Neurontin

Product NDC
58151-290
11-digit product format
581510290
Labeler code
58151
Product ID
58151-290_2d43f32d-2d96-4011-84ac-507c3307dc27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin
Dosage form
SOLUTION
Route
ORAL
Labeler
Viatris Specialty LLC
Application
NDA021129
Marketing category
NDA
Marketing start
2026-01-14
Marketing end
2027-05-31
Substance
GABAPENTIN
Active strength
250 mg/5mL
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021129-001NEURONTINGABAPENTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021129-001AA

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-0284e616aacf4f…
2026-08-18 06:07:402026-07N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-0287673890dc5c…
2021-03-12 10:30 UTC2021-03N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-023f01610625f2…
2019-09-15 20:21 UTC2019-09N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02b00525d2431f…
2019-07-19 19:46 UTC2019-07N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-023f0d92c62455…
2023-05-13 08:27 UTC2023-05N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02053a50430f4f…
2023-01-26 05:58 UTC2023-01N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021129-001NEURONTIN250MG/5MLSOLUTION / ORALAARLD, RS2000-03-02f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-09-29 23:25 UTC2022-09N021129-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021129-001AA1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021129-001AA1a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021129-00172562162022-05-28Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021129-0017256216*PED2022-11-28Pediatric extension5c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021129-00172562162022-05-28Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021129-0017256216*PED2022-11-28Pediatric extension5d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021129-00172562162022-05-28Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021129-0017256216*PED2022-11-28Pediatric extension4b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021129-00172562162022-05-28Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021129-0017256216*PED2022-11-28Pediatric extension74a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021129-00172562162022-05-28Drug productbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021129-0017256216*PED2022-11-28Pediatric extensionbb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021129-00172562162022-05-28Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N021129-0017256216*PED2022-11-28Pediatric extension782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021129-00172562162022-05-28Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021129-0017256216*PED2022-11-28Pediatric extension87673890dc5c…
2021-03-12 10:30 UTC2021-03N021129-00172562162022-05-28Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021129-0017256216*PED2022-11-28Pediatric extension5aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021129-00172562162022-05-28Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021129-0017256216*PED2022-11-28Pediatric extension8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021129-00172562162022-05-28Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021129-0017256216*PED2022-11-28Pediatric extensionc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021129-00172562162022-05-28Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021129-0017256216*PED2022-11-28Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N021129-00172562162022-05-28Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021129-0017256216*PED2022-11-28Pediatric extensionb00525d2431f…
2019-07-19 19:46 UTC2019-07N021129-00172562162022-05-28Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021129-0017256216*PED2022-11-28Pediatric extensionea99ee380514…
2023-01-26 05:58 UTC2023-01N021129-00172562162022-05-28Drug product3bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N021129-0017256216*PED2022-11-28Pediatric extension3bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021129-00172562162022-05-28Drug product3a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021129-0017256216*PED2022-11-28Pediatric extension3a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021129-00172562162022-05-28Drug productf41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N021129-0017256216*PED2022-11-28Pediatric extensionf41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021129-00172562162022-05-28Drug producte64feba35796…
2022-09-29 23:25 UTC2022-09N021129-0017256216*PED2022-11-28Pediatric extensione64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021129-00172562162022-05-28Drug productcb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021129-0017256216*PED2022-11-28Pediatric extensioncb3db0bc1861…

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
Neurontin

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN250 mg/5mL

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 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
105028Internal RxNorm lookup
105029Internal RxNorm lookup
105030Internal RxNorm lookup
261280Internal RxNorm lookup
261281Internal RxNorm lookup
283523Internal RxNorm lookup
310430Internal RxNorm lookup
310431Internal RxNorm lookup
310432Internal RxNorm lookup
310433Internal RxNorm lookup
310434Internal RxNorm lookup
351973Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
97935fd9-1d4a-43b6-a5d9-de994591187bAvailable 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
58151-290-35Neurontin1 in 1 CARTONSOLUTION147
58151-290-35Neurontin470 mL in 1 BOTTLESOLUTION47047

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58151-290-35ML - Milliliter58151-290a3e8840b-5328-4ecf-abf2-465a8025259412026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58151-290NEURONTIN (GABAPENTIN) CAPSULE NEURONTIN (GABAPENTIN) TABLET, FILM COATED NEURONTIN (GABAPENTIN) SOLUTION [VIATRIS SPECIALTY LLC]41Current NDC, 2 package rows20250521_97935fd9-1d4a-43b6-a5d9-de994591187b.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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NeurontinGABAPENTINViatris Specialty LLC97935fd9-1d4a-43b6-a5d9-de994591187b2026-05-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 021129
application number: NDA021129
ndc (product): 58151-290
GABAPENTINGABAPENTINMylan Pharmaceuticals Inc.cff7de45-148b-4e96-88fd-6052bf75b5f72025-04-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 021129
application number: NDA021129
NeurontinGABAPENTINParke-Davis Div of Pfizer Incee9ad9ed-6d9f-4ee1-9d7f-cfad438df3882022-07-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 021129
application number: NDA021129

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN97935fd9-1d4a-43b6-a5d9-de994591187b47
283523gabapentin 250 MG in 5 mL Oral SolutionPSN97935fd9-1d4a-43b6-a5d9-de994591187b47
310431gabapentin 300 MG Oral CapsulePSN97935fd9-1d4a-43b6-a5d9-de994591187b47
310432gabapentin 400 MG Oral CapsulePSN97935fd9-1d4a-43b6-a5d9-de994591187b47
310433gabapentin 600 MG Oral TabletPSN97935fd9-1d4a-43b6-a5d9-de994591187b47
310434gabapentin 800 MG Oral TabletPSN97935fd9-1d4a-43b6-a5d9-de994591187b47
105028Neurontin 100 MG Oral CapsulePSN97935fd9-1d4a-43b6-a5d9-de994591187b47
351973Neurontin 250 MG in 5 mL Oral SolutionPSN97935fd9-1d4a-43b6-a5d9-de994591187b47
105029Neurontin 300 MG Oral CapsulePSN97935fd9-1d4a-43b6-a5d9-de994591187b47
105030Neurontin 400 MG Oral CapsulePSN97935fd9-1d4a-43b6-a5d9-de994591187b47
261280Neurontin 600 MG Oral TabletPSN97935fd9-1d4a-43b6-a5d9-de994591187b47
261281Neurontin 800 MG Oral TabletPSN97935fd9-1d4a-43b6-a5d9-de994591187b47
105028gabapentin 100 MG Oral Capsule [Neurontin]SBD97935fd9-1d4a-43b6-a5d9-de994591187b47
105029gabapentin 300 MG Oral Capsule [Neurontin]SBD97935fd9-1d4a-43b6-a5d9-de994591187b47
105030gabapentin 400 MG Oral Capsule [Neurontin]SBD97935fd9-1d4a-43b6-a5d9-de994591187b47
351973gabapentin 50 MG/ML Oral Solution [Neurontin]SBD97935fd9-1d4a-43b6-a5d9-de994591187b47
261280gabapentin 600 MG Oral Tablet [Neurontin]SBD97935fd9-1d4a-43b6-a5d9-de994591187b47
261281gabapentin 800 MG Oral Tablet [Neurontin]SBD97935fd9-1d4a-43b6-a5d9-de994591187b47
310430gabapentin 100 MG Oral CapsuleSCD97935fd9-1d4a-43b6-a5d9-de994591187b47
310431gabapentin 300 MG Oral CapsuleSCD97935fd9-1d4a-43b6-a5d9-de994591187b47
310432gabapentin 400 MG Oral CapsuleSCD97935fd9-1d4a-43b6-a5d9-de994591187b47
283523gabapentin 50 MG/ML Oral SolutionSCD97935fd9-1d4a-43b6-a5d9-de994591187b47
310433gabapentin 600 MG Oral TabletSCD97935fd9-1d4a-43b6-a5d9-de994591187b47
310434gabapentin 800 MG Oral TabletSCD97935fd9-1d4a-43b6-a5d9-de994591187b47
283523gabapentin 250 MG per 5 ML Oral SolutionSY97935fd9-1d4a-43b6-a5d9-de994591187b47
283523gabapentin 300 MG per 6 ML Oral SolutionSY97935fd9-1d4a-43b6-a5d9-de994591187b47
283523gabapentin 500 MG per 10 ML Oral SolutionSY97935fd9-1d4a-43b6-a5d9-de994591187b47
105028Neurontin 100 MG Oral CapsuleSY97935fd9-1d4a-43b6-a5d9-de994591187b47
351973Neurontin 250 MG per 5 ML Oral SolutionSY97935fd9-1d4a-43b6-a5d9-de994591187b47
105029Neurontin 300 MG Oral CapsuleSY97935fd9-1d4a-43b6-a5d9-de994591187b47
105030Neurontin 400 MG Oral CapsuleSY97935fd9-1d4a-43b6-a5d9-de994591187b47
351973Neurontin 50 MG/ML Oral SolutionSY97935fd9-1d4a-43b6-a5d9-de994591187b47
261280Neurontin 600 MG Oral TabletSY97935fd9-1d4a-43b6-a5d9-de994591187b47
261281Neurontin 800 MG Oral TabletSY97935fd9-1d4a-43b6-a5d9-de994591187b47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58151-290-35581510290351 BOTTLE in 1 CARTON (58151-290-35) / 470 mL in 1 BOTTLE1 bottle2026-01-142027-05-31NoNoHistorical