Home NDC 42806-300 Nizatidine
Product NDC 42806-300
11-digit product format 428060300
Labeler code 42806
Product ID 42806-300_e9957997-8b85-48a0-9bb3-b878cb223236
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nizatidine
Dosage form CAPSULE
Route ORAL
Labeler Epic Pharma, LLC
Application ANDA076178
Marketing category ANDA
Marketing start 2024-10-25
Substance NIZATIDINE
Active strength 300 mg/1
Pharmacologic classes Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076178-001 NIZATIDINE NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-05 A076178-002 NIZATIDINE NIZATIDINE 300MG CAPSULE / ORAL AB 2002-07-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 · 86 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 A076178-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076178-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2002-07-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076178-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076178-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2002-07-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076178-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076178-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2002-07-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076178-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076178-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2002-07-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076178-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076178-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2002-07-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076178-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076178-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2002-07-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076178-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076178-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2002-07-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076178-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076178-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2002-07-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076178-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076178-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2002-07-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076178-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076178-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2002-07-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076178-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076178-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2002-07-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076178-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076178-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2002-07-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076178-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076178-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2002-07-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076178-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076178-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2002-07-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076178-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076178-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2002-07-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076178-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076178-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2002-07-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076178-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076178-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2002-07-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076178-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076178-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2002-07-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076178-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-05 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076178-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2002-07-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076178-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-05 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076178-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2002-07-05 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Nizatidine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NIZATIDINE 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination P41PML4GHR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198041 Internal RxNorm lookup 312025 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 42806-300-30 Nizatidine 30 in 1 BOTTLE CAPSULE 30 1 42806-300-60 Nizatidine 60 in 1 BOTTLE CAPSULE 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42806-300 NIZATIDINE CAPSULE [EPIC PHARMA, LLC] 1 Current NDC, 2 package rows 20250104_e9957997-8b85-48a0-9bb3-b878cb223236.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 · 1 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 42806-300-30 42806030030 30 CAPSULE in 1 BOTTLE (42806-300-30) 30 capsule 2024-10-25 No No Current 42806-300-60 42806030060 60 CAPSULE in 1 BOTTLE (42806-300-60) 60 capsule 2024-10-25 No No Current