FDA.reportPublic FDA data

Gabapentin

Product NDC
42192-608
11-digit product format
421920608
Labeler code
42192
Product ID
42192-608_42b42328-c02f-5413-e063-6394a90ace67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin
Dosage form
SOLUTION
Route
ORAL
Labeler
Acella Pharmaceuticals, LLC
Application
ANDA076403
Marketing category
ANDA
Marketing start
2012-10-01
Substance
GABAPENTIN
Active strength
250 mg/5mL
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
GABAPENTIN250 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui283523

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
42192-608-05Gabapentin5 mL in 1 CUP, UNIT-DOSESOLUTION513
42192-608-06Gabapentin6 mL in 1 CUP, UNIT-DOSESOLUTION613
42192-608-16Gabapentin470 mL in 1 BOTTLESOLUTION47013
42192-608-40Gabapentin6 mL in 1 CUP, UNIT-DOSESOLUTION613
42192-608-40Gabapentin40 in 1 BOXSOLUTION4013
42192-608-45Gabapentin5 mL in 1 CUP, UNIT-DOSESOLUTION513
42192-608-45Gabapentin40 in 1 BOXSOLUTION4013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42192-608-05ML - Milliliter42192-608bf473aa3-aa15-4a8c-b6f6-ba3080ac465e12021-06-02
42192-608-06ML - Milliliter42192-60859c4be8d-d1a7-48d7-abe3-8ea63b64211712020-03-10
42192-608-16ML - Milliliter42192-608fb5393fc-3901-44da-933a-3777eccf4cd212013-02-13
42192-608-40ML - Milliliter42192-608f2c872c1-bdd0-4150-83ad-06ebc534b38312020-03-10
42192-608-45ML - Milliliter42192-608e0c05083-0af4-4c2f-b2eb-3a171e06071012021-06-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXGABAPENTIN SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBGABAPENTIN SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGABAPENTIN SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RGABAPENTIN SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EGABAPENTIN SOLUTION [ACELLA PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42192-608GABAPENTIN SOLUTION [ACELLA PHARMACEUTICALS, LLC]11Current NDC, Legacy NDC, 7 package rows20241011_3255245c-6ae6-46ab-a1c1-0b8d4d4cdaa2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283523gabapentin 250 MG in 5 mL Oral SolutionPSN5134369d-c7f6-4569-a425-d50e5a5d694f102
283523gabapentin 50 MG/ML Oral SolutionSCD5134369d-c7f6-4569-a425-d50e5a5d694f102
283523gabapentin 250 MG per 5 ML Oral SolutionSY5134369d-c7f6-4569-a425-d50e5a5d694f102
283523gabapentin 300 MG per 6 ML Oral SolutionSY5134369d-c7f6-4569-a425-d50e5a5d694f102
283523gabapentin 500 MG per 10 ML Oral SolutionSY5134369d-c7f6-4569-a425-d50e5a5d694f102
283523gabapentin 250 MG in 5 mL Oral SolutionPSN3255245c-6ae6-46ab-a1c1-0b8d4d4cdaa213
283523gabapentin 50 MG/ML Oral SolutionSCD3255245c-6ae6-46ab-a1c1-0b8d4d4cdaa213
283523gabapentin 250 MG per 5 ML Oral SolutionSY3255245c-6ae6-46ab-a1c1-0b8d4d4cdaa213
283523gabapentin 300 MG per 6 ML Oral SolutionSY3255245c-6ae6-46ab-a1c1-0b8d4d4cdaa213
283523gabapentin 500 MG per 10 ML Oral SolutionSY3255245c-6ae6-46ab-a1c1-0b8d4d4cdaa213
283523gabapentin 250 MG in 5 mL Oral SolutionPSN5969f1a8-d6d5-4967-add5-4e2492354d7b7
283523gabapentin 50 MG/ML Oral SolutionSCD5969f1a8-d6d5-4967-add5-4e2492354d7b7
283523gabapentin 250 MG per 5 ML Oral SolutionSY5969f1a8-d6d5-4967-add5-4e2492354d7b7
283523gabapentin 300 MG per 6 ML Oral SolutionSY5969f1a8-d6d5-4967-add5-4e2492354d7b7
283523gabapentin 500 MG per 10 ML Oral SolutionSY5969f1a8-d6d5-4967-add5-4e2492354d7b7
283523gabapentin 250 MG in 5 mL Oral SolutionPSN2b4d316c-1234-41d7-831d-645b3dd6e4482
283523gabapentin 50 MG/ML Oral SolutionSCD2b4d316c-1234-41d7-831d-645b3dd6e4482
283523gabapentin 250 MG per 5 ML Oral SolutionSY2b4d316c-1234-41d7-831d-645b3dd6e4482
283523gabapentin 300 MG per 6 ML Oral SolutionSY2b4d316c-1234-41d7-831d-645b3dd6e4482
283523gabapentin 500 MG per 10 ML Oral SolutionSY2b4d316c-1234-41d7-831d-645b3dd6e4482

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42192-608-05421920608055 mL in 1 CUP, UNIT-DOSE (42192-608-05) 5 ml2019-08-160000-00-00NoNoCurrent
42192-608-06421920608066 mL in 1 CUP, UNIT-DOSE (42192-608-06) 6 ml2019-08-160000-00-00NoNoCurrent
42192-608-1642192060816470 mL in 1 BOTTLE (42192-608-16) 470 ml2012-10-010000-00-00NoNoCurrent
42192-608-404219206084040 CUP, UNIT-DOSE in 1 BOX (42192-608-40) / 6 mL in 1 CUP, UNIT-DOSE2019-08-160000-00-00NoNoCurrent
42192-608-454219206084540 CUP, UNIT-DOSE in 1 BOX (42192-608-45) / 5 mL in 1 CUP, UNIT-DOSE2021-05-050000-00-00NoNoCurrent