GABAPENTIN

Product NDC
76282-706
11-digit product format
762820706
Labeler code
76282
Product ID
76282-706_96999ce4-193e-4817-939c-900ab87fc88f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Exelan Pharmaceuticals, Inc.
Application
ANDA214957
Marketing category
ANDA
Marketing start
2021-10-01
Substance
GABAPENTIN
Active strength
600 mg/1
Pharmacologic classes
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 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
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 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A214957-001GABAPENTIN600MGTABLET / 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…
2021-12-28 21:50 UTC2021-12A214957-001GABAPENTIN600MGTABLET / ORALAB2021-10-01782e0a99824c…
2021-12-28 21:50 UTC2021-12A214957-002GABAPENTIN800MGTABLET / ORALAB2021-10-01782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2021-12-28 21:50 UTC2021-12A214957-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A214957-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
GABAPENTIN
Listing expiration
2026-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310433Internal RxNorm lookup
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
a88edb00-2189-4c8d-9dd7-9fe1571775ccAvailable 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
76282-706-05GABAPENTIN500 in 1 BOTTLETABLET5003
76282-706-90GABAPENTIN90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-706-05EA - Each76282-70611f86ecc-365e-4c24-beba-0585fa3ebe0612021-12-08
76282-706-90EA - Each76282-706cb9c7983-dcde-4abd-ad41-02934a9937c812021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-706GABAPENTIN TABLET [EXELAN PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20211125_a88edb00-2189-4c8d-9dd7-9fe1571775cc.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 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
ndc (product): 76282-706
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
GABAPENTINGABAPENTINAsclemed USA, Inc.1f1203f4-2184-4e13-e063-6394a90a43302025-05-21Warnings, 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
310433gabapentin 600 MG Oral TabletPSNa88edb00-2189-4c8d-9dd7-9fe1571775cc3
310434gabapentin 800 MG Oral TabletPSNa88edb00-2189-4c8d-9dd7-9fe1571775cc3
310433gabapentin 600 MG Oral TabletSCDa88edb00-2189-4c8d-9dd7-9fe1571775cc3
310434gabapentin 800 MG Oral TabletSCDa88edb00-2189-4c8d-9dd7-9fe1571775cc3
310433gabapentin 600 MG Oral TabletPSN7f579665-afb7-4227-98c1-2eafee6505042
310433gabapentin 600 MG Oral TabletSCD7f579665-afb7-4227-98c1-2eafee6505042
310433gabapentin 600 MG Oral TabletPSN2658e3d6-653c-8eb8-e063-6394a90a479a1
310433gabapentin 600 MG Oral TabletSCD2658e3d6-653c-8eb8-e063-6394a90a479a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-706-0576282070605500 TABLET in 1 BOTTLE (76282-706-05) 500 tablet2021-10-010000-00-00NoNoCurrent
76282-706-907628207069090 TABLET in 1 BOTTLE (76282-706-90) 90 tablet2021-10-010000-00-00NoNoCurrent