FDA.reportPublic FDA data

gabapentin

Product NDC
70771-1861
11-digit product format
707711861
Labeler code
70771
Product ID
70771-1861_ba40713a-2f22-4276-a664-355e7442cda4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA203934
Marketing category
ANDA
Marketing start
2024-01-25
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
Rxcui1806380, 1806382, 2634743, 2634747, 2634751

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
70771-1861-2gabapentin10 in 1 BLISTER PACKTABLET103
70771-1861-5gabapentin500 in 1 BOTTLETABLET5003
70771-1861-9gabapentin90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1861GABAPENTIN TABLET [ZYDUS LIFESCIENCES LIMITED]2Current NDC, 3 package rows20241201_8c0eeefc-ef5b-49f4-8411-ddbae312ed05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1806380gabapentin 300 MG Once-Daily Oral TabletPSN8c0eeefc-ef5b-49f4-8411-ddbae312ed053
2634747gabapentin 450 MG Once-Daily Oral TabletPSN8c0eeefc-ef5b-49f4-8411-ddbae312ed053
1806382gabapentin 600 MG Once-Daily Oral TabletPSN8c0eeefc-ef5b-49f4-8411-ddbae312ed053
2634751gabapentin 750 MG Once-Daily Oral TabletPSN8c0eeefc-ef5b-49f4-8411-ddbae312ed053
2634743gabapentin 900 MG Once-Daily Oral TabletPSN8c0eeefc-ef5b-49f4-8411-ddbae312ed053
1806380Once-Daily gabapentin 300 MG Oral TabletSCD8c0eeefc-ef5b-49f4-8411-ddbae312ed053
2634747Once-Daily gabapentin 450 MG Oral TabletSCD8c0eeefc-ef5b-49f4-8411-ddbae312ed053
1806382Once-Daily gabapentin 600 MG Oral TabletSCD8c0eeefc-ef5b-49f4-8411-ddbae312ed053
2634751Once-Daily gabapentin 750 MG Oral TabletSCD8c0eeefc-ef5b-49f4-8411-ddbae312ed053
2634743Once-Daily gabapentin 900 MG Oral TabletSCD8c0eeefc-ef5b-49f4-8411-ddbae312ed053
1806380gabapentin 300 MG Once-Daily Oral TabletSY8c0eeefc-ef5b-49f4-8411-ddbae312ed053
2634747gabapentin 450 MG Once-Daily Oral TabletSY8c0eeefc-ef5b-49f4-8411-ddbae312ed053
1806382gabapentin 600 MG Once-Daily Oral TabletSY8c0eeefc-ef5b-49f4-8411-ddbae312ed053
2634751gabapentin 750 MG Once-Daily Oral TabletSY8c0eeefc-ef5b-49f4-8411-ddbae312ed053
2634743gabapentin 900 MG Once-Daily Oral TabletSY8c0eeefc-ef5b-49f4-8411-ddbae312ed053

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70771-1861-27077118610210 TABLET in 1 BLISTER PACK (70771-1861-2) 10 tablet2024-01-25NoNoHistorical
70771-1861-570771186105500 TABLET in 1 BOTTLE (70771-1861-5) 500 tablet2024-01-25NoNoHistorical
70771-1861-97077118610990 TABLET in 1 BOTTLE (70771-1861-9) 90 tablet2024-01-25NoNoHistorical