GABAPENTIN

Manufacturer
NuCare Pharmaceuticals, Inc.
Effective date
2021-02-10
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:53:36

Label at a glance#

ProductGABAPENTIN
Active ingredientGABAPENTIN
Label structure2 sections

Label contents#

Full prescribing information#

HOW SUPPLIED

SPL MEDGUIDE SECTION

300 mg Capsules (Yellow/Yellow colored, size '1' hard gelatin capsules with "104" printed on body of capsules containing white to off white granular powder Bottles of 7 NDC 68071-3230-7

Bottles of 14 NDC 68071-3230-5

Bottles of 30 NDC 68071-3230-3

Bottles of 60 NDC 68071-3230-6

Bottles of 84 NDC 68071-3230-4

Bottles of 90 NDC 68071-3230-9

Bottles of 120 NDC 68071-3230-1

Bottles of 180 NDC 68071-3230-8

Bottles of 270 NDC 68071-3230-2

300mg Gabapentin Capsule Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-3230-12024-07-08C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-22024-07-08C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-32024-07-08C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-42024-07-08C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-52024-07-08C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-62024-07-08C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-72024-07-08C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-82024-07-08C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-92024-07-08C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-12023-01-30C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-22023-01-30C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-32023-01-30C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-42023-01-30C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-52023-01-30C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-62023-01-30C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-72023-01-30C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-82023-01-30C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-92023-01-30C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-12021-02-10C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-22021-02-10C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-32021-02-10C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-42021-02-10C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-52021-02-10C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-62021-02-10C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-72021-02-10C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-82021-02-10C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-92021-02-10C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-12021-01-29C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-22021-01-29C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-32021-01-29C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-42021-01-29C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-52021-01-29C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-62021-01-29C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-72021-01-29C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-82021-01-29C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88
68071-3230-92021-01-29C16284748780-1ba0f9c33-2f9a-a910-e053-dadaa90a0b854fe85b34-8fe8-56fa-e054-00144ff88e88

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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
A090007-001GABAPENTINGABAPENTIN100MGCAPSULE / ORALAB2011-07-21
A090007-002GABAPENTINGABAPENTIN300MGCAPSULE / ORALAB2011-07-21
A090007-003GABAPENTINGABAPENTIN400MGCAPSULE / ORALAB2011-07-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090007-001AB
A090007-002AB
A090007-003AB

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 22:38:342026-08A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-2184e616aacf4f…
2026-09-14 22:38:342026-08A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-2184e616aacf4f…
2026-09-14 22:38:342026-08A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-2184e616aacf4f…
2026-08-18 06:07:402026-07A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-21caaa826d4ba7…
2026-08-18 06:07:402026-07A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-21caaa826d4ba7…
2026-08-18 06:07:402026-07A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-21301d65b070ca…

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 22:38:342026-08A090007-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A090007-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A090007-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A090007-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090007-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090007-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090007-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090007-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090007-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090007-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090007-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090007-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090007-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090007-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090007-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090007-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090007-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090007-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090007-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090007-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090007-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090007-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090007-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090007-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090007-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090007-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090007-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090007-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090007-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090007-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090007-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090007-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090007-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090007-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090007-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090007-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090007-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090007-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090007-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090007-001AB1301d65b070ca…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GABAPENTINGABAPENTINTIME CAP LABORATORIES, INC08880902-bd44-41b6-866b-2cbad4c3f2b12026-07-30Warnings, Adverse reactionsExact identifier
ndc (product): 49483-606
1cc1079f-ef5d-1ba8-e063-6394a90a8e244fe85b34-8fe8-56fa-e054-00144ff88e882024-07-08Exact identifier
spl set id: 4fe85b34-8fe8-56fa-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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