Home DailyMed 56456e8f-b5ce-45fa-aa6d-f078bfdc1dfd National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 01:50:12
Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021129-001 NEURONTIN GABAPENTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021129-001 AA
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 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 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021129-001 7256216 2022-05-28 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021129-001 7256216*PED 2022-11-28 Pediatric extension 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021129-001 7256216 2022-05-28 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021129-001 7256216*PED 2022-11-28 Pediatric extension 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021129-001 7256216 2022-05-28 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021129-001 7256216*PED 2022-11-28 Pediatric extension 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021129-001 7256216 2022-05-28 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021129-001 7256216*PED 2022-11-28 Pediatric extension 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021129-001 7256216 2022-05-28 Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021129-001 7256216*PED 2022-11-28 Pediatric extension bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021129-001 7256216 2022-05-28 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021129-001 7256216*PED 2022-11-28 Pediatric extension 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021129-001 7256216 2022-05-28 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021129-001 7256216*PED 2022-11-28 Pediatric extension 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021129-001 7256216 2022-05-28 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021129-001 7256216*PED 2022-11-28 Pediatric extension 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021129-001 7256216 2022-05-28 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021129-001 7256216*PED 2022-11-28 Pediatric extension 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021129-001 7256216 2022-05-28 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021129-001 7256216*PED 2022-11-28 Pediatric extension c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021129-001 7256216 2022-05-28 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021129-001 7256216*PED 2022-11-28 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021129-001 7256216 2022-05-28 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021129-001 7256216*PED 2022-11-28 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021129-001 7256216 2022-05-28 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021129-001 7256216*PED 2022-11-28 Pediatric extension ea99ee380514…2023-01-26 05:58 UTC 2023-01 N021129-001 7256216 2022-05-28 Drug product 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N021129-001 7256216*PED 2022-11-28 Pediatric extension 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021129-001 7256216 2022-05-28 Drug product 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021129-001 7256216*PED 2022-11-28 Pediatric extension 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021129-001 7256216 2022-05-28 Drug product f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N021129-001 7256216*PED 2022-11-28 Pediatric extension f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021129-001 7256216 2022-05-28 Drug product e64feba35796…2022-09-29 23:25 UTC 2022-09 N021129-001 7256216*PED 2022-11-28 Pediatric extension e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021129-001 7256216 2022-05-28 Drug product cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021129-001 7256216*PED 2022-11-28 Pediatric extension cb3db0bc1861…
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 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.