Gabapentin

Product NDC
65162-101
11-digit product format
651620101
Labeler code
65162
Product ID
65162-101_385f01e9-5b50-41d8-a2d5-748f5f84c027
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA078428
Marketing category
ANDA
Marketing start
2009-11-24
Substance
GABAPENTIN
Active strength
100 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078428-001GABAPENTINGABAPENTIN100MGCAPSULE / ORALAB2007-07-25
A078428-002GABAPENTINGABAPENTIN300MGCAPSULE / ORALAB2007-07-25
A078428-003GABAPENTINGABAPENTIN400MGCAPSULE / ORALAB2007-07-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A078428-001AB
A078428-002AB
A078428-003AB

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.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078428-001GABAPENTIN100MGCAPSULE / ORALAB2007-07-2584e616aacf4f…
2026-09-14 22:38:342026-08A078428-002GABAPENTIN300MGCAPSULE / ORALAB2007-07-2584e616aacf4f…
2026-09-14 22:38:342026-08A078428-003GABAPENTIN400MGCAPSULE / ORALAB2007-07-2584e616aacf4f…
2026-08-18 06:07:402026-07A078428-001GABAPENTIN100MGCAPSULE / ORALAB2007-07-25caaa826d4ba7…
2026-08-18 06:07:402026-07A078428-002GABAPENTIN300MGCAPSULE / ORALAB2007-07-25caaa826d4ba7…
2026-08-18 06:07:402026-07A078428-003GABAPENTIN400MGCAPSULE / ORALAB2007-07-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078428-001GABAPENTIN100MGCAPSULE / ORALAB2007-07-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078428-002GABAPENTIN300MGCAPSULE / ORALAB2007-07-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078428-003GABAPENTIN400MGCAPSULE / ORALAB2007-07-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078428-001GABAPENTIN100MGCAPSULE / ORALAB2007-07-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078428-002GABAPENTIN300MGCAPSULE / ORALAB2007-07-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078428-003GABAPENTIN400MGCAPSULE / ORALAB2007-07-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078428-001GABAPENTIN100MGCAPSULE / ORALAB2007-07-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078428-002GABAPENTIN300MGCAPSULE / ORALAB2007-07-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078428-003GABAPENTIN400MGCAPSULE / ORALAB2007-07-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078428-001GABAPENTIN100MGCAPSULE / ORALAB2007-07-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078428-002GABAPENTIN300MGCAPSULE / ORALAB2007-07-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078428-003GABAPENTIN400MGCAPSULE / ORALAB2007-07-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078428-001GABAPENTIN100MGCAPSULE / ORALAB2007-07-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078428-002GABAPENTIN300MGCAPSULE / ORALAB2007-07-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078428-003GABAPENTIN400MGCAPSULE / ORALAB2007-07-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078428-001GABAPENTIN100MGCAPSULE / ORALAB2007-07-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078428-002GABAPENTIN300MGCAPSULE / ORALAB2007-07-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078428-003GABAPENTIN400MGCAPSULE / ORALAB2007-07-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078428-001GABAPENTIN100MGCAPSULE / ORALAB2007-07-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078428-002GABAPENTIN300MGCAPSULE / ORALAB2007-07-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078428-003GABAPENTIN400MGCAPSULE / ORALAB2007-07-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078428-001GABAPENTIN100MGCAPSULE / ORALAB2007-07-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078428-002GABAPENTIN300MGCAPSULE / ORALAB2007-07-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078428-003GABAPENTIN400MGCAPSULE / ORALAB2007-07-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078428-001GABAPENTIN100MGCAPSULE / ORALAB2007-07-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078428-002GABAPENTIN300MGCAPSULE / ORALAB2007-07-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078428-003GABAPENTIN400MGCAPSULE / ORALAB2007-07-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078428-001GABAPENTIN100MGCAPSULE / ORALAB2007-07-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A078428-002GABAPENTIN300MGCAPSULE / ORALAB2007-07-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A078428-003GABAPENTIN400MGCAPSULE / ORALAB2007-07-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078428-001GABAPENTIN100MGCAPSULE / ORALAB2007-07-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078428-002GABAPENTIN300MGCAPSULE / ORALAB2007-07-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078428-003GABAPENTIN400MGCAPSULE / ORALAB2007-07-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078428-001GABAPENTIN100MGCAPSULE / ORALAB2007-07-25301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A078428-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078428-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A078428-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A078428-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078428-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078428-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078428-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078428-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078428-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078428-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078428-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078428-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078428-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078428-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078428-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078428-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078428-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078428-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078428-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078428-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078428-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078428-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078428-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078428-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078428-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078428-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078428-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078428-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078428-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078428-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078428-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078428-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078428-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078428-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078428-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078428-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078428-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078428-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078428-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078428-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN100 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 · 3 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
507bf6d0-e7a2-413d-9848-cd2445a1411dAvailable 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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-101-03Gabapentin30 in 1 BOTTLECAPSULE3036
65162-101-10Gabapentin100 in 1 BOTTLECAPSULE10036
65162-101-11Gabapentin1000 in 1 BOTTLECAPSULE100036
65162-101-50Gabapentin500 in 1 BOTTLECAPSULE50036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-101-10EA - Each65162-1016439d67d-d1ed-4328-82ba-86ada254331312014-07-02
65162-101-11EA - Each65162-101d067c3dd-5f1e-445a-9888-c3800775d1bb12014-07-02
65162-101-50EA - Each65162-1017236362e-d696-4335-b8f1-498de18860da12014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]24
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]24
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-101GABAPENTIN CAPSULE [AMNEAL PHARMACEUTICALS LLC]35Current NDC, Legacy NDC, 4 package rows20250201_507bf6d0-e7a2-413d-9848-cd2445a1411d.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINUnit Dose Solutions, Inc.54dc347e-cba0-ea73-e063-6294a90ab4362026-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078428
application number: ANDA078428
GabapentinGABAPENTINAmneal Pharmaceuticals LLC507bf6d0-e7a2-413d-9848-cd2445a1411d2026-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078428
application number: ANDA078428
ndc (product): 65162-101
GabapentinGABAPENTINBryant Ranch Prepack7b404ab9-8a7e-49d4-920f-487875d14e452024-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078428
application number: ANDA078428
GabapentinGABAPENTINBryant Ranch Prepack657349fb-41a9-4814-b4ac-4c5afbdde9472024-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078428
application number: ANDA078428
GabapentinGABAPENTINBryant Ranch Prepacka15d5dcc-63c4-4c06-ab91-5e22cdf234cc2024-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078428
application number: ANDA078428
GabapentinGABAPENTINBryant Ranch Prepack477691f5-0591-4544-840a-ac590e1f25a12024-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078428
application number: ANDA078428
GabapentinGABAPENTINBryant Ranch Prepack506bf880-9564-404c-951a-703797ffdad82024-10-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078428
application number: ANDA078428
GabapentinGABAPENTINClinical Solutions Wholesale, LLCdbedccfb-0e27-4119-93b9-241c039e045a2024-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078428
application number: ANDA078428
GabapentinGABAPENTINAmneal Pharmaceuticals of New York LLCb11dbff5-ceee-4a63-a093-f6efebdc2f6f2021-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078428
application number: ANDA078428

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN507bf6d0-e7a2-413d-9848-cd2445a1411d36
310431gabapentin 300 MG Oral CapsulePSN507bf6d0-e7a2-413d-9848-cd2445a1411d36
310432gabapentin 400 MG Oral CapsulePSN507bf6d0-e7a2-413d-9848-cd2445a1411d36
310430gabapentin 100 MG Oral CapsuleSCD507bf6d0-e7a2-413d-9848-cd2445a1411d36
310431gabapentin 300 MG Oral CapsuleSCD507bf6d0-e7a2-413d-9848-cd2445a1411d36
310432gabapentin 400 MG Oral CapsuleSCD507bf6d0-e7a2-413d-9848-cd2445a1411d36
310430gabapentin 100 MG Oral CapsulePSN26a59a2d-a007-2fe3-e063-6394a90aadd21
310430gabapentin 100 MG Oral CapsulePSNc77abf60-4ee5-44cf-a518-723ffd4c2dcb1
310430gabapentin 100 MG Oral CapsulePSNdbedccfb-0e27-4119-93b9-241c039e045a1
310431gabapentin 300 MG Oral CapsulePSNdbedccfb-0e27-4119-93b9-241c039e045a1
310432gabapentin 400 MG Oral CapsulePSNdbedccfb-0e27-4119-93b9-241c039e045a1
310430gabapentin 100 MG Oral CapsuleSCD26a59a2d-a007-2fe3-e063-6394a90aadd21
310430gabapentin 100 MG Oral CapsuleSCDc77abf60-4ee5-44cf-a518-723ffd4c2dcb1
310430gabapentin 100 MG Oral CapsuleSCDdbedccfb-0e27-4119-93b9-241c039e045a1
310431gabapentin 300 MG Oral CapsuleSCDdbedccfb-0e27-4119-93b9-241c039e045a1
310432gabapentin 400 MG Oral CapsuleSCDdbedccfb-0e27-4119-93b9-241c039e045a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-101-036516201010330 CAPSULE in 1 BOTTLE (65162-101-03) 30 capsule2009-11-240000-00-00NoNoCurrent
65162-101-1065162010110100 CAPSULE in 1 BOTTLE (65162-101-10) 100 capsule2009-11-240000-00-00NoNoCurrent
65162-101-11651620101111000 CAPSULE in 1 BOTTLE (65162-101-11) 1000 capsule2009-11-240000-00-00NoNoCurrent
65162-101-5065162010150500 CAPSULE in 1 BOTTLE (65162-101-50) 500 capsule2009-11-240000-00-00NoNoCurrent