Home NDC 58151-283 Neurontin
Product NDC 58151-283
11-digit product format 581510283
Labeler code 58151
Product ID 58151-283_2d43f32d-2d96-4011-84ac-507c3307dc27
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name gabapentin
Dosage form CAPSULE
Route ORAL
Labeler Viatris Specialty LLC
Application NDA020235
Marketing category NDA
Marketing start 2025-10-01
Substance GABAPENTIN
Active strength 400 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020235-001 NEURONTIN GABAPENTIN 100MG CAPSULE / ORAL AB RLD 1993-12-30 N020235-002 NEURONTIN GABAPENTIN 300MG CAPSULE / ORAL AB RLD 1993-12-30 N020235-003 NEURONTIN GABAPENTIN 400MG CAPSULE / ORAL AB RLD, RS 1993-12-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 129 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N020235-001 NEURONTIN 100MG CAPSULE / ORAL AB RLD 1993-12-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020235-002 NEURONTIN 300MG CAPSULE / ORAL AB RLD 1993-12-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020235-003 NEURONTIN 400MG CAPSULE / ORAL AB RLD, RS 1993-12-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020235-001 NEURONTIN 100MG CAPSULE / ORAL AB RLD 1993-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020235-002 NEURONTIN 300MG CAPSULE / ORAL AB RLD 1993-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020235-003 NEURONTIN 400MG CAPSULE / ORAL AB RLD, RS 1993-12-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020235-001 NEURONTIN 100MG CAPSULE / ORAL AB RLD 1993-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020235-002 NEURONTIN 300MG CAPSULE / ORAL AB RLD 1993-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020235-003 NEURONTIN 400MG CAPSULE / ORAL AB RLD, RS 1993-12-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020235-001 NEURONTIN 100MG CAPSULE / ORAL AB RLD 1993-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020235-002 NEURONTIN 300MG CAPSULE / ORAL AB RLD 1993-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020235-003 NEURONTIN 400MG CAPSULE / ORAL AB RLD, RS 1993-12-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020235-001 NEURONTIN 100MG CAPSULE / ORAL AB RLD 1993-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020235-002 NEURONTIN 300MG CAPSULE / ORAL AB RLD 1993-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020235-003 NEURONTIN 400MG CAPSULE / ORAL AB RLD, RS 1993-12-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020235-001 NEURONTIN 100MG CAPSULE / ORAL AB RLD 1993-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020235-002 NEURONTIN 300MG CAPSULE / ORAL AB RLD 1993-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020235-003 NEURONTIN 400MG CAPSULE / ORAL AB RLD, RS 1993-12-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020235-001 NEURONTIN 100MG CAPSULE / ORAL AB RLD 1993-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020235-002 NEURONTIN 300MG CAPSULE / ORAL AB RLD 1993-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020235-003 NEURONTIN 400MG CAPSULE / ORAL AB RLD, RS 1993-12-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020235-001 NEURONTIN 100MG CAPSULE / ORAL AB RLD 1993-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020235-002 NEURONTIN 300MG CAPSULE / ORAL AB RLD 1993-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020235-003 NEURONTIN 400MG CAPSULE / ORAL AB RLD, RS 1993-12-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020235-001 NEURONTIN 100MG CAPSULE / ORAL AB RLD 1993-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020235-002 NEURONTIN 300MG CAPSULE / ORAL AB RLD 1993-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020235-003 NEURONTIN 400MG CAPSULE / ORAL AB RLD, RS 1993-12-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020235-001 NEURONTIN 100MG CAPSULE / ORAL AB RLD 1993-12-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020235-002 NEURONTIN 300MG CAPSULE / ORAL AB RLD 1993-12-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020235-003 NEURONTIN 400MG CAPSULE / ORAL AB RLD, RS 1993-12-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020235-001 NEURONTIN 100MG CAPSULE / ORAL AB RLD 1993-12-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020235-002 NEURONTIN 300MG CAPSULE / ORAL AB RLD 1993-12-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020235-003 NEURONTIN 400MG CAPSULE / ORAL AB RLD, RS 1993-12-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020235-001 NEURONTIN 100MG CAPSULE / ORAL AB RLD 1993-12-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020235-002 NEURONTIN 300MG CAPSULE / ORAL AB RLD 1993-12-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020235-003 NEURONTIN 400MG CAPSULE / ORAL AB RLD, RS 1993-12-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020235-001 NEURONTIN 100MG CAPSULE / ORAL AB RLD 1993-12-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020235-002 NEURONTIN 300MG CAPSULE / ORAL AB RLD 1993-12-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020235-003 NEURONTIN 400MG CAPSULE / ORAL AB RLD, RS 1993-12-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020235-001 NEURONTIN 100MG CAPSULE / ORAL AB RLD 1993-12-30 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GABAPENTIN 400 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6CW7F3G59X Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 12 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 105028 Internal RxNorm lookup 105029 Internal RxNorm lookup 105030 Internal RxNorm lookup 261280 Internal RxNorm lookup 261281 Internal RxNorm lookup 283523 Internal RxNorm lookup 310430 Internal RxNorm lookup 310431 Internal RxNorm lookup 310432 Internal RxNorm lookup 310433 Internal RxNorm lookup 310434 Internal RxNorm lookup 351973 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58151-283-01 Neurontin 100 in 1 BOTTLE CAPSULE 100 47
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58151-283 NEURONTIN (GABAPENTIN) CAPSULE NEURONTIN (GABAPENTIN) TABLET, FILM COATED NEURONTIN (GABAPENTIN) SOLUTION [VIATRIS SPECIALTY LLC] 41 Current NDC, 1 package rows 20250521_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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 58151-283-01 58151028301 100 CAPSULE in 1 BOTTLE (58151-283-01) 100 capsule 2025-10-01 No No Current