Home NDC 68382-608-16 gabapentin
Product NDC 68382-608
Requested package NDC 68382-608-16
11-digit product format 683820608
Labeler code 68382
Product ID 68382-608_898c1710-d86c-4fbe-9a53-34661fcdb63a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name gabapentin
Dosage form TABLET
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA203934
Marketing category ANDA
Marketing start 2024-01-25
Substance GABAPENTIN
Active strength 300 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203934-001 GABAPENTIN GABAPENTIN 300MG TABLET / ORAL AB2 2024-01-24 A203934-002 GABAPENTIN GABAPENTIN 600MG TABLET / ORAL AB2 2024-01-24 A203934-003 GABAPENTIN GABAPENTIN 450MG TABLET / ORAL AB 2025-08-25 A203934-004 GABAPENTIN GABAPENTIN 750MG TABLET / ORAL AB 2025-08-25 A203934-005 GABAPENTIN GABAPENTIN 900MG TABLET / ORAL AB 2025-08-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 2 · 53 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 A203934-001 GABAPENTIN 300MG TABLET / ORAL AB2 2024-01-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203934-002 GABAPENTIN 600MG TABLET / ORAL AB2 2024-01-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203934-003 GABAPENTIN 450MG TABLET / ORAL AB 2025-08-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203934-004 GABAPENTIN 750MG TABLET / ORAL AB 2025-08-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203934-005 GABAPENTIN 900MG TABLET / ORAL AB 2025-08-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203934-001 GABAPENTIN 300MG TABLET / ORAL AB2 2024-01-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203934-002 GABAPENTIN 600MG TABLET / ORAL AB2 2024-01-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203934-003 GABAPENTIN 450MG TABLET / ORAL AB 2025-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203934-004 GABAPENTIN 750MG TABLET / ORAL AB 2025-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203934-005 GABAPENTIN 900MG TABLET / ORAL AB 2025-08-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203934-001 GABAPENTIN 300MG TABLET / ORAL AB2 2024-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203934-002 GABAPENTIN 600MG TABLET / ORAL AB2 2024-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203934-003 GABAPENTIN 450MG TABLET / ORAL AB 2025-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203934-004 GABAPENTIN 750MG TABLET / ORAL AB 2025-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203934-005 GABAPENTIN 900MG TABLET / ORAL AB 2025-08-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203934-001 GABAPENTIN 300MG TABLET / ORAL AB2 2024-01-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203934-002 GABAPENTIN 600MG TABLET / ORAL AB2 2024-01-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203934-003 GABAPENTIN 450MG TABLET / ORAL AB 2025-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203934-004 GABAPENTIN 750MG TABLET / ORAL AB 2025-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203934-005 GABAPENTIN 900MG TABLET / ORAL AB 2025-08-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203934-001 GABAPENTIN 300MG TABLET / ORAL AB2 2024-01-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203934-002 GABAPENTIN 600MG TABLET / ORAL AB2 2024-01-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203934-001 GABAPENTIN 300MG TABLET / ORAL AB2 2024-01-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203934-002 GABAPENTIN 600MG TABLET / ORAL AB2 2024-01-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203934-001 GABAPENTIN 300MG TABLET / ORAL AB2 2024-01-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203934-002 GABAPENTIN 600MG TABLET / ORAL AB2 2024-01-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203934-001 GABAPENTIN 300MG TABLET / ORAL AB2 2024-01-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203934-002 GABAPENTIN 600MG TABLET / ORAL AB2 2024-01-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203934-001 GABAPENTIN 300MG TABLET / ORAL AB2 2024-01-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203934-002 GABAPENTIN 600MG TABLET / ORAL AB2 2024-01-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203934-001 GABAPENTIN 300MG TABLET / ORAL AB2 2024-01-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203934-002 GABAPENTIN 600MG TABLET / ORAL AB2 2024-01-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203934-001 GABAPENTIN 300MG TABLET / ORAL AB2 2024-01-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203934-002 GABAPENTIN 600MG TABLET / ORAL AB2 2024-01-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203934-001 GABAPENTIN 300MG TABLET / ORAL AB2 2024-01-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203934-002 GABAPENTIN 600MG TABLET / ORAL AB2 2024-01-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203934-001 GABAPENTIN 300MG TABLET / ORAL AB2 2024-01-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203934-002 GABAPENTIN 600MG TABLET / ORAL AB2 2024-01-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203934-001 GABAPENTIN 300MG TABLET / ORAL AB2 2024-01-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203934-002 GABAPENTIN 600MG TABLET / ORAL AB2 2024-01-24 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 53 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 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 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1806380 Internal RxNorm lookup 1806382 Internal RxNorm lookup 2634743 Internal RxNorm lookup 2634747 Internal RxNorm lookup 2634751 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 68382-608-05 gabapentin 500 in 1 BOTTLE TABLET 500 3 68382-608-16 gabapentin 90 in 1 BOTTLE TABLET 90 3 68382-608-30 gabapentin 10 in 1 BLISTER PACK TABLET 10 3 68382-608-77 gabapentin 10 in 1 CARTON TABLET 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68382-608 GABAPENTIN TABLET [ZYDUS PHARMACEUTICALS USA INC.] 2 Current NDC, 4 package rows 20250510_3cfd04ab-e421-441f-a10e-e4dd1412974d.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68382-608-16 68382060816 90 TABLET in 1 BOTTLE (68382-608-16) 90 tablet 2024-01-25 No No Current