FDA.reportPublic FDA data

Gabapentin

Product NDC
71205-929
11-digit product format
712050929
Labeler code
71205
Product ID
71205-929_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
300 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
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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-929-00Gabapentin100 in 1 BOTTLECAPSULE1004
71205-929-30Gabapentin30 in 1 BOTTLECAPSULE304
71205-929-55Gabapentin500 in 1 BOTTLECAPSULE5004
71205-929-60Gabapentin60 in 1 BOTTLECAPSULE604
71205-929-64Gabapentin240 in 1 BOTTLECAPSULE2404
71205-929-67Gabapentin270 in 1 BOTTLECAPSULE2704
71205-929-72Gabapentin120 in 1 BOTTLECAPSULE1204
71205-929-76Gabapentin360 in 1 BOTTLECAPSULE3604
71205-929-78Gabapentin180 in 1 BOTTLECAPSULE1804
71205-929-90Gabapentin90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-929-00EA - Each71205-92933c52bd7-4845-46f2-bfbf-65abf47466a612021-06-02
71205-929-30EA - Each71205-929dc39792f-77e4-4d8a-805b-72a917658de812021-06-02
71205-929-55EA - Each71205-929e00ee890-523d-47fe-b6ca-0f408582dd3612021-06-02
71205-929-60EA - Each71205-92957e96f27-a8fa-428b-a8d5-4536dd8b8a1412021-06-02
71205-929-64EA - Each71205-9292cec12b9-6fb9-4773-b497-66715fd8db1e12021-06-02
71205-929-67EA - Each71205-92906a07675-c0ed-4925-ab98-d40b2294d02912021-07-15
71205-929-72EA - Each71205-929ed6de88c-6a3d-4a98-91b9-7a0cd979a70912021-06-02
71205-929-76EA - Each71205-929305f5913-da92-475c-b16a-2f705c8a782b12021-07-15
71205-929-78EA - Each71205-92935725607-5ac9-455d-b639-e3f56c0e661512021-06-02
71205-929-90EA - Each71205-929f8c95867-d615-4bc6-bd04-7a7d6f29192012021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-929GABAPENTIN 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
71205-929-0071205092900100 CAPSULE in 1 BOTTLE (71205-929-00) 100 capsule2021-04-220000-00-00NoNoCurrent
71205-929-307120509293030 CAPSULE in 1 BOTTLE (71205-929-30) 30 capsule2021-04-220000-00-00NoNoCurrent
71205-929-5571205092955500 CAPSULE in 1 BOTTLE (71205-929-55) 500 capsule2021-04-220000-00-00NoNoCurrent
71205-929-607120509296060 CAPSULE in 1 BOTTLE (71205-929-60) 60 capsule2021-04-220000-00-00NoNoCurrent
71205-929-6471205092964240 CAPSULE in 1 BOTTLE (71205-929-64) 240 capsule2021-04-220000-00-00NoNoCurrent
71205-929-6771205092967270 CAPSULE in 1 BOTTLE (71205-929-67) 270 capsule2021-06-280000-00-00NoNoCurrent
71205-929-7271205092972120 CAPSULE in 1 BOTTLE (71205-929-72) 120 capsule2021-04-220000-00-00NoNoCurrent
71205-929-7671205092976360 CAPSULE in 1 BOTTLE (71205-929-76) 360 capsule2021-06-280000-00-00NoNoCurrent
71205-929-7871205092978180 CAPSULE in 1 BOTTLE (71205-929-78) 180 capsule2021-04-220000-00-00NoNoCurrent
71205-929-907120509299090 CAPSULE in 1 BOTTLE (71205-929-90) 90 capsule2021-04-220000-00-00NoNoCurrent