FDA.reportPublic FDA data

gabapentin

Product NDC
16571-869
11-digit product format
165710869
Labeler code
16571
Product ID
16571-869_2e493243-47c0-460e-bea9-4ed0261adf90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA207099
Marketing category
ANDA
Marketing start
2022-08-01
Substance
GABAPENTIN
Active strength
400 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
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16571-869-01gabapentin100 in 1 BOTTLECAPSULE1003
16571-869-03gabapentin30 in 1 BOTTLECAPSULE303
16571-869-10gabapentin1000 in 1 BOTTLECAPSULE10003
16571-869-50gabapentin500 in 1 BOTTLECAPSULE5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-869-01EA - Each16571-86912700b92-ac44-40e4-b32d-cca9c6f3cf7d12022-08-04
16571-869-10EA - Each16571-869800be359-c1b9-4476-8918-bf3565c9e2a012022-08-04
16571-869-50EA - Each16571-869c7a285ea-c218-4b78-a8bc-b4d79f6df59912022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-869GABAPENTIN CAPSULE [RISING PHARMA HOLDINGS, INC.]2Current NDC, Legacy NDC, 4 package rows20250529_969cccfc-e56a-49da-9d36-47c0c3fad7f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310432gabapentin 400 MG Oral CapsulePSN0b286fd1-8179-d87a-e063-6294a90a2f234
310432gabapentin 400 MG Oral CapsuleSCD0b286fd1-8179-d87a-e063-6294a90a2f234
310430gabapentin 100 MG Oral CapsulePSN969cccfc-e56a-49da-9d36-47c0c3fad7f83
310431gabapentin 300 MG Oral CapsulePSN969cccfc-e56a-49da-9d36-47c0c3fad7f83
310432gabapentin 400 MG Oral CapsulePSN969cccfc-e56a-49da-9d36-47c0c3fad7f83
310430gabapentin 100 MG Oral CapsuleSCD969cccfc-e56a-49da-9d36-47c0c3fad7f83
310431gabapentin 300 MG Oral CapsuleSCD969cccfc-e56a-49da-9d36-47c0c3fad7f83
310432gabapentin 400 MG Oral CapsuleSCD969cccfc-e56a-49da-9d36-47c0c3fad7f83
310432gabapentin 400 MG Oral CapsulePSN35d3ed6b-7867-fccc-e063-6294a90a67061
310432gabapentin 400 MG Oral CapsulePSN3eeda97d-c3cd-65cd-e063-6394a90aae8b1
310432gabapentin 400 MG Oral CapsulePSN4a975ebe-ae0a-446a-8a3d-2ca325e28f931
310432gabapentin 400 MG Oral CapsuleSCD35d3ed6b-7867-fccc-e063-6294a90a67061
310432gabapentin 400 MG Oral CapsuleSCD3eeda97d-c3cd-65cd-e063-6394a90aae8b1
310432gabapentin 400 MG Oral CapsuleSCD4a975ebe-ae0a-446a-8a3d-2ca325e28f931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-869-0116571086901100 CAPSULE in 1 BOTTLE (16571-869-01) 100 capsule2022-08-010000-00-00NoNoCurrent
16571-869-031657108690330 CAPSULE in 1 BOTTLE (16571-869-03) 30 capsule2022-08-010000-00-00NoNoCurrent
16571-869-10165710869101000 CAPSULE in 1 BOTTLE (16571-869-10) 1000 capsule2022-08-010000-00-00NoNoCurrent
16571-869-5016571086950500 CAPSULE in 1 BOTTLE (16571-869-50) 500 capsule2022-08-010000-00-00NoNoCurrent