GABAPENTIN

Product NDC
71335-3057
Requested package NDC
71335-3057-2
11-digit product format
713353057
Labeler code
71335
Product ID
71335-3057_6af55316-950c-402a-b479-4fdf6bc662cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA214957
Marketing category
ANDA
Marketing start
2021-10-01
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

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
A214957-001GABAPENTINGABAPENTIN600MGTABLET / ORALAB12021-10-01
A214957-002GABAPENTINGABAPENTIN800MGTABLET / ORALAB12021-10-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214957-001AB1
A214957-002AB1

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 2 · 70 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-0184e616aacf4f…
2026-09-14 22:38:342026-08A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-0184e616aacf4f…
2026-08-18 06:07:402026-07A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-01caaa826d4ba7…
2026-08-18 06:07:402026-07A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-018072bd15b7f6…
2024-05-31 18:47 UTC2024-05A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214957-001GABAPENTIN600MGTABLET / ORALAB2021-10-015c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214957-002GABAPENTIN800MGTABLET / ORALAB2021-10-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214957-001GABAPENTIN600MGTABLET / ORALAB2021-10-015d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A214957-002GABAPENTIN800MGTABLET / ORALAB2021-10-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214957-001GABAPENTIN600MGTABLET / ORALAB2021-10-014b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A214957-002GABAPENTIN800MGTABLET / ORALAB2021-10-014b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214957-001GABAPENTIN600MGTABLET / ORALAB2021-10-01bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A214957-002GABAPENTIN800MGTABLET / ORALAB2021-10-01bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A214957-001AB1184e616aacf4f…
2026-09-14 22:38:342026-08A214957-002AB1184e616aacf4f…
2026-08-18 06:07:402026-07A214957-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A214957-002AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214957-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214957-002AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214957-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214957-002AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214957-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214957-002AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214957-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214957-002AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214957-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214957-002AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214957-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214957-002AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214957-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214957-002AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214957-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214957-002AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214957-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214957-002AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214957-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A214957-002AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214957-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214957-002AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214957-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214957-002AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214957-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214957-002AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214957-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A214957-002AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214957-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214957-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214957-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A214957-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214957-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A214957-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214957-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A214957-002AB1bb7c543d1eb4…

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
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
2e331641-ec26-4d76-b16b-a9863c767afeAvailable 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-3057-1GABAPENTIN30 in 1 BOTTLETABLET301
71335-3057-2GABAPENTIN60 in 1 BOTTLETABLET601
71335-3057-3GABAPENTIN90 in 1 BOTTLETABLET901
71335-3057-4GABAPENTIN180 in 1 BOTTLETABLET1801
71335-3057-5GABAPENTIN120 in 1 BOTTLETABLET1201
71335-3057-6GABAPENTIN100 in 1 BOTTLETABLET1001
71335-3057-7GABAPENTIN84 in 1 BOTTLETABLET841
71335-3057-8GABAPENTIN112 in 1 BOTTLETABLET1121
71335-3057-9GABAPENTIN135 in 1 BOTTLETABLET1351

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-3057-1EA - Each71335-3057bb76fa73-148e-478b-beef-7ad06f98a96412026-03-17
71335-3057-2EA - Each71335-3057c88bd8a4-cfe3-4c76-ae1b-e7d1a07c7d5712026-03-17
71335-3057-3EA - Each71335-3057704ea3b5-95ec-4241-853a-19f886b1053a12026-03-17
71335-3057-4EA - Each71335-305764b160ae-b582-44d6-ba3b-8b4be86852b112026-03-17
71335-3057-5EA - Each71335-3057d1d6ddfe-80f5-424b-a5bc-b105ca6129c212026-03-17
71335-3057-6EA - Each71335-30573175906f-cbc6-4f33-9293-7863e233de0c12026-03-17
71335-3057-7EA - Each71335-3057b291552c-e9b5-4fec-9c8b-952a65b6f43512026-03-17
71335-3057-8EA - Each71335-30571311ad37-cf04-45b5-8135-c2d98566f2a612026-03-17
71335-3057-9EA - Each71335-30577cdb228d-5dbb-40d9-b9f7-8eb158cdb34812026-03-17

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 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GABAPENTINGABAPENTINPHOENIX RX LLC5a85ea98-4211-54eb-e063-6294a90aff332026-09-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINBryant Ranch Prepackc9f0cceb-b24e-4526-b873-fedd877d6bc62026-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINSt. Mary's Medical Park Pharmacy07f07d15-ee91-8c2a-e063-6394a90a46242026-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.180b99a5-7d3d-4ee5-a0cc-1ae0ede646ee2026-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.35da078b-0da0-4757-a6c4-a9144c37e8e12026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.38119f2e-33b3-4c3c-99b7-9335d8d280d42026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINCoupler LLC500ee820-0378-6fc9-e063-6394a90a109c2026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINST. MARY'S MEDICAL PARK PHARMACY4ddc1342-5c83-f562-e063-6294a90a29ba2026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINBryant Ranch Prepack2e331641-ec26-4d76-b16b-a9863c767afe2026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
ndc (package): 71335-3057-2
ndc (product): 71335-3057
ndc11 (package): 71335305702
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.60b46f6d-efbc-487a-b672-b20df8b44cc42026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINProficient Rx LPda8438e1-755b-4195-baa7-464f3d9ee5bd2025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINCamber Pharmaceuticals, Inc.9ead7825-d11b-4e00-8533-328d097b8f832025-08-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINExelan Pharmaceuticals, Inc.a88edb00-2189-4c8d-9dd7-9fe1571775cc2025-08-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINXLCare Pharmaceuticals, Inc.707ed63a-67ca-4a62-9cbe-cdeb5c4ab5062025-08-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GabapentinGABAPENTINDirect_Rxed9c501c-24e4-da89-e053-2a95a90a64c62025-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINProficient Rx LP7fcce531-bf7c-43b6-bea9-8f0602842c532025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINCoupler LLC3133c863-d33b-c9d7-e063-6294a90ae8982025-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINNuCare Pharmaceuticals,Inc.febf610e-e088-4797-e053-6294a90a3eb52025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GabapentinGABAPENTINDirect_Rxfbc05ceb-2e69-3c37-e053-6394a90ac4f42024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINClinical Solutions Wholesale, LLC934fefae-b895-427c-8798-4c5462b1ecc22024-04-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310434gabapentin 800 MG Oral TabletPSN2e331641-ec26-4d76-b16b-a9863c767afe1
310434gabapentin 800 MG Oral TabletSCD2e331641-ec26-4d76-b16b-a9863c767afe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3057-27133530570260 TABLET in 1 BOTTLE (71335-3057-2) 60 tablet2026-02-06NoNoCurrent