Gabapentin

Product NDC
71335-1007
11-digit product format
713351007
Labeler code
71335
Product ID
71335-1007_b749e1c1-83fc-4693-99e8-1341909d80f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203244
Marketing category
ANDA
Marketing start
2014-01-11
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
A203244-001GABAPENTINGABAPENTIN800MGTABLET / ORALAB12013-07-12
A203244-002GABAPENTINGABAPENTIN600MGTABLET / ORALAB12013-07-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203244-001AB1
A203244-002AB1

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203244-001GABAPENTIN800MGTABLET / ORALAB2013-07-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203244-002GABAPENTIN600MGTABLET / ORALAB2013-07-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203244-001GABAPENTIN800MGTABLET / ORALAB2013-07-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203244-002GABAPENTIN600MGTABLET / ORALAB2013-07-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203244-001GABAPENTIN800MGTABLET / ORALAB2013-07-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203244-002GABAPENTIN600MGTABLET / ORALAB2013-07-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203244-001GABAPENTIN800MGTABLET / ORALAB2013-07-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203244-002GABAPENTIN600MGTABLET / ORALAB2013-07-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203244-001GABAPENTIN800MGTABLET / ORALAB2013-07-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203244-002GABAPENTIN600MGTABLET / ORALAB2013-07-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203244-001GABAPENTIN800MGTABLET / ORALAB2013-07-12782e0a99824c…
2021-12-28 21:50 UTC2021-12A203244-002GABAPENTIN600MGTABLET / ORALAB2013-07-12782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203244-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203244-002AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203244-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203244-002AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203244-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203244-002AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203244-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203244-002AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203244-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203244-002AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203244-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203244-002AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203244-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203244-002AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203244-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203244-002AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203244-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203244-002AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203244-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A203244-002AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203244-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203244-002AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203244-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203244-002AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203244-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203244-002AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203244-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203244-002AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203244-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203244-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203244-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203244-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203244-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203244-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203244-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203244-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203244-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203244-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203244-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203244-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Gabapentin
Listing expiration
2026-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
47f2a06f-4eac-4dca-aa2a-a36dd4daaea0Available 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1007-1Gabapentin30 in 1 BOTTLETABLET, FILM COATED307
71335-1007-2Gabapentin60 in 1 BOTTLETABLET, FILM COATED607
71335-1007-3Gabapentin90 in 1 BOTTLETABLET, FILM COATED907
71335-1007-4Gabapentin180 in 1 BOTTLETABLET, FILM COATED1807
71335-1007-5Gabapentin120 in 1 BOTTLETABLET, FILM COATED1207
71335-1007-6Gabapentin100 in 1 BOTTLETABLET, FILM COATED1007
71335-1007-7Gabapentin84 in 1 BOTTLETABLET, FILM COATED847
71335-1007-8Gabapentin112 in 1 BOTTLETABLET, FILM COATED1127
71335-1007-9Gabapentin135 in 1 BOTTLETABLET, FILM COATED1357

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1007-1EA - Each71335-1007f2b25697-1f03-47d4-94fe-7a0995686db512021-07-15
71335-1007-2EA - Each71335-1007b791aa29-3ce5-4638-b5e7-da655acfdcb712021-07-15
71335-1007-3EA - Each71335-100752c93a4e-79e2-4248-9daf-9bd9eada669012019-09-05
71335-1007-5EA - Each71335-10079f3e7833-80d9-47e1-a2f1-b44d11da9d7012019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1007GABAPENTIN TABLET, FILM COATED [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 9 package rows20240410_47f2a06f-4eac-4dca-aa2a-a36dd4daaea0.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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINREMEDYREPACK INC.07c8bb17-9bd4-4fab-994d-0412205b53b42026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINBryant Ranch Prepackb6db5ce9-bd4b-420d-88a7-df9d46144c812026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINStrides Pharma Science Limitedbec31452-b52b-4698-ba4c-0b614780ee842025-11-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacy7d3fc163-25f0-2c61-e053-2991aa0a76e92025-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GABAPENTINGABAPENTINDIRECT RXa7e45e3f-e382-32ba-e053-2a95a90a25372025-01-17Exact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINBryant Ranch Prepack6e6b9d8f-9f9e-4760-96ea-fb8b0a3bbbdb2024-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINBryant Ranch Prepack47f2a06f-4eac-4dca-aa2a-a36dd4daaea02024-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
ndc (product): 71335-1007
GabapentinGABAPENTINBryant Ranch Prepackb4954172-5439-48fd-8348-8a2e0d2fee622024-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINBryant Ranch Prepackc9944562-563a-423d-972c-f0313375d2342024-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINBryant Ranch Prepack56967a93-b3c0-4043-9241-585fc64e26242023-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINBryant Ranch Prepack0eb27e64-1488-4083-82c7-cebb8c0605de2023-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINACI Healthcare USA, Inc.d7646d5e-ca25-4ec5-9e4b-931edcb15a0e2023-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC39149f0e-30ed-4671-8be7-2a484f65d63b2020-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINProficient Rx LP8b2f38ef-0a0c-45cc-88ca-cc086bf806412020-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLCba2a8352-5776-4edb-914e-ce1d18ccda322020-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINProficient Rx LPc09c66fd-cb31-41dd-b00b-acc58bd809f72020-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310434gabapentin 800 MG Oral TabletPSN47f2a06f-4eac-4dca-aa2a-a36dd4daaea07
310434gabapentin 800 MG Oral TabletSCD47f2a06f-4eac-4dca-aa2a-a36dd4daaea07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1007-17133510070130 TABLET, FILM COATED in 1 BOTTLE (71335-1007-1) 2019-08-010000-00-00NoNoCurrent
71335-1007-27133510070260 TABLET, FILM COATED in 1 BOTTLE (71335-1007-2) 2018-11-140000-00-00NoNoCurrent
71335-1007-37133510070390 TABLET, FILM COATED in 1 BOTTLE (71335-1007-3) 2018-11-140000-00-00NoNoCurrent
71335-1007-471335100704180 TABLET, FILM COATED in 1 BOTTLE (71335-1007-4) 2024-04-090000-00-00NoNoCurrent
71335-1007-571335100705120 TABLET, FILM COATED in 1 BOTTLE (71335-1007-5) 2019-01-280000-00-00NoNoCurrent
71335-1007-671335100706100 TABLET, FILM COATED in 1 BOTTLE (71335-1007-6) 2024-04-090000-00-00NoNoCurrent
71335-1007-77133510070784 TABLET, FILM COATED in 1 BOTTLE (71335-1007-7) 2024-04-090000-00-00NoNoCurrent
71335-1007-871335100708112 TABLET, FILM COATED in 1 BOTTLE (71335-1007-8) 2024-04-090000-00-00NoNoCurrent
71335-1007-971335100709135 TABLET, FILM COATED in 1 BOTTLE (71335-1007-9) 2024-04-090000-00-00NoNoCurrent