Gabapentin

Product NDC
71335-1375
Requested package NDC
71335-1375-2
11-digit product format
713351375
Labeler code
71335
Product ID
71335-1375_017348ea-f17f-40e2-8346-6607e34ed94a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206943
Marketing category
ANDA
Marketing start
2018-05-14
Substance
GABAPENTIN
Active strength
100 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71335-137571335-1375-2DDiscontinued by firm2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A206943-001GABAPENTINGABAPENTIN100MGCAPSULE / ORALAB2018-05-14
A206943-002GABAPENTINGABAPENTIN300MGCAPSULE / ORALAB2018-05-14
A206943-003GABAPENTINGABAPENTIN400MGCAPSULE / ORALAB2018-05-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206943-001AB
A206943-002AB
A206943-003AB

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A206943-001GABAPENTIN100MGCAPSULE / ORALAB2018-05-14c2088c7a36db…
2026-10-15 13:18:302026-09A206943-002GABAPENTIN300MGCAPSULE / ORALAB2018-05-14c2088c7a36db…
2026-10-15 13:18:302026-09A206943-003GABAPENTIN400MGCAPSULE / ORALAB2018-05-14c2088c7a36db…
2026-09-14 22:38:342026-08A206943-001GABAPENTIN100MGCAPSULE / ORALAB2018-05-1484e616aacf4f…
2026-09-14 22:38:342026-08A206943-002GABAPENTIN300MGCAPSULE / ORALAB2018-05-1484e616aacf4f…
2026-09-14 22:38:342026-08A206943-003GABAPENTIN400MGCAPSULE / ORALAB2018-05-1484e616aacf4f…
2026-08-18 06:07:402026-07A206943-001GABAPENTIN100MGCAPSULE / ORALAB2018-05-14caaa826d4ba7…
2026-08-18 06:07:402026-07A206943-002GABAPENTIN300MGCAPSULE / ORALAB2018-05-14caaa826d4ba7…
2026-08-18 06:07:402026-07A206943-003GABAPENTIN400MGCAPSULE / ORALAB2018-05-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206943-001GABAPENTIN100MGCAPSULE / ORALAB2018-05-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206943-002GABAPENTIN300MGCAPSULE / ORALAB2018-05-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206943-003GABAPENTIN400MGCAPSULE / ORALAB2018-05-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206943-001GABAPENTIN100MGCAPSULE / ORALAB2018-05-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206943-002GABAPENTIN300MGCAPSULE / ORALAB2018-05-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206943-003GABAPENTIN400MGCAPSULE / ORALAB2018-05-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A206943-001GABAPENTIN100MGCAPSULE / ORALAB2018-05-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206943-002GABAPENTIN300MGCAPSULE / ORALAB2018-05-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206943-003GABAPENTIN400MGCAPSULE / ORALAB2018-05-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206943-001GABAPENTIN100MGCAPSULE / ORALAB2018-05-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206943-002GABAPENTIN300MGCAPSULE / ORALAB2018-05-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206943-003GABAPENTIN400MGCAPSULE / ORALAB2018-05-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206943-001GABAPENTIN100MGCAPSULE / ORALAB2018-05-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206943-002GABAPENTIN300MGCAPSULE / ORALAB2018-05-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206943-003GABAPENTIN400MGCAPSULE / ORALAB2018-05-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206943-001GABAPENTIN100MGCAPSULE / ORALAB2018-05-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206943-002GABAPENTIN300MGCAPSULE / ORALAB2018-05-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206943-003GABAPENTIN400MGCAPSULE / ORALAB2018-05-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206943-001GABAPENTIN100MGCAPSULE / ORALAB2018-05-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206943-002GABAPENTIN300MGCAPSULE / ORALAB2018-05-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206943-003GABAPENTIN400MGCAPSULE / ORALAB2018-05-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206943-001GABAPENTIN100MGCAPSULE / ORALAB2018-05-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206943-002GABAPENTIN300MGCAPSULE / ORALAB2018-05-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206943-003GABAPENTIN400MGCAPSULE / ORALAB2018-05-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206943-001GABAPENTIN100MGCAPSULE / ORALAB2018-05-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206943-002GABAPENTIN300MGCAPSULE / ORALAB2018-05-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206943-003GABAPENTIN400MGCAPSULE / ORALAB2018-05-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206943-001GABAPENTIN100MGCAPSULE / ORALAB2018-05-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A206943-002GABAPENTIN300MGCAPSULE / ORALAB2018-05-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A206943-003GABAPENTIN400MGCAPSULE / ORALAB2018-05-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206943-001GABAPENTIN100MGCAPSULE / ORALAB2018-05-1479d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A206943-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A206943-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A206943-003AB1c2088c7a36db…
2026-09-14 22:38:342026-08A206943-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A206943-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A206943-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A206943-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206943-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206943-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206943-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206943-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206943-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206943-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206943-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206943-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206943-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206943-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206943-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206943-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206943-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206943-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206943-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206943-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206943-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206943-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206943-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206943-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206943-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206943-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206943-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206943-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206943-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206943-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206943-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206943-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206943-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206943-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206943-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206943-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206943-001AB179d66fd596c7…

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
2026-12-31

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
38210141-bbdc-4186-b71f-54c72f794dcaAvailable 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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1375-1Gabapentin90 in 1 BOTTLECAPSULE90102
71335-1375-2Gabapentin28 in 1 BOTTLECAPSULE28102
71335-1375-3Gabapentin30 in 1 BOTTLECAPSULE30102
71335-1375-4Gabapentin60 in 1 BOTTLECAPSULE60102
71335-1375-5Gabapentin120 in 1 BOTTLECAPSULE120102
71335-1375-6Gabapentin84 in 1 BOTTLECAPSULE84102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1375-3EA - Each71335-1375f42862b3-032b-44fb-8346-3812bbe8cf9a12020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1375GABAPENTIN CAPSULE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 6 package rows20240410_38210141-bbdc-4186-b71f-54c72f794dca.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 2 of 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINBryant Ranch Prepack9efd0261-9fc9-4dc9-8cf3-9110157ddfc42024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206943
application number: ANDA206943
GabapentinGABAPENTINBryant Ranch Prepack01b810b7-f4c8-4412-bbc5-b9220d8770d82024-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206943
application number: ANDA206943
GabapentinGABAPENTINMedsource Pharmaceuticals1278512b-1493-db65-e063-6394a90ab1612024-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206943
application number: ANDA206943
GabapentinGABAPENTINBryant Ranch Prepacke286ed87-5fbc-4ff2-a05e-1f7fa658bbfc2023-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206943
application number: ANDA206943
GabapentinGABAPENTINProficient Rx LP645824d0-eb3d-442b-806d-36a70796cb8e2022-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206943
application number: ANDA206943

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN38210141-bbdc-4186-b71f-54c72f794dca102
310430gabapentin 100 MG Oral CapsuleSCD38210141-bbdc-4186-b71f-54c72f794dca102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1375-27133513750228 CAPSULE in 1 BOTTLE (71335-1375-2) 28 capsule2024-04-030000-00-00NoNoCurrent