Gabapentin

Product NDC
70518-2323
11-digit product format
705182323
Labeler code
70518
Product ID
70518-2323_4ddb2ddc-40fa-1869-e063-6294a90a3f78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA200651
Marketing category
ANDA
Marketing start
2019-09-24
Substance
GABAPENTIN
Active strength
800 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

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 packagepackage70518-232370518-2323-2DDiscontinued by firm2026-08-07

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
A200651-001GABAPENTINGABAPENTIN600MGTABLET / ORALAB12011-10-06
A200651-002GABAPENTINGABAPENTIN800MGTABLET / ORALAB12011-10-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A200651-001AB1
A200651-002AB1

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 UTC2026-02A200651-001GABAPENTIN600MGTABLET / ORALAB12011-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200651-002GABAPENTIN800MGTABLET / ORALAB12011-10-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200651-001GABAPENTIN600MGTABLET / ORALAB12011-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200651-002GABAPENTIN800MGTABLET / ORALAB12011-10-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A200651-001GABAPENTIN600MGTABLET / ORALAB12011-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200651-002GABAPENTIN800MGTABLET / ORALAB12011-10-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200651-001GABAPENTIN600MGTABLET / ORALAB12011-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200651-002GABAPENTIN800MGTABLET / ORALAB12011-10-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200651-001GABAPENTIN600MGTABLET / ORALAB12011-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200651-002GABAPENTIN800MGTABLET / ORALAB12011-10-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200651-001GABAPENTIN600MGTABLET / ORALAB12011-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200651-002GABAPENTIN800MGTABLET / ORALAB12011-10-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200651-001GABAPENTIN600MGTABLET / ORALAB12011-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200651-002GABAPENTIN800MGTABLET / ORALAB12011-10-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200651-001GABAPENTIN600MGTABLET / ORALAB12011-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200651-002GABAPENTIN800MGTABLET / ORALAB12011-10-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200651-001GABAPENTIN600MGTABLET / ORALAB12011-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200651-002GABAPENTIN800MGTABLET / ORALAB12011-10-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200651-001GABAPENTIN600MGTABLET / ORALAB12011-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A200651-002GABAPENTIN800MGTABLET / ORALAB12011-10-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200651-001GABAPENTIN600MGTABLET / ORALAB12011-10-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200651-002GABAPENTIN800MGTABLET / ORALAB12011-10-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200651-001GABAPENTIN600MGTABLET / ORALAB12011-10-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200651-002GABAPENTIN800MGTABLET / ORALAB12011-10-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200651-001GABAPENTIN600MGTABLET / ORALAB12011-10-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200651-002GABAPENTIN800MGTABLET / ORALAB12011-10-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200651-001GABAPENTIN600MGTABLET / ORALAB12011-10-068072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200651-002GABAPENTIN800MGTABLET / ORALAB12011-10-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200651-001GABAPENTIN600MGTABLET / ORALAB2011-10-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200651-002GABAPENTIN800MGTABLET / ORALAB2011-10-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200651-001GABAPENTIN600MGTABLET / ORALAB2011-10-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200651-002GABAPENTIN800MGTABLET / ORALAB2011-10-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200651-001GABAPENTIN600MGTABLET / ORALAB2011-10-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200651-002GABAPENTIN800MGTABLET / ORALAB2011-10-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200651-001GABAPENTIN600MGTABLET / ORALAB2011-10-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200651-002GABAPENTIN800MGTABLET / ORALAB2011-10-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200651-001GABAPENTIN600MGTABLET / ORALAB2011-10-06bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200651-002GABAPENTIN800MGTABLET / ORALAB2011-10-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200651-001GABAPENTIN600MGTABLET / ORALAB2011-10-06782e0a99824c…
2021-12-28 21:50 UTC2021-12A200651-002GABAPENTIN800MGTABLET / ORALAB2011-10-06782e0a99824c…

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 UTC2026-02A200651-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200651-002AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200651-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200651-002AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200651-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200651-002AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200651-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200651-002AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200651-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200651-002AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200651-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200651-002AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200651-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200651-002AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200651-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200651-002AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200651-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200651-002AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200651-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A200651-002AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200651-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200651-002AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200651-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200651-002AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200651-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200651-002AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200651-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200651-002AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200651-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200651-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200651-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200651-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200651-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200651-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200651-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200651-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200651-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200651-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200651-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A200651-002AB1782e0a99824c…

Additional Listing Data#

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

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
429a1bb5-babf-4f36-8264-46d71164f1c0Available 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
70518-2323-0Gabapentin30 in 1 BLISTER PACKTABLET, FILM COATED3014
70518-2323-1Gabapentin90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9014
70518-2323-2Gabapentin180 in 1 BOTTLE, PLASTICTABLET, FILM COATED18014
70518-2323-3Gabapentin120 in 1 BOTTLE, PLASTICTABLET, FILM COATED12014
70518-2323-4Gabapentin100 in 1 BOXTABLET, FILM COATED10014
70518-2323-5Gabapentin1 in 1 POUCHTABLET, FILM COATED114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2323-1EA - Each70518-232361a3c50d-6021-430a-b8cf-e41ad9655ed512025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2323GABAPENTIN TABLET, FILM COATED [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 6 package rows20250312_429a1bb5-babf-4f36-8264-46d71164f1c0.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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINREMEDYREPACK INC.5a78ab50-993d-4857-be10-be665e02b3532026-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
GabapentinGABAPENTINREMEDYREPACK INC.429a1bb5-babf-4f36-8264-46d71164f1c02026-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
ndc (product): 70518-2323
GabapentinGABAPENTINREMEDYREPACK INC.7ddc7d92-9076-41cf-97ed-d9f9edc802982026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
GabapentinGABAPENTINCardinal Health 107, LLCb2da7d96-73ad-4f44-8784-160a384a09612026-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
GabapentinGABAPENTINMajor Pharmaceuticals152adf1d-ec0c-4561-bf80-e4c7da1587232026-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
GabapentinGABAPENTINA-S Medication Solutions0e1d17d5-d39c-4144-aac0-7c0d3bc9ec0d2026-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
GabapentinGABAPENTINA-S Medication Solutions2343e3a1-82d0-4c70-a086-a01a0ce81ef32026-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
GabapentinGABAPENTINBryant Ranch Prepackd9d78138-e1e9-4107-9099-4910cb1422d82025-10-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
GabapentinGABAPENTINBryant Ranch Prepackbe9a572d-e98a-41c1-83c5-859d9176dd1c2025-10-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
GabapentinGABAPENTINBryant Ranch Prepack8f982b95-4e84-4e0c-a543-747bc3dd75312025-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
GabapentinGABAPENTINBryant Ranch Prepackd0510d04-460c-47d1-be72-0ee32c4ac6402025-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
GabapentinGABAPENTINNorthStar Rx LLC9508cb1b-3f9f-48bd-8f34-a6fbb68c9a4a2025-07-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
GabapentinGABAPENTINQUALLENT PHARMACEUTICALS HEALTH LLC472bb279-bb4e-4246-b2a3-172483ba356b2025-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
GabapentinGABAPENTINAurobindo Pharma Limited25cf6c40-a239-4dd0-9cad-28da84d285db2025-05-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
GABAPENTINGABAPENTINDIRECT RXa5b47f89-ed35-31de-e053-2a95a90a55542025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCafa28969-91c8-83fd-e053-2a95a90a656b2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCb37b1dcc-c7e9-8845-e053-2995a90a089e2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
GabapentinGABAPENTINAdvanced Rx Pharmacy of Tennessee, LLCc898711b-9a65-1816-e053-2995a90a855e2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
GabapentinGABAPENTINProficient Rx LPc79d94ec-117d-4fb6-845d-1954e3472bb02021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310434gabapentin 800 MG Oral TabletPSN429a1bb5-babf-4f36-8264-46d71164f1c014
310434gabapentin 800 MG Oral TabletSCD429a1bb5-babf-4f36-8264-46d71164f1c014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2323-07051823230030 TABLET, FILM COATED in 1 BLISTER PACK (70518-2323-0) 2019-09-240000-00-00NoNoCurrent
70518-2323-17051823230190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2323-1) 2019-10-040000-00-00NoNoCurrent
70518-2323-270518232302180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2323-2) 2019-10-090000-00-00NoNoCurrent
70518-2323-370518232303120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2323-3) 2020-12-230000-00-00NoNoCurrent
70518-2323-470518232304100 POUCH in 1 BOX (70518-2323-4) / 1 TABLET, FILM COATED in 1 POUCH (70518-2323-5) 100 pouch2026-03-24NoNoCurrent
70518-2323-5705182323051 in 1 POUCHHistorical