FDA.reportPublic FDA data

Gabapentin

Product NDC
42385-980
11-digit product format
423850980
Labeler code
42385
Product ID
42385-980_7a649a0a-d3ca-48e4-af76-f9adf3fa6c4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Laurus Labs Limited
Application
ANDA217965
Marketing category
ANDA
Marketing start
2024-04-09
Substance
GABAPENTIN
Active strength
800 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217965-001GABAPENTINGABAPENTIN600MGTABLET / ORALAB12024-04-08
A217965-002GABAPENTINGABAPENTIN800MGTABLET / ORALAB12024-04-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A217965-001AB1
A217965-002AB1

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A217965-001GABAPENTIN600MGTABLET / ORALAB12024-04-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217965-002GABAPENTIN800MGTABLET / ORALAB12024-04-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217965-001GABAPENTIN600MGTABLET / ORALAB12024-04-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217965-002GABAPENTIN800MGTABLET / ORALAB12024-04-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A217965-001GABAPENTIN600MGTABLET / ORALAB12024-04-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217965-002GABAPENTIN800MGTABLET / ORALAB12024-04-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217965-001GABAPENTIN600MGTABLET / ORALAB12024-04-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217965-002GABAPENTIN800MGTABLET / ORALAB12024-04-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217965-001GABAPENTIN600MGTABLET / ORALAB12024-04-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217965-002GABAPENTIN800MGTABLET / ORALAB12024-04-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217965-001GABAPENTIN600MGTABLET / ORALAB12024-04-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217965-002GABAPENTIN800MGTABLET / ORALAB12024-04-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217965-001GABAPENTIN600MGTABLET / ORALAB12024-04-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217965-002GABAPENTIN800MGTABLET / ORALAB12024-04-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217965-001GABAPENTIN600MGTABLET / ORALAB12024-04-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217965-002GABAPENTIN800MGTABLET / ORALAB12024-04-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217965-001GABAPENTIN600MGTABLET / ORALAB12024-04-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217965-002GABAPENTIN800MGTABLET / ORALAB12024-04-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217965-001GABAPENTIN600MGTABLET / ORALAB12024-04-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A217965-002GABAPENTIN800MGTABLET / ORALAB12024-04-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217965-001GABAPENTIN600MGTABLET / ORALAB12024-04-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217965-002GABAPENTIN800MGTABLET / ORALAB12024-04-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217965-001GABAPENTIN600MGTABLET / ORALAB12024-04-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217965-002GABAPENTIN800MGTABLET / ORALAB12024-04-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217965-001GABAPENTIN600MGTABLET / ORALAB12024-04-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217965-002GABAPENTIN800MGTABLET / ORALAB12024-04-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217965-001GABAPENTIN600MGTABLET / ORALAB12024-04-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05A217965-002GABAPENTIN800MGTABLET / ORALAB12024-04-088072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217965-001GABAPENTIN600MGTABLET / ORALAB12024-04-08a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217965-002GABAPENTIN800MGTABLET / ORALAB12024-04-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A217965-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217965-002AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217965-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217965-002AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217965-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217965-002AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217965-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217965-002AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217965-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217965-002AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217965-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217965-002AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217965-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217965-002AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217965-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217965-002AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217965-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217965-002AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217965-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A217965-002AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217965-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217965-002AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217965-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217965-002AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217965-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217965-002AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217965-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A217965-002AB118072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217965-001AB11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217965-002AB11a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Gabapentin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN800 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6CW7F3G59XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310430Internal RxNorm lookup
310431Internal RxNorm lookup
310432Internal RxNorm lookup
310433Internal RxNorm lookup
310434Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
07aa1bcc-df05-44fa-92d4-63894e0e6cd6Available on FDA.report

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42385-980-01Gabapentin100 in 1 BOTTLETABLET, FILM COATED1003
42385-980-05Gabapentin500 in 1 BOTTLETABLET, FILM COATED5003
42385-980-11Gabapentin1000 in 1 BOTTLETABLET, FILM COATED10003
42385-980-30Gabapentin30 in 1 BOTTLETABLET, FILM COATED303
42385-980-72Gabapentin10 in 1 CARTONTABLET, FILM COATED103
42385-980-72Gabapentin10 in 1 BLISTER PACKTABLET, FILM COATED103
42385-980-90Gabapentin90 in 1 BOTTLETABLET, FILM COATED903
42385-980-01Gabapentin100 in 1 BOTTLETABLET, FILM COATED1002
42385-980-05Gabapentin500 in 1 BOTTLETABLET, FILM COATED5002
42385-980-11Gabapentin1000 in 1 BOTTLETABLET, FILM COATED10002
42385-980-17Gabapentin10 in 1 BLISTER PACKTABLET, FILM COATED102
42385-980-30Gabapentin30 in 1 BOTTLETABLET, FILM COATED302
42385-980-72Gabapentin10 in 1 CARTONTABLET, FILM COATED102
42385-980-90Gabapentin90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42385-980GABAPENTIN TABLET, FILM COATED [LAURUS LABS LIMITED]2Current NDC, 7 package rows20240723_63639720-7f93-46c0-848d-4c976889010d.zip

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINLaurus Labs Limited07aa1bcc-df05-44fa-92d4-63894e0e6cd62026-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217965
application number: ANDA217965
ndc (product): 42385-980

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN07aa1bcc-df05-44fa-92d4-63894e0e6cd64
310431gabapentin 300 MG Oral CapsulePSN07aa1bcc-df05-44fa-92d4-63894e0e6cd64
310432gabapentin 400 MG Oral CapsulePSN07aa1bcc-df05-44fa-92d4-63894e0e6cd64
310433gabapentin 600 MG Oral TabletPSN07aa1bcc-df05-44fa-92d4-63894e0e6cd64
310434gabapentin 800 MG Oral TabletPSN07aa1bcc-df05-44fa-92d4-63894e0e6cd64
310430gabapentin 100 MG Oral CapsuleSCD07aa1bcc-df05-44fa-92d4-63894e0e6cd64
310431gabapentin 300 MG Oral CapsuleSCD07aa1bcc-df05-44fa-92d4-63894e0e6cd64
310432gabapentin 400 MG Oral CapsuleSCD07aa1bcc-df05-44fa-92d4-63894e0e6cd64
310433gabapentin 600 MG Oral TabletSCD07aa1bcc-df05-44fa-92d4-63894e0e6cd64
310434gabapentin 800 MG Oral TabletSCD07aa1bcc-df05-44fa-92d4-63894e0e6cd64
310433gabapentin 600 MG Oral TabletPSN63639720-7f93-46c0-848d-4c976889010d2
310434gabapentin 800 MG Oral TabletPSN63639720-7f93-46c0-848d-4c976889010d2
310433gabapentin 600 MG Oral TabletSCD63639720-7f93-46c0-848d-4c976889010d2
310434gabapentin 800 MG Oral TabletSCD63639720-7f93-46c0-848d-4c976889010d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42385-980-0142385098001100 TABLET, FILM COATED in 1 BOTTLE (42385-980-01) 2024-04-09NoNoCurrent
42385-980-0542385098005500 TABLET, FILM COATED in 1 BOTTLE (42385-980-05) 2024-04-09NoNoCurrent
42385-980-11423850980111000 TABLET, FILM COATED in 1 BOTTLE (42385-980-11) 2024-04-09NoNoCurrent
42385-980-174238509801710 in 1 BLISTER PACKHistorical
42385-980-304238509803030 TABLET, FILM COATED in 1 BOTTLE (42385-980-30) 2024-04-09NoNoCurrent
42385-980-724238509807210 BLISTER PACK in 1 CARTON (42385-980-72) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2024-04-09NoNoCurrent
42385-980-904238509809090 TABLET, FILM COATED in 1 BOTTLE (42385-980-90) 2024-04-09NoNoCurrent