Gabapentin

Product NDC
50090-5045
Requested package NDC
50090-5045-1
11-digit product format
500905045
Labeler code
50090
Product ID
50090-5045_a42502f6-622a-4f0d-bff9-bc4e4ba63c18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA205101
Marketing category
ANDA
Marketing start
2016-02-04
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
800 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-504550090-5045-1IInactivated by FDA2026-08-17

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 · 15 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…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A205101-001GABAPENTINGABAPENTIN600MGTABLET / ORALAB12016-02-04
A205101-002GABAPENTINGABAPENTIN800MGTABLET / ORALAB12016-02-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205101-001AB1
A205101-002AB1

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-04caaa826d4ba7…
2026-08-18 06:07:402026-07A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205101-001GABAPENTIN600MGTABLET / ORALAB2016-02-045c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205101-002GABAPENTIN800MGTABLET / ORALAB2016-02-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205101-001GABAPENTIN600MGTABLET / ORALAB2016-02-045d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205101-002GABAPENTIN800MGTABLET / ORALAB2016-02-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205101-001GABAPENTIN600MGTABLET / ORALAB2016-02-044b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205101-002GABAPENTIN800MGTABLET / ORALAB2016-02-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205101-001GABAPENTIN600MGTABLET / ORALAB2016-02-0474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205101-002GABAPENTIN800MGTABLET / ORALAB2016-02-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205101-001GABAPENTIN600MGTABLET / ORALAB2016-02-04bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205101-002GABAPENTIN800MGTABLET / ORALAB2016-02-04bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A205101-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A205101-002AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205101-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205101-002AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205101-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205101-002AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205101-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205101-002AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205101-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205101-002AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205101-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205101-002AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205101-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205101-002AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205101-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205101-002AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205101-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205101-002AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205101-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205101-002AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205101-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A205101-002AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205101-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205101-002AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205101-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205101-002AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205101-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205101-002AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205101-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205101-002AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205101-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205101-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205101-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205101-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205101-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205101-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205101-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205101-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205101-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205101-002AB1bb7c543d1eb4…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5045-0Gabapentin60 in 1 BOTTLETABLET603
50090-5045-1Gabapentin90 in 1 BOTTLETABLET903
50090-5045-2Gabapentin30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5045GABAPENTIN TABLET [A-S MEDICATION SOLUTIONS]3Legacy NDC, 3 package rows20210417_f1bce199-9f88-4a94-9006-8e148dedd45f.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 2 · 31 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINPD-Rx Pharmaceuticals, Inc.9b175f8d-7667-4bfe-8bb5-fd7441eed4562026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINHAWAII REPACK, INC.f6ff265b-569b-4f5c-8fdb-00b7ad4aac7c2026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacyba4d863d-be38-8cf5-e053-2995a90a69fb2026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacyc85ae572-9893-629e-e053-2995a90a23fc2026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINBryant Ranch Prepackce0f0d7f-da6d-47da-a4ed-fb8f729024122026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINBryant Ranch Prepackabb56036-88df-4720-ba78-5299716715452026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINBryant Ranch Prepacka75c9157-a1fc-44cc-89f8-c5a3742fb9ed2026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINBryant Ranch Prepackd1aa4690-57b5-4a3e-ac12-85f777dbd05e2026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINBryant Ranch Prepack75caca13-1432-4c0d-8d45-f029b0b2d4172026-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINBryant Ranch Prepack56378630-e7a7-4981-8212-8ea703a433d82026-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINRadha Pharmaceuticals, Inc.1045db4e-4c76-4a0d-bf12-019bd96a8f592026-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINScieGen Pharmaceuticals, Inc.5ab9c18b-9568-4dcb-90b0-252aef8f8dc22026-02-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINPreferred Pharmaceuticals, Inc.5d3f27bf-3486-40fa-a4d3-5f0b2c6c01512025-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINPreferred Pharmaceuticals, Inc.561f53d5-5301-42b3-b372-f3d49d642a2e2025-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINCoupler LLC3133fc78-dd7a-880c-e063-6394a90a89e12025-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINDirectrxd5c9dd2c-b8ee-1406-e053-2995a90a02872025-01-21Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GABAPENTINGABAPENTINDIRECT RXa7e45e3f-e382-32ba-e053-2a95a90a25372025-01-17Exact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINCreekwood Pharmaceuticals LLC266ef369-0a56-f225-e063-6294a90a495e2024-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.a9c99dfa-f54d-9207-e053-2995a90ad43b2024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.a9f0852e-0c58-ba22-e053-2995a90adfa02024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310434gabapentin 800 MG Oral TabletPSNf1bce199-9f88-4a94-9006-8e148dedd45f3
310434gabapentin 800 MG Oral TabletSCDf1bce199-9f88-4a94-9006-8e148dedd45f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5045-15009050450190 TABLET in 1 BOTTLE (50090-5045-1) 90 tablet2020-05-130000-00-00NoNoCurrent