FDA.reportPublic FDA data

Gabapentin

Product NDC
55700-950
11-digit product format
557000950
Labeler code
55700
Product ID
55700-950_a1d85d35-87be-497d-acf2-5f9ef9267328
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA204989
Marketing category
ANDA
Marketing start
2021-12-16
Marketing end
2027-02-28
Substance
GABAPENTIN
Active strength
100 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gabapentin

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310430, 310431

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
55700-950-01Gabapentin120 in 1 BOTTLE, PLASTICCAPSULE1206
55700-950-30Gabapentin30 in 1 BOTTLE, PLASTICCAPSULE306
55700-950-60Gabapentin60 in 1 BOTTLE, PLASTICCAPSULE606
55700-950-90Gabapentin90 in 1 BOTTLE, PLASTICCAPSULE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-950-01EA - Each55700-950639dcc37-dc74-4501-bc37-5a1bed7facc612022-03-09
55700-950-30EA - Each55700-9503656f8dd-d710-4623-849b-08e07481e17012022-03-09
55700-950-60EA - Each55700-9500bd1617f-0cf0-4efe-95bb-c5c86b71569112022-03-09
55700-950-90EA - Each55700-950f8c4f0a3-7fc8-450d-944f-149a0237992412022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-950GABAPENTIN CAPSULE [QUALITY CARE PRODUCTS, LLC]6Current NDC, Legacy NDC, 4 package rows20241220_ed3a0d48-2e98-44ee-8743-880d1221a480.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNed3a0d48-2e98-44ee-8743-880d1221a4806
310431gabapentin 300 MG Oral CapsulePSNed3a0d48-2e98-44ee-8743-880d1221a4806
310430gabapentin 100 MG Oral CapsuleSCDed3a0d48-2e98-44ee-8743-880d1221a4806
310431gabapentin 300 MG Oral CapsuleSCDed3a0d48-2e98-44ee-8743-880d1221a4806

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-950-0155700095001120 CAPSULE in 1 BOTTLE, PLASTIC (55700-950-01) 120 capsule2022-01-040000-00-00NoNoCurrent
55700-950-305570009503030 CAPSULE in 1 BOTTLE, PLASTIC (55700-950-30) 30 capsule2021-12-162027-02-28NoNoCurrent
55700-950-605570009506060 CAPSULE in 1 BOTTLE, PLASTIC (55700-950-60) 60 capsule2021-12-162027-02-28NoNoCurrent
55700-950-905570009509090 CAPSULE in 1 BOTTLE, PLASTIC (55700-950-90) 90 capsule2021-12-170000-00-00NoNoCurrent