Home Applications 020882 Application 020882
Type NDA
Sponsor PFIZER PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NEURONTIN GABAPENTIN TABLET;ORAL 600MG Yes No 002 NEURONTIN GABAPENTIN TABLET;ORAL 800MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020882-001 NEURONTIN GABAPENTIN 600MG TABLET / ORAL AB1 RLD 1998-10-09 N020882-002 NEURONTIN GABAPENTIN 800MG TABLET / ORAL AB1 RLD, RS 1998-10-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 82 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 2026-02-19 14:30 UTC 2026-02 N020882-001 NEURONTIN 600MG TABLET / ORAL AB1 RLD 1998-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020882-002 NEURONTIN 800MG TABLET / ORAL AB1 RLD, RS 1998-10-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020882-001 NEURONTIN 600MG TABLET / ORAL AB1 RLD 1998-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020882-002 NEURONTIN 800MG TABLET / ORAL AB1 RLD, RS 1998-10-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020882-001 NEURONTIN 600MG TABLET / ORAL AB1 RLD 1998-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020882-002 NEURONTIN 800MG TABLET / ORAL AB1 RLD, RS 1998-10-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020882-001 NEURONTIN 600MG TABLET / ORAL AB1 RLD 1998-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020882-002 NEURONTIN 800MG TABLET / ORAL AB1 RLD, RS 1998-10-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020882-001 NEURONTIN 600MG TABLET / ORAL AB1 RLD 1998-10-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020882-002 NEURONTIN 800MG TABLET / ORAL AB1 RLD, RS 1998-10-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020882-001 NEURONTIN 600MG TABLET / ORAL AB1 RLD 1998-10-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020882-002 NEURONTIN 800MG TABLET / ORAL AB1 RLD, RS 1998-10-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020882-001 NEURONTIN 600MG TABLET / ORAL AB1 RLD 1998-10-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020882-002 NEURONTIN 800MG TABLET / ORAL AB1 RLD, RS 1998-10-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020882-001 NEURONTIN 600MG TABLET / ORAL AB1 RLD 1998-10-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020882-002 NEURONTIN 800MG TABLET / ORAL AB1 RLD, RS 1998-10-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020882-001 NEURONTIN 600MG TABLET / ORAL AB1 RLD 1998-10-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020882-002 NEURONTIN 800MG TABLET / ORAL AB1 RLD, RS 1998-10-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020882-001 NEURONTIN 600MG TABLET / ORAL AB1 RLD 1998-10-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020882-002 NEURONTIN 800MG TABLET / ORAL AB1 RLD, RS 1998-10-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020882-001 NEURONTIN 600MG TABLET / ORAL AB1 RLD 1998-10-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020882-002 NEURONTIN 800MG TABLET / ORAL AB1 RLD, RS 1998-10-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020882-001 NEURONTIN 600MG TABLET / ORAL AB1 RLD 1998-10-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020882-002 NEURONTIN 800MG TABLET / ORAL AB1 RLD, RS 1998-10-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020882-001 NEURONTIN 600MG TABLET / ORAL AB1 RLD 1998-10-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020882-002 NEURONTIN 800MG TABLET / ORAL AB1 RLD, RS 1998-10-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020882-001 NEURONTIN 600MG TABLET / ORAL AB1 RLD 1998-10-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020882-002 NEURONTIN 800MG TABLET / ORAL AB1 RLD, RS 1998-10-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020882-001 NEURONTIN 600MG TABLET / ORAL AB RLD 1998-10-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020882-002 NEURONTIN 800MG TABLET / ORAL AB RLD, RS 1998-10-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020882-001 NEURONTIN 600MG TABLET / ORAL AB RLD 1998-10-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020882-002 NEURONTIN 800MG TABLET / ORAL AB RLD, RS 1998-10-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020882-001 NEURONTIN 600MG TABLET / ORAL AB RLD 1998-10-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020882-002 NEURONTIN 800MG TABLET / ORAL AB RLD, RS 1998-10-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020882-001 NEURONTIN 600MG TABLET / ORAL AB RLD 1998-10-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020882-002 NEURONTIN 800MG TABLET / ORAL AB RLD, RS 1998-10-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020882-001 NEURONTIN 600MG TABLET / ORAL AB RLD 1998-10-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020882-002 NEURONTIN 800MG TABLET / ORAL AB RLD, RS 1998-10-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020882-001 NEURONTIN 600MG TABLET / ORAL AB RLD 1998-10-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020882-002 NEURONTIN 800MG TABLET / ORAL AB RLD, RS 1998-10-09 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 24 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0071-0401 Neurontin gabapentin Parke-Davis Div of Pfizer Inc NDA Current 0071-0401 Neurontin gabapentin Parke-Davis Div of Pfizer Inc NDA Current 0071-0401 Neurontin gabapentin Parke-Davis Div of Pfizer NDA Current 0071-0401 Neurontin gabapentin Parke-Davis Div of Pfizer Inc NDA Current 0071-0401 Neurontin gabapentin Parke-Davis Div of Pfizer Inc NDA Current 0071-0401 Neurontin gabapentin Parke-Davis Div of Pfizer Inc NDA Current 0071-0401 Neurontin gabapentin Parke-Davis Div of Pfizer Inc NDA Current 0071-0513 Neurontin gabapentin Parke-Davis Div of Pfizer Inc NDA Current 0071-0513 Neurontin gabapentin Parke-Davis Div of Pfizer Inc NDA Current 0071-0513 Neurontin gabapentin Parke-Davis Div of Pfizer NDA Current 0071-0513 Neurontin gabapentin Parke-Davis Div of Pfizer Inc NDA Current 0071-0513 Neurontin gabapentin Parke-Davis Div of Pfizer Inc NDA Current 0071-0513 Neurontin gabapentin Parke-Davis Div of Pfizer Inc NDA Current 0071-0513 Neurontin gabapentin Parke-Davis Div of Pfizer Inc NDA Current 59762-4355 GABAPENTIN gabapentin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-4355 GABAPENTIN gabapentin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-4355 GABAPENTIN gabapentin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-4355 GABAPENTIN gabapentin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-4355 GABAPENTIN gabapentin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-4460 GABAPENTIN gabapentin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-4460 GABAPENTIN gabapentin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-4460 GABAPENTIN gabapentin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-4460 GABAPENTIN gabapentin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-4460 GABAPENTIN gabapentin Greenstone LLC NDA AUTHORIZED GENERIC Current