
100 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
GABAPENTIN100 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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71093-120-04Gabapentin100 in 1 BOTTLE, PLASTICCAPSULE1009
71093-120-05Gabapentin500 in 1 BOTTLE, PLASTICCAPSULE5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71093-120-04EA - Each71093-120b83f17a6-061f-4e29-894d-5ef0c32c9e3b12018-08-13
71093-120-05EA - Each71093-120b8ac95ca-3609-4d9e-aa5e-fa02e0def34912018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71093-120GABAPENTIN CAPSULE [ACI HEALTHCARE USA, INC.]9Current NDC, Legacy NDC, 2 package rows20231218_7538e255-95df-4991-aae0-a90d709f1e95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN8de89818-805a-4a20-a9b1-48cf443b6315104
310430gabapentin 100 MG Oral CapsuleSCD8de89818-805a-4a20-a9b1-48cf443b6315104
310430gabapentin 100 MG Oral CapsulePSN38210141-bbdc-4186-b71f-54c72f794dca102
310430gabapentin 100 MG Oral CapsulePSNef37f2a0-3b83-4f71-91c0-6435161b483c102
310430gabapentin 100 MG Oral CapsuleSCDef37f2a0-3b83-4f71-91c0-6435161b483c102
310430gabapentin 100 MG Oral CapsuleSCD38210141-bbdc-4186-b71f-54c72f794dca102
310430gabapentin 100 MG Oral CapsulePSN75418d32-6504-4cb4-b3a9-afa0eaf19b8d101
310430gabapentin 100 MG Oral CapsuleSCD75418d32-6504-4cb4-b3a9-afa0eaf19b8d101
310430gabapentin 100 MG Oral CapsulePSNca8177ed-1f0d-436e-a5ac-f58b8f7cbb25100
310430gabapentin 100 MG Oral CapsuleSCDca8177ed-1f0d-436e-a5ac-f58b8f7cbb25100
310430gabapentin 100 MG Oral CapsulePSN7538e255-95df-4991-aae0-a90d709f1e959
310431gabapentin 300 MG Oral CapsulePSN7538e255-95df-4991-aae0-a90d709f1e959
310432gabapentin 400 MG Oral CapsulePSN7538e255-95df-4991-aae0-a90d709f1e959
310430gabapentin 100 MG Oral CapsuleSCD7538e255-95df-4991-aae0-a90d709f1e959
310431gabapentin 300 MG Oral CapsuleSCD7538e255-95df-4991-aae0-a90d709f1e959
310432gabapentin 400 MG Oral CapsuleSCD7538e255-95df-4991-aae0-a90d709f1e959
310430gabapentin 100 MG Oral CapsulePSN96cb7daa-a57a-6b0b-e053-2995a90add237
310430gabapentin 100 MG Oral CapsuleSCD96cb7daa-a57a-6b0b-e053-2995a90add237
310430gabapentin 100 MG Oral CapsulePSNf40a4ee4-ae8e-769c-e053-2a95a90a344e6
310430gabapentin 100 MG Oral CapsulePSN8e6ed5d2-40e0-1f06-e053-2a95a90aa40e6
310430gabapentin 100 MG Oral CapsuleSCD8e6ed5d2-40e0-1f06-e053-2a95a90aa40e6
310430gabapentin 100 MG Oral CapsuleSCDf40a4ee4-ae8e-769c-e053-2a95a90a344e6
310430gabapentin 100 MG Oral CapsulePSN6ecf5114-2ddc-4025-a36d-1884702dc22a5
310430gabapentin 100 MG Oral CapsulePSNf396ec70-826d-45c6-a27c-343c2fac878c5
310430gabapentin 100 MG Oral CapsuleSCD6ecf5114-2ddc-4025-a36d-1884702dc22a5
310430gabapentin 100 MG Oral CapsuleSCDf396ec70-826d-45c6-a27c-343c2fac878c5
310430gabapentin 100 MG Oral CapsulePSN645824d0-eb3d-442b-806d-36a70796cb8e4
310430gabapentin 100 MG Oral CapsuleSCD645824d0-eb3d-442b-806d-36a70796cb8e4
310430gabapentin 100 MG Oral CapsulePSNe7ae4911-58b6-4249-8d74-85a6decb68f33
310430gabapentin 100 MG Oral CapsuleSCDe7ae4911-58b6-4249-8d74-85a6decb68f33
310430gabapentin 100 MG Oral CapsulePSNf93eaa4f-cc1a-10ab-e053-6394a90a5ffc2
310430gabapentin 100 MG Oral CapsuleSCDf93eaa4f-cc1a-10ab-e053-6394a90a5ffc2
310430gabapentin 100 MG Oral CapsulePSN1278512b-1493-db65-e063-6394a90ab1611
310430gabapentin 100 MG Oral CapsuleSCD1278512b-1493-db65-e063-6394a90ab1611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71093-120-0471093012004100 CAPSULE in 1 BOTTLE, PLASTIC (71093-120-04) 100 capsule2018-08-040000-00-00NoNoCurrent
71093-120-0571093012005500 CAPSULE in 1 BOTTLE, PLASTIC (71093-120-05) 500 capsule2018-08-040000-00-00NoNoCurrent