FDA.reportPublic FDA data

Gabapentin

Product NDC
55700-949
11-digit product format
557000949
Labeler code
55700
Product ID
55700-949_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
2021-12-07
Marketing end
2027-05-31
Substance
GABAPENTIN
Active strength
300 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
GABAPENTIN300 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
55700-949-01Gabapentin120 in 1 BOTTLE, PLASTICCAPSULE1206
55700-949-30Gabapentin30 in 1 BOTTLE, PLASTICCAPSULE306
55700-949-60Gabapentin60 in 1 BOTTLE, PLASTICCAPSULE606
55700-949-90Gabapentin90 in 1 BOTTLE, PLASTICCAPSULE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-949-01EA - Each55700-9497ad4d503-33a6-45f4-a75d-e13fd502431912022-03-09
55700-949-30EA - Each55700-949212d382b-ce48-4ad1-99b1-118ca7410d3112022-03-09
55700-949-60EA - Each55700-949f8eb0dbe-b752-4e66-b9dc-6b9a98b6818112022-03-09
55700-949-90EA - Each55700-949ab5be65a-bbf5-4704-bef8-59e80ea1232b12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-949GABAPENTIN 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
55700-949-0155700094901120 CAPSULE in 1 BOTTLE, PLASTIC (55700-949-01) 120 capsule2021-12-072027-05-31NoNoCurrent
55700-949-305570009493030 CAPSULE in 1 BOTTLE, PLASTIC (55700-949-30) 30 capsule2021-12-070000-00-00NoNoCurrent
55700-949-605570009496060 CAPSULE in 1 BOTTLE, PLASTIC (55700-949-60) 60 capsule2021-12-072027-05-31NoNoCurrent
55700-949-905570009499090 CAPSULE in 1 BOTTLE, PLASTIC (55700-949-90) 90 capsule2021-12-072027-05-31NoNoCurrent