Home NDC 43353-872-45 GABAPENTIN
Product NDC 43353-872
Requested package NDC 43353-872-45
11-digit product format 433530872
Labeler code 43353
Product ID 43353-872_17454231-0b63-4a89-92cb-1c6737ff4f5e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name gabapentin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA202764
Marketing category ANDA
Marketing start 2012-11-02
Marketing end 0000-00-00
Substance GABAPENTIN
Active strength 600 mg/1
Pharmacologic classes Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 2022-12-31
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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 A202764-001 GABAPENTIN GABAPENTIN 600MG TABLET / ORAL 2012-10-16 A202764-002 GABAPENTIN GABAPENTIN 800MG TABLET / ORAL 2012-10-16
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 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202764-001 GABAPENTIN 600MG TABLET / ORAL AB 2012-10-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202764-002 GABAPENTIN 800MG TABLET / ORAL AB 2012-10-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202764-001 GABAPENTIN 600MG TABLET / ORAL AB 2012-10-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202764-002 GABAPENTIN 800MG TABLET / ORAL AB 2012-10-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202764-001 GABAPENTIN 600MG TABLET / ORAL AB 2012-10-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202764-002 GABAPENTIN 800MG TABLET / ORAL AB 2012-10-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202764-001 GABAPENTIN 600MG TABLET / ORAL AB 2012-10-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202764-002 GABAPENTIN 800MG TABLET / ORAL AB 2012-10-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202764-001 GABAPENTIN 600MG TABLET / ORAL AB 2012-10-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A202764-002 GABAPENTIN 800MG TABLET / ORAL AB 2012-10-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202764-001 GABAPENTIN 600MG TABLET / ORAL AB 2012-10-16 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A202764-002 GABAPENTIN 800MG TABLET / ORAL AB 2012-10-16 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 52 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Related label table NDC Related label 43353-872-30 These highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP. GABAPENTIN Tablets, USP for Oral Use, Initial U.S. Approval: 1993 43353-872-45 These highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP. GABAPENTIN Tablets, USP for Oral Use, Initial U.S. Approval: 1993 43353-872-53 These highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP. GABAPENTIN Tablets, USP for Oral Use, Initial U.S. Approval: 1993 43353-872-60 These highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP. GABAPENTIN Tablets, USP for Oral Use, Initial U.S. Approval: 1993 43353-872-70 These highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP. GABAPENTIN Tablets, USP for Oral Use, Initial U.S. Approval: 1993 43353-872-73 These highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP. GABAPENTIN Tablets, USP for Oral Use, Initial U.S. Approval: 1993 43353-872-80 These highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP. GABAPENTIN Tablets, USP for Oral Use, Initial U.S. Approval: 1993 43353-872-92 These highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP. GABAPENTIN Tablets, USP for Oral Use, Initial U.S. Approval: 1993
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43353-872-30 GABAPENTIN 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 4 43353-872-45 GABAPENTIN 45 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 45 4 43353-872-53 GABAPENTIN 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 4 43353-872-60 GABAPENTIN 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 4 43353-872-70 GABAPENTIN 120 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 120 4 43353-872-73 GABAPENTIN 135 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 135 4 43353-872-80 GABAPENTIN 180 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 180 4 43353-872-92 GABAPENTIN 270 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 270 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Gabapentin ACTIVE INGREDIENT 6CW7F3G59X GABAPENTIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Gabapentin ACTIVE MOIETY 6CW7F3G59X GABAPENTIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Crospovidone INACTIVE INGREDIENT 68401960MK GABAPENTIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Hydroxypropyl Cellulose INACTIVE INGREDIENT RFW2ET671P GABAPENTIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Hypromellose 2910 (3 mpa.s) INACTIVE INGREDIENT 0VUT3PMY82 GABAPENTIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 GABAPENTIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Mannitol INACTIVE INGREDIENT 3OWL53L36A GABAPENTIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Polyethylene Glycols INACTIVE INGREDIENT 3WJQ0SDW1A GABAPENTIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H GABAPENTIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Talc INACTIVE INGREDIENT 7SEV7J4R1U GABAPENTIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP GABAPENTIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-872 GABAPENTIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 4 Legacy NDC, 8 package rows 20210316_95b96f56-ca06-4715-bcc0-6dd4399e7a6c.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 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 43353-872-45 43353087245 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-872-45) 2013-11-13 0000-00-00 No No Current