Home NDC 64380-868 GABAPENTIN
Product NDC 64380-868
11-digit product format 643800868
Labeler code 64380
Product ID 64380-868_1a530f38-ba87-4707-8d04-16be59ae34a6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name gabapentin
Dosage form CAPSULE
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA211314
Marketing category ANDA
Marketing start 2018-10-17
Substance GABAPENTIN
Active strength 300 mg/1
Pharmacologic classes Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A211314-001 GABAPENTIN GABAPENTIN 100MG CAPSULE / ORAL AB 2018-10-16 A211314-002 GABAPENTIN GABAPENTIN 300MG CAPSULE / ORAL AB 2018-10-16 A211314-003 GABAPENTIN GABAPENTIN 400MG CAPSULE / ORAL AB 2018-10-16
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 · 123 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 A211314-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211314-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211314-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211314-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211314-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211314-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211314-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211314-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211314-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211314-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211314-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211314-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211314-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211314-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211314-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211314-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211314-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211314-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211314-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211314-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211314-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-10-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211314-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-10-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211314-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-10-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211314-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-10-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211314-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-10-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211314-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-10-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211314-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-10-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211314-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-10-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211314-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-10-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211314-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-10-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211314-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-10-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211314-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-10-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211314-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-10-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211314-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-10-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211314-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-10-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211314-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-10-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211314-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-10-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211314-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-10-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211314-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-10-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211314-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-10-16 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base GABAPENTIN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GABAPENTIN 300 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310430 Internal RxNorm lookup 310431 Internal RxNorm lookup 310432 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 64380-868-06 GABAPENTIN 100 in 1 BOTTLE CAPSULE 100 10 64380-868-07 GABAPENTIN 500 in 1 BOTTLE CAPSULE 500 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64380-868 GABAPENTIN CAPSULE [STRIDES PHARMA SCIENCE LIMITED] 7 Current NDC, Legacy NDC, 2 package rows 20250129_43b67ae3-ac6f-48f5-8788-9ead08376864.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 64380-868-06 64380086806 100 CAPSULE in 1 BOTTLE (64380-868-06) 100 capsule 2018-10-17 0000-00-00 No No Current 64380-868-07 64380086807 500 CAPSULE in 1 BOTTLE (64380-868-07) 500 capsule 2018-10-17 0000-00-00 No No Current