FDA.reportPublic FDA data

NDC 61919-101-90 - GABAPENTIN

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
61919-101
Requested NDC
61919-101-90
Package NDCs from labels
61919-101-30, 61919-101-60, 61919-101-90, 61919-101-72
Manufacturer
Direct Rx
Effective date
2015-08-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
GABAPENTIN - Direct RxDirect Rx2015-08-13HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-101-722020-01-31C16284748780-19d75b9d0-7987-f424-e053-dadaa90a57ceGABAPENTIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-101-30GABAPENTIN30 in 1 BOTTLECAPSULE302
61919-101-60GABAPENTIN60 in 1 BOTTLECAPSULE602
61919-101-72GABAPENTIN120 in 1 BOTTLECAPSULE1202
61919-101-90GABAPENTIN90 in 1 BOTTLECAPSULE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-101GABAPENTIN CAPSULE [DIRECT RX]2Legacy NDC, 4 package rows20150814_52e49778-03f1-43cb-b75d-6c1adbb96ec6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-101-30EA - Each61919-1018daf6c09-f3d2-451c-9d97-3613aa1f984912014-05-02
61919-101-60EA - Each61919-1011020acc8-ab59-470d-a97e-762adc23572d12014-05-02
61919-101-72EA - Each61919-10132d37f10-37c0-40ad-8dff-a4404f53ea8e12014-05-02
61919-101-90EA - Each61919-10131cf34df-f040-44e4-9571-e9e739e0678712014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [DIRECT RX]2
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [DIRECT RX]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MGABAPENTIN CAPSULE [DIRECT RX]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XGABAPENTIN CAPSULE [DIRECT RX]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3GABAPENTIN CAPSULE [DIRECT RX]2
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKGABAPENTIN CAPSULE [DIRECT RX]2
CALCIUM SULFATE DIHYDRATEINACTIVE INGREDIENT4846Q921YMGABAPENTIN CAPSULE [DIRECT RX]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GABAPENTIN CAPSULE [DIRECT RX]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGABAPENTIN CAPSULE [DIRECT RX]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GABAPENTIN CAPSULE [DIRECT RX]2
GELATININACTIVE INGREDIENT2G86QN327LGABAPENTIN CAPSULE [DIRECT RX]2
GLYCERYL BEHENATEINACTIVE INGREDIENTR8WTH25YS2GABAPENTIN CAPSULE [DIRECT RX]2
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2GABAPENTIN CAPSULE [DIRECT RX]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302GABAPENTIN CAPSULE [DIRECT RX]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TGABAPENTIN CAPSULE [DIRECT RX]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GABAPENTIN CAPSULE [DIRECT RX]2
SHELLACINACTIVE INGREDIENT46N107B71OGABAPENTIN CAPSULE [DIRECT RX]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGABAPENTIN CAPSULE [DIRECT RX]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [DIRECT RX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [DIRECT RX]2
WATERINACTIVE INGREDIENT059QF0KO0RGABAPENTIN CAPSULE [DIRECT RX]2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 341 · 6,804 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hydrating mist hand sanitizer with silicone keychain holder - beaver nuggetsALCOHOLGanzhou Olivee Cosmetic Co., Ltd.ba3612b3-9696-417a-ba66-eb9dc5ea27c62026-09-07WarningsExact identifier
unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - signature scentALCOHOLGanzhou Olivee Cosmetic Co., Ltd.5b0ac694-66e0-437f-86cd-09f259344b892026-09-07WarningsExact identifier
unii: 3K9958V90M
ALCOHOL PREP PADS MEDIUM STERILEISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD57cbbe72-24ec-2e4a-e063-6394a90abbd22026-09-07WarningsExact identifier
unii: ND2M416302
Regular Strength Tropical FruitCALCIUM CARBONATERARITAN PHARMACEUTICALS INC38c6cece-71a0-40d8-bfc8-2f6467f9239b2026-09-05WarningsExact identifier
unii: H0G9379FGK
Sweethearts - Crush On You - Peach SkinALCOHOLScent Theory Products LLC5ac32582-d888-edf4-e063-6394a90a40ab2026-09-05WarningsExact identifier
unii: 3K9958V90M
Sweethearts - Be Mine - Sugared BerriesALCOHOLScent Theory Products LLC5ac32ffb-926a-f249-e063-6394a90a8d872026-09-05WarningsExact identifier
unii: 3K9958V90M
Sweethearts - UR Sweet - Sweet Cherry Hand SanitizerALCOHOLScent Theory Products LLC5ac33b21-9192-8baa-e063-6294a90a6e752026-09-05WarningsExact identifier
unii: 3K9958V90M
Sweethearts - Ooo La La - Banana Cream Hand SanitizerALCOHOLScent Theory Products LLC5ac34dda-fbdf-0ca7-e063-6394a90ab7642026-09-05WarningsExact identifier
unii: 3K9958V90M
Extra Strength Antacid Assorted BerriesCALCIUM CARBONATERARITAN PHARMACEUTICALS INC07a50168-6b05-4c99-9969-7d7f0aa54f302026-09-05WarningsExact identifier
unii: H0G9379FGK
DRx CHOICE Antacid Calcium Regular StrengthCALCIUM CARBONATE 500MGRaritan Pharmaceuticals Inc0c579405-9397-4bf2-8441-e89011b19ec42026-09-05WarningsExact identifier
unii: H0G9379FGK
SurviveX PREP WIPESALCOHOL PREP PADChangzhou Maokang Medical Products Co., Ltd.5a7e9dc6-cf43-7ffc-e063-6394a90a3faa2026-09-04WarningsExact identifier
unii: ND2M416302
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Touchland Power Mist Salted Caramel Scented Hydrating Hand sanitizerALCOHOLChurch & Dwight Co., Inc.5aaa5f5b-7a8b-e887-e063-6294a90a9be52026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Peppermint Mocha Scented Hydrating Hand sanitizerALCOHOLChurch & Dwight Co., Inc.5aaa72fe-7667-fb21-e063-6294a90a5e112026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Spiced Pumpkin tini Scented Hydrating Hand sanitizerALCOHOLChurch & Dwight Co., Inc.5aaa809e-71b8-7498-e063-6394a90a9ff82026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Hello Kitty Power Mist Hand Sanitizer Berry BlissALCOHOLChurch & Dwight Co., Inc.5aaa8d3c-e386-1527-e063-6294a90a07ac2026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Cinnamon GingerbreadALCOHOLChurch & Dwight Co., Inc.5aaa9d84-3f84-223e-e063-6294a90a79fb2026-09-04WarningsExact identifier
unii: 3K9958V90M
Disney Touchland Power Mist Hydrating Hand Sanitizer Wild WatermelonALCOHOLChurch & Dwight Co., Inc.5aaab1c9-c25c-344a-e063-6294a90a228d2026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Confetti CakeALCOHOLChurch & Dwight Co., Inc.5aaacef6-3b8b-ace4-e063-6394a90ab8592026-09-04WarningsExact identifier
unii: 3K9958V90M
Disney Touchland Power Mist Hydrating Hand Sanitizer Vanilla BlossomALCOHOLChurch & Dwight Co., Inc.5aaae919-4adc-c146-e063-6394a90a89042026-09-04WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.