Gabapentin

Product NDC
71093-112
11-digit product format
710930112
Labeler code
71093
Product ID
71093-112_c5f1ec3b-405e-4128-882b-43559d5083e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ACI Healthcare USA, Inc.
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
d7646d5e-ca25-4ec5-9e4b-931edcb15a0eAvailable 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
71093-112-04Gabapentin100 in 1 BOTTLETABLET, FILM COATED10017
71093-112-05Gabapentin500 in 1 BOTTLETABLET, FILM COATED50017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71093-112-04EA - Each71093-112cce35ccf-60b6-4a3b-a93e-75307f6ef78312017-07-07
71093-112-05EA - Each71093-112094e08bc-edc2-4b72-95d6-1000ce7fc09112017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71093-112GABAPENTIN TABLET, FILM COATED [ACI HEALTHCARE USA, INC.]17Current NDC, Legacy NDC, 2 package rows20231218_d7646d5e-ca25-4ec5-9e4b-931edcb15a0e.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
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
ndc (product): 71093-112
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 TabletPSN56967a93-b3c0-4043-9241-585fc64e2624101
310434gabapentin 800 MG Oral TabletSCD56967a93-b3c0-4043-9241-585fc64e2624101
310433gabapentin 600 MG Oral TabletPSNd7646d5e-ca25-4ec5-9e4b-931edcb15a0e17
310434gabapentin 800 MG Oral TabletPSNd7646d5e-ca25-4ec5-9e4b-931edcb15a0e17
310433gabapentin 600 MG Oral TabletSCDd7646d5e-ca25-4ec5-9e4b-931edcb15a0e17
310434gabapentin 800 MG Oral TabletSCDd7646d5e-ca25-4ec5-9e4b-931edcb15a0e17
310430gabapentin 100 MG Oral CapsulePSNa7e45e3f-e382-32ba-e053-2a95a90a253715
310432gabapentin 400 MG Oral CapsulePSNa7e45e3f-e382-32ba-e053-2a95a90a253715
310434gabapentin 800 MG Oral TabletPSNa7e45e3f-e382-32ba-e053-2a95a90a253715
310430gabapentin 100 MG Oral CapsuleSCDa7e45e3f-e382-32ba-e053-2a95a90a253715
310432gabapentin 400 MG Oral CapsuleSCDa7e45e3f-e382-32ba-e053-2a95a90a253715
310434gabapentin 800 MG Oral TabletSCDa7e45e3f-e382-32ba-e053-2a95a90a253715
310434gabapentin 800 MG Oral TabletPSN47f2a06f-4eac-4dca-aa2a-a36dd4daaea07
310434gabapentin 800 MG Oral TabletSCD47f2a06f-4eac-4dca-aa2a-a36dd4daaea07
310434gabapentin 800 MG Oral TabletPSNb4954172-5439-48fd-8348-8a2e0d2fee625
310434gabapentin 800 MG Oral TabletSCDb4954172-5439-48fd-8348-8a2e0d2fee625
310434gabapentin 800 MG Oral TabletPSNc09c66fd-cb31-41dd-b00b-acc58bd809f73
310434gabapentin 800 MG Oral TabletSCDc09c66fd-cb31-41dd-b00b-acc58bd809f73
310434gabapentin 800 MG Oral TabletPSNb6db5ce9-bd4b-420d-88a7-df9d46144c812
310434gabapentin 800 MG Oral TabletSCDb6db5ce9-bd4b-420d-88a7-df9d46144c812
310433gabapentin 600 MG Oral TabletPSNa8539169-25fc-79e7-e053-2995a90a69251
310434gabapentin 800 MG Oral TabletPSNba2a8352-5776-4edb-914e-ce1d18ccda321
310434gabapentin 800 MG Oral TabletPSNa8539169-25fc-79e7-e053-2995a90a69251
310434gabapentin 800 MG Oral TabletPSN9af351e3-1a98-7523-e053-2a95a90a9ca91
310433gabapentin 600 MG Oral TabletSCDa8539169-25fc-79e7-e053-2995a90a69251
310434gabapentin 800 MG Oral TabletSCDa8539169-25fc-79e7-e053-2995a90a69251
310434gabapentin 800 MG Oral TabletSCDba2a8352-5776-4edb-914e-ce1d18ccda321
310434gabapentin 800 MG Oral TabletSCD9af351e3-1a98-7523-e053-2a95a90a9ca91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71093-112-0471093011204100 TABLET, FILM COATED in 1 BOTTLE (71093-112-04) 2014-01-110000-00-00NoNoCurrent
71093-112-0571093011205500 TABLET, FILM COATED in 1 BOTTLE (71093-112-05) 2014-01-110000-00-00NoNoCurrent