FDA.reportPublic FDA data

Gralise

Product NDC
52427-803
11-digit product format
524270803
Labeler code
52427
Product ID
52427-803_44a61305-2313-59c4-8a44-98c827461735
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Almatica Pharma LLC
Application
NDA022544
Marketing category
NDA
Marketing start
2020-10-01
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
Gralise
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui1115012, 1115013, 1806380, 1806382, 2398511, 2398512, 2634743, 2634745, 2634747, 2634749, 2634751, 2634753

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52427-803-902024-01-30C16284748780-11030e365-1ded-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GRALISE safely and effectively. See full prescribing information for GRALISE. GRALISE ® (gabapentin) tablets, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52427-803-90Gralise90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52427-803GRALISE (GABAPENTIN) TABLET, FILM COATED GRALISE (GABAPENTIN) KIT [ALMATICA PHARMA LLC]5Current NDC, Legacy NDC, 1 package rows20240704_466273b1-c9fc-3930-c94b-aa11394d5140.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2398512{9 (Once-Daily gabapentin 300 MG Oral Tablet [Gralise]) / 24 (Once-Daily gabapentin 600 MG Oral Tablet [Gralise]) } Pack [Gralise Sample Pack]BPCK466273b1-c9fc-3930-c94b-aa11394d51406
2398511{9 (Once-Daily gabapentin 300 MG Oral Tablet) / 24 (Once-Daily gabapentin 600 MG Oral Tablet) } PackGPCK466273b1-c9fc-3930-c94b-aa11394d51406
1806380gabapentin 300 MG Once-Daily Oral TabletPSN466273b1-c9fc-3930-c94b-aa11394d51406
2634747gabapentin 450 MG Once-Daily Oral TabletPSN466273b1-c9fc-3930-c94b-aa11394d51406
1806382gabapentin 600 MG Once-Daily Oral TabletPSN466273b1-c9fc-3930-c94b-aa11394d51406
2634751gabapentin 750 MG Once-Daily Oral TabletPSN466273b1-c9fc-3930-c94b-aa11394d51406
2634743gabapentin 900 MG Once-Daily Oral TabletPSN466273b1-c9fc-3930-c94b-aa11394d51406
2398511gabapentin sample pack 300 MG (9), 600 MG (24) Once-Daily Oral TabletPSN466273b1-c9fc-3930-c94b-aa11394d51406
1115012Gralise 300 MG Once-Daily Oral TabletPSN466273b1-c9fc-3930-c94b-aa11394d51406
2634749Gralise 450 MG Once-Daily Oral TabletPSN466273b1-c9fc-3930-c94b-aa11394d51406
1115013Gralise 600 MG Once-Daily Oral TabletPSN466273b1-c9fc-3930-c94b-aa11394d51406
2634753Gralise 750 MG Once-Daily Oral TabletPSN466273b1-c9fc-3930-c94b-aa11394d51406
2634745Gralise 900 MG Once-Daily Oral TabletPSN466273b1-c9fc-3930-c94b-aa11394d51406
2398512Gralise Sample PackPSN466273b1-c9fc-3930-c94b-aa11394d51406
1115012Once-Daily gabapentin 300 MG Oral Tablet [Gralise]SBD466273b1-c9fc-3930-c94b-aa11394d51406
2634749Once-Daily gabapentin 450 MG Oral Tablet [Gralise]SBD466273b1-c9fc-3930-c94b-aa11394d51406
1115013Once-Daily gabapentin 600 MG Oral Tablet [Gralise]SBD466273b1-c9fc-3930-c94b-aa11394d51406
2634753Once-Daily gabapentin 750 MG Oral Tablet [Gralise]SBD466273b1-c9fc-3930-c94b-aa11394d51406
2634745Once-Daily gabapentin 900 MG Oral Tablet [Gralise]SBD466273b1-c9fc-3930-c94b-aa11394d51406
1806380Once-Daily gabapentin 300 MG Oral TabletSCD466273b1-c9fc-3930-c94b-aa11394d51406
2634747Once-Daily gabapentin 450 MG Oral TabletSCD466273b1-c9fc-3930-c94b-aa11394d51406
1806382Once-Daily gabapentin 600 MG Oral TabletSCD466273b1-c9fc-3930-c94b-aa11394d51406
2634751Once-Daily gabapentin 750 MG Oral TabletSCD466273b1-c9fc-3930-c94b-aa11394d51406
2634743Once-Daily gabapentin 900 MG Oral TabletSCD466273b1-c9fc-3930-c94b-aa11394d51406
1806380gabapentin 300 MG Once-Daily Oral TabletSY466273b1-c9fc-3930-c94b-aa11394d51406
2634747gabapentin 450 MG Once-Daily Oral TabletSY466273b1-c9fc-3930-c94b-aa11394d51406
1806382gabapentin 600 MG Once-Daily Oral TabletSY466273b1-c9fc-3930-c94b-aa11394d51406
2634751gabapentin 750 MG Once-Daily Oral TabletSY466273b1-c9fc-3930-c94b-aa11394d51406
2634743gabapentin 900 MG Once-Daily Oral TabletSY466273b1-c9fc-3930-c94b-aa11394d51406
2398511gabapentin sample pack {9 (gabapentin 300 MG Once-Daily Oral Tablet) / 24 (gabapentin 600 MG Once-Daily Oral Tablet) }SY466273b1-c9fc-3930-c94b-aa11394d51406
2398512Gralise 15-Day Sample PackSY466273b1-c9fc-3930-c94b-aa11394d51406
1115012Gralise 300 MG Once-Daily Oral TabletSY466273b1-c9fc-3930-c94b-aa11394d51406
2634749Gralise 450 MG Oral Tablet, Once DailySY466273b1-c9fc-3930-c94b-aa11394d51406
1115013Gralise 600 MG Once-Daily Oral TabletSY466273b1-c9fc-3930-c94b-aa11394d51406
2634753Gralise 750 MG Once-Daily Oral TabletSY466273b1-c9fc-3930-c94b-aa11394d51406
2634745Gralise 900 MG Once-Daily Oral TabletSY466273b1-c9fc-3930-c94b-aa11394d51406
1115012Once-Daily Gralise 300 MG Oral TabletSY466273b1-c9fc-3930-c94b-aa11394d51406
2634749Once-Daily Gralise 450 MG Oral TabletSY466273b1-c9fc-3930-c94b-aa11394d51406
1115013Once-Daily Gralise 600 MG Oral TabletSY466273b1-c9fc-3930-c94b-aa11394d51406
2634753Once-Daily Gralise 750 MG Oral TabletSY466273b1-c9fc-3930-c94b-aa11394d51406
2634745Once-Daily Gralise 900 MG Oral TabletSY466273b1-c9fc-3930-c94b-aa11394d51406

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52427-803-905242708039090 TABLET, FILM COATED in 1 BOTTLE (52427-803-90) 2020-10-010000-00-00NoNoCurrent