gabapentin

Product NDC
16571-867
11-digit product format
165710867
Labeler code
16571
Product ID
16571-867_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
100 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
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
16571-867-01gabapentin100 in 1 BOTTLECAPSULE1003
16571-867-03gabapentin30 in 1 BOTTLECAPSULE303
16571-867-10gabapentin1000 in 1 BOTTLECAPSULE10003
16571-867-50gabapentin500 in 1 BOTTLECAPSULE5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-867-01EA - Each16571-867ab195397-1fd7-4ea2-81d0-d3d9ab1667e512022-08-04
16571-867-10EA - Each16571-8670fae73fd-278c-41a1-b236-a791899a7e5712022-08-04
16571-867-50EA - Each16571-8670e680126-9cf9-4415-93a4-41c9a62de53112022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-867GABAPENTIN 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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-867-0116571086701100 CAPSULE in 1 BOTTLE (16571-867-01) 100 capsule2022-08-010000-00-00NoNoCurrent
16571-867-031657108670330 CAPSULE in 1 BOTTLE (16571-867-03) 30 capsule2022-08-010000-00-00NoNoCurrent
16571-867-10165710867101000 CAPSULE in 1 BOTTLE (16571-867-10) 1000 capsule2022-08-010000-00-00NoNoCurrent
16571-867-5016571086750500 CAPSULE in 1 BOTTLE (16571-867-50) 500 capsule2022-08-010000-00-00NoNoCurrent