Gabapentin

Product NDC
71093-121
11-digit product format
710930121
Labeler code
71093
Product ID
71093-121_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
300 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
GABAPENTIN300 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
71093-121-04Gabapentin100 in 1 BOTTLE, PLASTICCAPSULE1009
71093-121-05Gabapentin500 in 1 BOTTLE, PLASTICCAPSULE5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71093-121-04EA - Each71093-12103ceaf72-5ea0-4947-afe8-f8ddeac27fd012018-08-13
71093-121-05EA - Each71093-1216cbe8b9b-8b03-4776-bd0e-482458fc0b3b12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71093-121GABAPENTIN 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
310431gabapentin 300 MG Oral CapsulePSNfb0b6613-57d6-4e24-946f-f5f87c460cf0104
310431gabapentin 300 MG Oral CapsuleSCDfb0b6613-57d6-4e24-946f-f5f87c460cf0104
310431gabapentin 300 MG Oral CapsulePSN9efd0261-9fc9-4dc9-8cf3-9110157ddfc4101
310431gabapentin 300 MG Oral CapsuleSCD9efd0261-9fc9-4dc9-8cf3-9110157ddfc4101
310431gabapentin 300 MG Oral CapsulePSN01b810b7-f4c8-4412-bbc5-b9220d8770d811
310431gabapentin 300 MG Oral CapsuleSCD01b810b7-f4c8-4412-bbc5-b9220d8770d811
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
310431gabapentin 300 MG Oral CapsulePSNaf73fbd8-9731-e6bf-e053-2995a90af65d5
310431gabapentin 300 MG Oral CapsuleSCDaf73fbd8-9731-e6bf-e053-2995a90af65d5
310431gabapentin 300 MG Oral CapsulePSN1ec656c9-034f-4f14-9e6b-9779d41e16274
310431gabapentin 300 MG Oral CapsuleSCD1ec656c9-034f-4f14-9e6b-9779d41e16274
310431gabapentin 300 MG Oral CapsulePSNde990f96-96bc-406d-e053-2995a90abebb3
310431gabapentin 300 MG Oral CapsulePSNed219efc-84e3-5bdc-e053-2a95a90a56fc3
310431gabapentin 300 MG Oral CapsuleSCDde990f96-96bc-406d-e053-2995a90abebb3
310431gabapentin 300 MG Oral CapsuleSCDed219efc-84e3-5bdc-e053-2a95a90a56fc3
310431gabapentin 300 MG Oral CapsulePSNedc2cf85-4f80-65d2-e053-2995a90aed3c2
310431gabapentin 300 MG Oral CapsulePSN167d8b87-506c-4293-9579-563feaa715832
310431gabapentin 300 MG Oral CapsuleSCDedc2cf85-4f80-65d2-e053-2995a90aed3c2
310431gabapentin 300 MG Oral CapsuleSCD167d8b87-506c-4293-9579-563feaa715832

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71093-121-0471093012104100 CAPSULE in 1 BOTTLE, PLASTIC (71093-121-04) 100 capsule2018-08-040000-00-00NoNoCurrent
71093-121-0571093012105500 CAPSULE in 1 BOTTLE, PLASTIC (71093-121-05) 500 capsule2018-08-040000-00-00NoNoCurrent