Home NDC 0615-8232 Gabapentin
Product NDC 0615-8232
11-digit product format 006158232
Labeler code 0615
Product ID 0615-8232_aa7f8790-8a5d-482c-acb2-5e44a1e8174c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gabapentin
Dosage form CAPSULE
Route ORAL
Labeler NCS HealthCare of KY, Inc dba Vangard Labs
Application ANDA078787
Marketing category ANDA
Marketing start 2008-01-31
Marketing end 2022-03-31
Substance GABAPENTIN
Active strength 400 mg/1
Pharmacologic classes Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A078787-001 GABAPENTIN GABAPENTIN 100MG CAPSULE / ORAL AB 2008-01-31 A078787-002 GABAPENTIN GABAPENTIN 300MG CAPSULE / ORAL AB 2008-01-31 A078787-003 GABAPENTIN GABAPENTIN 400MG CAPSULE / ORAL AB 2008-01-31
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 A078787-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2008-01-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078787-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2008-01-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078787-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2008-01-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078787-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2008-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078787-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2008-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078787-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2008-01-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078787-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2008-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078787-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2008-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078787-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2008-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078787-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2008-01-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078787-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2008-01-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078787-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2008-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078787-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2008-01-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078787-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2008-01-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078787-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2008-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078787-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2008-01-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078787-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2008-01-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078787-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2008-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078787-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2008-01-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078787-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2008-01-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078787-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2008-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078787-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2008-01-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078787-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2008-01-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078787-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2008-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078787-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2008-01-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078787-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2008-01-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078787-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2008-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078787-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2008-01-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078787-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2008-01-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078787-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2008-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078787-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2008-01-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078787-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2008-01-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078787-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2008-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078787-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2008-01-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078787-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2008-01-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078787-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2008-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078787-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2008-01-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078787-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2008-01-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078787-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2008-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078787-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2008-01-31 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.
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 2 of 2 · 21 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Gabapentin GABAPENTIN Aphena Pharma Solutions - Tennessee, LLC 5fbd601f-df95-4a79-a7d3-c3505e23b913 2018-09-06 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0615-8232-30 00615823230 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8232-30) > 5 CAPSULE in 1 BLISTER PACK 6 blister pack 2019-06-18 2022-03-31 No No Current 0615-8232-39 00615823239 30 CAPSULE in 1 BLISTER PACK (0615-8232-39) 30 capsule 2019-06-25 2022-03-31 No No Current