FDA.reportPublic FDA data

Gabapentin

Product NDC
71205-928
11-digit product format
712050928
Labeler code
71205
Product ID
71205-928_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
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, 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
71205-928-00Gabapentin100 in 1 BOTTLECAPSULE1004
71205-928-30Gabapentin30 in 1 BOTTLECAPSULE304
71205-928-55Gabapentin500 in 1 BOTTLECAPSULE5004
71205-928-60Gabapentin60 in 1 BOTTLECAPSULE604
71205-928-64Gabapentin240 in 1 BOTTLECAPSULE2404
71205-928-67Gabapentin270 in 1 BOTTLECAPSULE2704
71205-928-72Gabapentin120 in 1 BOTTLECAPSULE1204
71205-928-76Gabapentin360 in 1 BOTTLECAPSULE3604
71205-928-78Gabapentin180 in 1 BOTTLECAPSULE1804
71205-928-90Gabapentin90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-928-00EA - Each71205-9280c5127a5-6305-4e15-9b26-11c60186e92a12021-06-02
71205-928-30EA - Each71205-928d9fb4e00-3b62-48a5-b694-13bd078d7bbf12021-06-02
71205-928-55EA - Each71205-928f9bd7f35-54f5-4e7f-a53e-262e4f9d732612021-06-02
71205-928-60EA - Each71205-9289f525699-d2b0-4b33-a624-a8bc7bd411fe12021-06-02
71205-928-64EA - Each71205-928ba0dddb1-3b36-4253-9c37-57ec51f212f212021-06-02
71205-928-67EA - Each71205-928c6894124-f71b-49f3-9fcc-d34ebef4e38212021-07-15
71205-928-72EA - Each71205-9288a6504a0-fa91-44ee-a412-a59a4ed9509512021-06-02
71205-928-76EA - Each71205-9285d4baeab-20ed-47b5-8b05-207e20deb4a512021-07-15
71205-928-78EA - Each71205-928f6d43d44-b971-4a78-84dd-8a58102495cb12021-06-02
71205-928-90EA - Each71205-928d494461e-49f6-47b0-8774-1cac2bfb26a012021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-928GABAPENTIN 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
71205-928-0071205092800100 CAPSULE in 1 BOTTLE (71205-928-00) 100 capsule2021-04-220000-00-00NoNoCurrent
71205-928-307120509283030 CAPSULE in 1 BOTTLE (71205-928-30) 30 capsule2021-04-220000-00-00NoNoCurrent
71205-928-5571205092855500 CAPSULE in 1 BOTTLE (71205-928-55) 500 capsule2021-04-220000-00-00NoNoCurrent
71205-928-607120509286060 CAPSULE in 1 BOTTLE (71205-928-60) 60 capsule2021-04-220000-00-00NoNoCurrent
71205-928-6471205092864240 CAPSULE in 1 BOTTLE (71205-928-64) 240 capsule2021-04-220000-00-00NoNoCurrent
71205-928-6771205092867270 CAPSULE in 1 BOTTLE (71205-928-67) 270 capsule2021-06-280000-00-00NoNoCurrent
71205-928-7271205092872120 CAPSULE in 1 BOTTLE (71205-928-72) 120 capsule2021-04-220000-00-00NoNoCurrent
71205-928-7671205092876360 CAPSULE in 1 BOTTLE (71205-928-76) 360 capsule2021-06-280000-00-00NoNoCurrent
71205-928-7871205092878180 CAPSULE in 1 BOTTLE (71205-928-78) 180 capsule2021-04-220000-00-00NoNoCurrent
71205-928-907120509289090 CAPSULE in 1 BOTTLE (71205-928-90) 90 capsule2021-04-220000-00-00NoNoCurrent