Gabapentin

Product NDC
58657-720
11-digit product format
586570720
Labeler code
58657
Product ID
58657-720_edb5dd4a-354d-fb9c-e053-2995a90acb47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Method Pharmaceuticals, LLC
Application
ANDA207099
Marketing category
ANDA
Marketing start
2017-03-24
Marketing end
2022-12-31
Substance
GABAPENTIN
Active strength
100 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct58657-720DDiscontinued by firm2026-08-11
excluded packagepackage58657-72058657-720-01DDiscontinued by firm2026-08-11
excluded packagepackage58657-72058657-720-10DDiscontinued by firm2026-08-11
excluded packagepackage58657-72058657-720-50DDiscontinued by firm2026-08-11

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 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage58657-720-50d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage58657-720-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage58657-720-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage58657-720-50f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage58657-720-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage58657-720-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage58657-720-502ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage58657-720-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage58657-720-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage58657-720-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage58657-720-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage58657-720-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage58657-720-50cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage58657-720-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage58657-720-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage58657-720-50cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage58657-720-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage58657-720-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage58657-720-50302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage58657-720-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage58657-720-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage58657-720-50ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage58657-720-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage58657-720-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58657-720-500efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58657-720-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58657-720-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage58657-720-50ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage58657-720-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage58657-720-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage58657-720-50367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage58657-720-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage58657-720-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage58657-720-50557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage58657-720-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage58657-720-10557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A207099-001GABAPENTINGABAPENTIN100MGCAPSULE / ORALAB2017-03-24
A207099-002GABAPENTINGABAPENTIN300MGCAPSULE / ORALAB2017-03-24
A207099-003GABAPENTINGABAPENTIN400MGCAPSULE / ORALAB2017-03-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207099-001AB
A207099-002AB
A207099-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207099-001GABAPENTIN100MGCAPSULE / ORALAB2017-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207099-002GABAPENTIN300MGCAPSULE / ORALAB2017-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207099-003GABAPENTIN400MGCAPSULE / ORALAB2017-03-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207099-001GABAPENTIN100MGCAPSULE / ORALAB2017-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207099-002GABAPENTIN300MGCAPSULE / ORALAB2017-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207099-003GABAPENTIN400MGCAPSULE / ORALAB2017-03-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A207099-001GABAPENTIN100MGCAPSULE / ORALAB2017-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207099-002GABAPENTIN300MGCAPSULE / ORALAB2017-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207099-003GABAPENTIN400MGCAPSULE / ORALAB2017-03-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207099-001GABAPENTIN100MGCAPSULE / ORALAB2017-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207099-002GABAPENTIN300MGCAPSULE / ORALAB2017-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207099-003GABAPENTIN400MGCAPSULE / ORALAB2017-03-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207099-001GABAPENTIN100MGCAPSULE / ORALAB2017-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207099-002GABAPENTIN300MGCAPSULE / ORALAB2017-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207099-003GABAPENTIN400MGCAPSULE / ORALAB2017-03-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207099-001GABAPENTIN100MGCAPSULE / ORALAB2017-03-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207099-002GABAPENTIN300MGCAPSULE / ORALAB2017-03-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207099-003GABAPENTIN400MGCAPSULE / ORALAB2017-03-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207099-001GABAPENTIN100MGCAPSULE / ORALAB2017-03-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207099-002GABAPENTIN300MGCAPSULE / ORALAB2017-03-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207099-003GABAPENTIN400MGCAPSULE / ORALAB2017-03-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207099-001GABAPENTIN100MGCAPSULE / ORALAB2017-03-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207099-002GABAPENTIN300MGCAPSULE / ORALAB2017-03-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207099-003GABAPENTIN400MGCAPSULE / ORALAB2017-03-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207099-001GABAPENTIN100MGCAPSULE / ORALAB2017-03-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207099-002GABAPENTIN300MGCAPSULE / ORALAB2017-03-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207099-003GABAPENTIN400MGCAPSULE / ORALAB2017-03-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207099-001GABAPENTIN100MGCAPSULE / ORALAB2017-03-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A207099-002GABAPENTIN300MGCAPSULE / ORALAB2017-03-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A207099-003GABAPENTIN400MGCAPSULE / ORALAB2017-03-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207099-001GABAPENTIN100MGCAPSULE / ORALAB2017-03-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207099-002GABAPENTIN300MGCAPSULE / ORALAB2017-03-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207099-003GABAPENTIN400MGCAPSULE / ORALAB2017-03-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207099-001GABAPENTIN100MGCAPSULE / ORALAB2017-03-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207099-002GABAPENTIN300MGCAPSULE / ORALAB2017-03-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207099-003GABAPENTIN400MGCAPSULE / ORALAB2017-03-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207099-001GABAPENTIN100MGCAPSULE / ORALAB2017-03-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207099-002GABAPENTIN300MGCAPSULE / ORALAB2017-03-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207099-003GABAPENTIN400MGCAPSULE / ORALAB2017-03-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207099-001GABAPENTIN100MGCAPSULE / ORALAB2017-03-248072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207099-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207099-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207099-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207099-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207099-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207099-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207099-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207099-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207099-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207099-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207099-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207099-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207099-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207099-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207099-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207099-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207099-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207099-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207099-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207099-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207099-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207099-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207099-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207099-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207099-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207099-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207099-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207099-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207099-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207099-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207099-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207099-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207099-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207099-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207099-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207099-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207099-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207099-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207099-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207099-001AB18072bd15b7f6…

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
gabapentinGABAPENTINREMEDYREPACK INC.32169228-e85c-4dbf-8722-cd2f8e0f5d1a2026-07-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207099
application number: ANDA207099
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacy2bc65375-77b8-1e50-e063-6294a90acf8f2026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207099
application number: ANDA207099
gabapentinGABAPENTINProficient Rx LPc7674ea5-276b-4bb3-821b-4ac05c9e64e62026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207099
application number: ANDA207099
GabapentinGABAPENTINDirect_Rx0b286fd1-8179-d87a-e063-6294a90a2f232026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207099
application number: ANDA207099
gabapentinGABAPENTINCoupler LLC47cd25f6-e123-9aaf-e063-6394a90aeedd2026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207099
application number: ANDA207099
gabapentinGABAPENTINNorthwind Health Company, LLC471b2d32-0cbd-aade-e063-6394a90a16962025-12-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207099
application number: ANDA207099
gabapentinGABAPENTINREMEDYREPACK INC.4a975ebe-ae0a-446a-8a3d-2ca325e28f932025-09-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207099
application number: ANDA207099
gabapentinGABAPENTINCoupler LLC3eeda97d-c3cd-65cd-e063-6394a90aae8b2025-09-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207099
application number: ANDA207099
GabapentinGABAPENTINDirect_Rx2cb1ad6d-d389-4564-e063-6394a90a36442025-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207099
application number: ANDA207099
gabapentinGABAPENTINRising Pharma Holdings, Inc.969cccfc-e56a-49da-9d36-47c0c3fad7f82025-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207099
application number: ANDA207099
GabapentinGABAPENTINProficient Rx LP64a65366-8577-48f2-9f8e-0332f126d3c12025-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207099
application number: ANDA207099
GabapentinGABAPENTINEpic Pharma, LLC030e656a-e384-49ac-830f-32140c18112d2019-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207099
application number: ANDA207099

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58657-720-0158657072001100 CAPSULE in 1 BOTTLE (58657-720-01) 100 capsule2017-03-240000-00-00NoNoCurrent
58657-720-10586570720101000 CAPSULE in 1 BOTTLE (58657-720-10) 1000 capsule2017-03-240000-00-00NoNoCurrent
58657-720-5058657072050500 CAPSULE in 1 BOTTLE (58657-720-50) 500 capsule2017-03-240000-00-00NoNoCurrent