Home NDC 43353-863 Gabapentin
Product NDC 43353-863
11-digit product format 433530863
Labeler code 43353
Product ID 43353-863_19801231-00a9-4772-b3b1-9be1ac7c1b86
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gabapentin
Dosage form CAPSULE
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA078787
Marketing category ANDA
Marketing start 2008-01-31
Marketing end 0000-00-00
Substance GABAPENTIN
Active strength 300 mg/1
Pharmacologic classes Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 18 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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GABAPENTIN ACTIVE INGREDIENT 6CW7F3G59X GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 GABAPENTIN ACTIVE MOIETY 6CW7F3G59X GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-863 GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 Legacy NDC 20171029_f041f43e-dbd8-4cbf-ad77-f0d9c6b8ffa8.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 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 43353-863-30 43353086330 30 CAPSULE in 1 BOTTLE, PLASTIC (43353-863-30) 30 capsule 2013-12-26 0000-00-00 No No Current 43353-863-53 43353086353 60 CAPSULE in 1 BOTTLE, PLASTIC (43353-863-53) 60 capsule 2014-07-01 0000-00-00 No No Current 43353-863-60 43353086360 90 CAPSULE in 1 BOTTLE, PLASTIC (43353-863-60) 90 capsule 2015-03-06 0000-00-00 No No Current 43353-863-70 43353086370 120 CAPSULE in 1 BOTTLE, PLASTIC (43353-863-70) 120 capsule 2013-08-16 0000-00-00 No No Current 43353-863-80 43353086380 180 CAPSULE in 1 BOTTLE, PLASTIC (43353-863-80) 180 capsule 2014-07-01 0000-00-00 No No Current 43353-863-92 43353086392 270 CAPSULE in 1 BOTTLE, PLASTIC (43353-863-92) 270 capsule 2015-03-27 0000-00-00 No No Current 43353-863-94 43353086394 360 CAPSULE in 1 BOTTLE, PLASTIC (43353-863-94) 360 capsule 2013-08-23 0000-00-00 No No Current 43353-863-98 43353086398 540 CAPSULE in 1 BOTTLE, PLASTIC (43353-863-98) 540 capsule 2013-08-23 0000-00-00 No No Current