Gabapentin

Product NDC
70518-2616
Requested package NDC
70518-2616-0
11-digit product format
705182616
Labeler code
70518
Product ID
70518-2616_4a7a5fa7-ae72-42cf-e063-6394a90a90ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA200651
Marketing category
ANDA
Marketing start
2020-03-09
Substance
GABAPENTIN
Active strength
600 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

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 · 11 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…

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
GABAPENTIN600 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
310433Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7ddc7d92-9076-41cf-97ed-d9f9edc80298Available 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
70518-2616-0Gabapentin30 in 1 BLISTER PACKTABLET, FILM COATED3017
70518-2616-1Gabapentin90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9017
70518-2616-2Gabapentin28 in 1 BLISTER PACKTABLET, FILM COATED2817
70518-2616-3Gabapentin30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3017
70518-2616-4Gabapentin100 in 1 BOXTABLET, FILM COATED10017
70518-2616-5Gabapentin1 in 1 POUCHTABLET, FILM COATED117
70518-2616-6Gabapentin60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6017

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
GabapentinGABAPENTINREMEDYREPACK INC.7ddc7d92-9076-41cf-97ed-d9f9edc802982026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
ndc (package): 70518-2616-0
ndc (product): 70518-2616
ndc11 (package): 70518261600
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
310433gabapentin 600 MG Oral TabletPSN7ddc7d92-9076-41cf-97ed-d9f9edc8029817
310433gabapentin 600 MG Oral TabletSCD7ddc7d92-9076-41cf-97ed-d9f9edc8029817

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2616-07051826160030 TABLET, FILM COATED in 1 BLISTER PACK (70518-2616-0) 2020-03-090000-00-00NoNoCurrent