FDA.reportPublic FDA data

gabapentin

Product NDC
16571-868
11-digit product format
165710868
Labeler code
16571
Product ID
16571-868_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
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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16571-868-01gabapentin100 in 1 BOTTLECAPSULE1003
16571-868-03gabapentin30 in 1 BOTTLECAPSULE303
16571-868-10gabapentin1000 in 1 BOTTLECAPSULE10003
16571-868-50gabapentin500 in 1 BOTTLECAPSULE5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-868-01EA - Each16571-868556b71b2-bdb3-45aa-9562-ed7d6de2a31512022-08-04
16571-868-10EA - Each16571-868e36200fe-2856-49c8-a813-d5624f79ac5b12022-08-04
16571-868-50EA - Each16571-8684b586652-6755-44e2-93b8-d520fed89c8f12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-868GABAPENTIN 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
310431gabapentin 300 MG Oral CapsulePSN2bc65375-77b8-1e50-e063-6294a90acf8f4
310431gabapentin 300 MG Oral CapsulePSN2cb1ad6d-d389-4564-e063-6394a90a36444
310431gabapentin 300 MG Oral CapsuleSCD2bc65375-77b8-1e50-e063-6294a90acf8f4
310431gabapentin 300 MG Oral CapsuleSCD2cb1ad6d-d389-4564-e063-6394a90a36444
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
310431gabapentin 300 MG Oral CapsulePSN471b2d32-0cbd-aade-e063-6394a90a16962
310431gabapentin 300 MG Oral CapsuleSCD471b2d32-0cbd-aade-e063-6394a90a16962
310431gabapentin 300 MG Oral CapsulePSN64a65366-8577-48f2-9f8e-0332f126d3c11
310431gabapentin 300 MG Oral CapsuleSCD64a65366-8577-48f2-9f8e-0332f126d3c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-868-0116571086801100 CAPSULE in 1 BOTTLE (16571-868-01) 100 capsule2022-08-010000-00-00NoNoCurrent
16571-868-031657108680330 CAPSULE in 1 BOTTLE (16571-868-03) 30 capsule2022-08-010000-00-00NoNoCurrent
16571-868-10165710868101000 CAPSULE in 1 BOTTLE (16571-868-10) 1000 capsule2022-08-010000-00-00NoNoCurrent
16571-868-5016571086850500 CAPSULE in 1 BOTTLE (16571-868-50) 500 capsule2022-08-010000-00-00NoNoCurrent