Home NDC 48433-307 Gabapentin
Product NDC 48433-307
11-digit product format 484330307
Labeler code 48433
Product ID 48433-307_0c27d406-45de-4df0-8db0-c3d654fe7637
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gabapentin
Dosage form CAPSULE
Route ORAL
Labeler Safecor Health, LLC
Application ANDA078787
Marketing category ANDA
Marketing start 2014-09-30
Marketing end 0000-00-00
Substance GABAPENTIN
Active strength 100 mg/1
Pharmacologic classes Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 2019-12-31
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 48433-307-10 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 48433-307-10 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 48433-307-10 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 48433-307-10 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 48433-307-10 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 48433-307-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 48433-307-10 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 48433-307-10 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 48433-307-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 48433-307-10 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 48433-307-10 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 48433-307-10 557ba5c1ecfa…9c80585c8c6e…
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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GABAPENTIN ACTIVE INGREDIENT 6CW7F3G59X GABAPENTIN CAPSULE [SAFECOR HEALTH, LLC] 1 GABAPENTIN ACTIVE MOIETY 6CW7F3G59X GABAPENTIN CAPSULE [SAFECOR HEALTH, LLC] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 GABAPENTIN CAPSULE [SAFECOR HEALTH, LLC] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT GABAPENTIN CAPSULE [SAFECOR HEALTH, LLC] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 GABAPENTIN CAPSULE [SAFECOR HEALTH, LLC] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L GABAPENTIN CAPSULE [SAFECOR HEALTH, LLC] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O GABAPENTIN CAPSULE [SAFECOR HEALTH, LLC] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J GABAPENTIN CAPSULE [SAFECOR HEALTH, LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ GABAPENTIN CAPSULE [SAFECOR HEALTH, LLC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U GABAPENTIN CAPSULE [SAFECOR HEALTH, LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP GABAPENTIN CAPSULE [SAFECOR HEALTH, LLC] 1
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