GABAPENTIN

Product NDC
49483-606
11-digit product format
494830606
Labeler code
49483
Product ID
49483-606_39a5daea-e195-c00b-e063-6394a90a42a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
TIME CAP LABORATORIES, INC
Application
ANDA090007
Marketing category
ANDA
Marketing start
2015-12-30
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
GABAPENTIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310430, 310431, 310432

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49483-606-01GABAPENTIN100 in 1 BOTTLECAPSULE10010
49483-606-10GABAPENTIN1000 in 1 BOTTLECAPSULE100010
49483-606-50GABAPENTIN500 in 1 BOTTLECAPSULE50010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49483-606-01EA - Each49483-6064e9edb99-1ad9-432a-a9c6-3fedef6c4fe012016-05-16
49483-606-10EA - Each49483-606e4dbd10f-f71c-419f-806d-95db7517babb12021-06-02
49483-606-50EA - Each49483-6062d45f7da-94ff-4495-b091-90adf7deda6e12016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [DIRECT RX]4
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [DIRECT RX]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGABAPENTIN CAPSULE [DIRECT RX]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGABAPENTIN CAPSULE [DIRECT RX]4
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN CAPSULE [DIRECT RX]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [DIRECT RX]4
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN CAPSULE [DIRECT RX]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [DIRECT RX]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-606GABAPENTIN CAPSULE GABAPENTIN CAPSULE [TIME CAP LABORATORIES, INC]9Current NDC, Legacy NDC, 3 package rows20241013_08880902-bd44-41b6-866b-2cbad4c3f2b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN08880902-bd44-41b6-866b-2cbad4c3f2b110
310431gabapentin 300 MG Oral CapsulePSN08880902-bd44-41b6-866b-2cbad4c3f2b110
310432gabapentin 400 MG Oral CapsulePSN08880902-bd44-41b6-866b-2cbad4c3f2b110
310430gabapentin 100 MG Oral CapsuleSCD08880902-bd44-41b6-866b-2cbad4c3f2b110
310431gabapentin 300 MG Oral CapsuleSCD08880902-bd44-41b6-866b-2cbad4c3f2b110
310432gabapentin 400 MG Oral CapsuleSCD08880902-bd44-41b6-866b-2cbad4c3f2b110
310431gabapentin 300 MG Oral CapsulePSNb062f12c-a745-76d4-e053-2a95a90a3a1a8
310431gabapentin 300 MG Oral CapsulePSN29a70e2d-d3fd-4e32-95dd-7ee721d873888
310431gabapentin 300 MG Oral CapsuleSCDb062f12c-a745-76d4-e053-2a95a90a3a1a8
310431gabapentin 300 MG Oral CapsuleSCD29a70e2d-d3fd-4e32-95dd-7ee721d873888
310431gabapentin 300 MG Oral CapsulePSN78088f6a-06a3-422f-b336-4a57a24adc166
310431gabapentin 300 MG Oral CapsulePSN11645bd6-7cfe-49b2-9292-2e4b0dbb84ae6
310431gabapentin 300 MG Oral CapsulePSNc33c4d83-cc13-4104-9e24-d4cd40b17b706
310431gabapentin 300 MG Oral CapsuleSCD78088f6a-06a3-422f-b336-4a57a24adc166
310431gabapentin 300 MG Oral CapsuleSCDc33c4d83-cc13-4104-9e24-d4cd40b17b706
310431gabapentin 300 MG Oral CapsuleSCD11645bd6-7cfe-49b2-9292-2e4b0dbb84ae6
310431gabapentin 300 MG Oral CapsulePSNd359f72b-dbf4-473f-8d1e-1e9a961793665
310431gabapentin 300 MG Oral CapsuleSCDd359f72b-dbf4-473f-8d1e-1e9a961793665
310431gabapentin 300 MG Oral CapsulePSN82c0ed15-9132-657d-e053-2991aa0ae90a4
310431gabapentin 300 MG Oral CapsuleSCD82c0ed15-9132-657d-e053-2991aa0ae90a4
310431gabapentin 300 MG Oral CapsulePSN907853a0-9979-62e7-e053-2995a90a5aca3
310431gabapentin 300 MG Oral CapsulePSN88ddd50d-1762-2880-e053-2995a90adf673
310431gabapentin 300 MG Oral CapsuleSCD907853a0-9979-62e7-e053-2995a90a5aca3
310431gabapentin 300 MG Oral CapsuleSCD88ddd50d-1762-2880-e053-2995a90adf673
310431gabapentin 300 MG Oral CapsulePSN8f9fc8a2-0d10-12f1-e053-2995a90acf3d1
310431gabapentin 300 MG Oral CapsulePSN9d1b9121-c25a-4d28-91c5-5fc72f1167f41
310431gabapentin 300 MG Oral CapsulePSN8f9fbc86-2027-b203-e053-2a95a90af2991
310431gabapentin 300 MG Oral CapsuleSCD8f9fc8a2-0d10-12f1-e053-2995a90acf3d1
310431gabapentin 300 MG Oral CapsuleSCD9d1b9121-c25a-4d28-91c5-5fc72f1167f41
310431gabapentin 300 MG Oral CapsuleSCD8f9fbc86-2027-b203-e053-2a95a90af2991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49483-606-0149483060601100 CAPSULE in 1 BOTTLE (49483-606-01) 100 capsule2015-12-300000-00-00NoNoCurrent
49483-606-10494830606101000 CAPSULE in 1 BOTTLE (49483-606-10) 1000 capsule2021-04-170000-00-00NoNoCurrent
49483-606-5049483060650500 CAPSULE in 1 BOTTLE (49483-606-50) 500 capsule2015-12-300000-00-00NoNoCurrent