Home NDC 0185-0150 nizatidine
Product NDC 0185-0150
11-digit product format 001850150
Labeler code 0185
Product ID 0185-0150_b68bb8c1-f574-4c91-8b79-d1296ae7e34c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nizatidine
Dosage form CAPSULE
Route ORAL
Labeler Eon Labs, Inc.
Application ANDA076178
Marketing category ANDA
Marketing start 2002-07-05
Marketing end 2019-12-31
Substance NIZATIDINE
Active strength 150 mg/1
Pharmacologic classes Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NIZATIDINE ACTIVE INGREDIENT P41PML4GHR NIZATIDINE CAPSULE [EON LABS, INC.] 17 NIZATIDINE ACTIVE MOIETY P41PML4GHR NIZATIDINE CAPSULE [EON LABS, INC.] 17 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 NIZATIDINE CAPSULE [EON LABS, INC.] 17 DIMETHICONE 350 INACTIVE INGREDIENT 2Y53S6ATLU NIZATIDINE CAPSULE [EON LABS, INC.] 17 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X NIZATIDINE CAPSULE [EON LABS, INC.] 17 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ NIZATIDINE CAPSULE [EON LABS, INC.] 17 TALC INACTIVE INGREDIENT 7SEV7J4R1U NIZATIDINE CAPSULE [EON LABS, INC.] 17 NIZATIDINE ACTIVE INGREDIENT P41PML4GHR NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP] 1 Nizatidine ACTIVE INGREDIENT P41PML4GHR NIZATIDINE CAPSULE [NIZATIDINE] 1 NIZATIDINE ACTIVE MOIETY P41PML4GHR NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP] 1 Nizatidine ACTIVE MOIETY P41PML4GHR NIZATIDINE CAPSULE [NIZATIDINE] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP] 1 DIMETHICONE 350 INACTIVE INGREDIENT 2Y53S6ATLU NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP] 1 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP] 1
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#