Home NDC 72189-384 Gabapentin
Product NDC 72189-384
11-digit product format 721890384
Labeler code 72189
Product ID 72189-384_2c4cc298-5b75-73fe-e063-6394a90a2ff7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gabapentin
Dosage form CAPSULE
Route ORAL
Labeler Direct_Rx
Application ANDA213603
Marketing category ANDA
Marketing start 2022-09-19
Substance GABAPENTIN
Active strength 100 mg/1
Pharmacologic classes Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 4 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 2025-01-20 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 72189-384-90 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 72189-384-90 0efc9e666f02…f202fb6c5f17…
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 A213603-001 GABAPENTIN GABAPENTIN 100MG CAPSULE / ORAL AB 2020-08-17 A213603-002 GABAPENTIN GABAPENTIN 300MG CAPSULE / ORAL AB 2020-08-17 A213603-003 GABAPENTIN GABAPENTIN 400MG CAPSULE / ORAL AB 2020-08-17
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 3 · 117 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 A213603-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2020-08-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213603-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2020-08-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213603-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2020-08-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213603-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2020-08-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213603-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2020-08-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213603-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2020-08-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213603-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2020-08-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213603-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2020-08-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213603-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2020-08-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213603-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2020-08-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213603-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2020-08-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213603-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2020-08-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213603-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2020-08-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213603-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2020-08-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213603-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2020-08-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213603-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2020-08-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213603-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2020-08-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213603-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2020-08-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213603-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2020-08-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213603-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2020-08-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213603-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2020-08-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213603-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2020-08-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213603-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2020-08-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213603-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2020-08-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213603-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2020-08-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213603-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2020-08-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213603-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2020-08-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213603-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2020-08-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213603-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2020-08-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213603-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2020-08-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213603-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2020-08-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213603-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2020-08-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213603-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2020-08-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213603-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2020-08-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213603-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2020-08-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213603-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2020-08-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213603-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2020-08-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213603-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2020-08-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213603-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2020-08-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213603-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2020-08-17 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 114 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Gabapentin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GABAPENTIN 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6CW7F3G59X Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310430 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72189-384-90 Gabapentin 90 in 1 BOTTLE CAPSULE 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72189-384 GABAPENTIN CAPSULE [DIRECT_RX] 4 Current NDC, Legacy NDC, 1 package rows 20250123_e90d2e3d-ec86-7d1d-e053-2995a90a9167.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72189-384-90 72189038490 90 CAPSULE in 1 BOTTLE (72189-384-90) 90 capsule 2022-09-19 0000-00-00 No No Current