Gabapentin

Product NDC
76420-497
Requested package NDC
76420-497-12
11-digit product format
764200497
Labeler code
76420
Product ID
76420-497_eaa81374-5d2c-60d1-e053-2a95a90af8ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA205101
Marketing category
ANDA
Marketing start
2016-02-04
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-0484e616aacf4f…
2026-09-14 22:38:342026-08A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-0484e616aacf4f…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A205101-001AB1184e616aacf4f…
2026-09-14 22:38:342026-08A205101-002AB1184e616aacf4f…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 · 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
9d544944-ea95-42e1-8c65-9e442437f0eeAvailable 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
76420-497-01Gabapentin100 in 1 BOTTLETABLET1001
76420-497-05Gabapentin500 in 1 BOTTLETABLET5001
76420-497-12Gabapentin120 in 1 BOTTLETABLET1201
76420-497-24Gabapentin240 in 1 BOTTLETABLET2401
76420-497-30Gabapentin30 in 1 BOTTLETABLET301
76420-497-60Gabapentin60 in 1 BOTTLETABLET601
76420-497-90Gabapentin90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-497-01EA - Each76420-49791f06a4b-dcd7-4e72-ae97-76162d69299712022-11-07
76420-497-05EA - Each76420-497eddd8bdd-b112-4baf-a640-7940804fafa312022-11-07
76420-497-12EA - Each76420-4979f05a985-2994-49e9-880c-e44610a87f6612022-11-07
76420-497-24EA - Each76420-49751198138-bf89-4c57-89f4-c48d0a038ca512022-11-07
76420-497-30EA - Each76420-49734742be7-30ed-42f0-b0be-46557c3d608a12022-11-07
76420-497-60EA - Each76420-4976f64bee2-c051-4703-8823-c17691bcae9312022-11-07
76420-497-90EA - Each76420-497a0a10d60-300f-4af7-b8cf-8141879228f512022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-497GABAPENTIN TABLET [ASCLEMED USA, INC.]1Current NDC, Legacy NDC, 7 package rows20221012_9d544944-ea95-42e1-8c65-9e442437f0ee.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 TabletPSN9d544944-ea95-42e1-8c65-9e442437f0ee1
310434gabapentin 800 MG Oral TabletSCD9d544944-ea95-42e1-8c65-9e442437f0ee1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-497-1276420049712120 TABLET in 1 BOTTLE (76420-497-12) 120 tablet2022-10-100000-00-00NoNoCurrent