Home NDC 55111-311 Nizatidine
Product NDC 55111-311
11-digit product format 551110311
Labeler code 55111
Product ID 55111-311_254e5866-1ba8-8d97-bc03-19916119ff87
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nizatidine
Dosage form CAPSULE
Route ORAL
Labeler Dr Reddy's Laboratories Limited
Application ANDA077314
Marketing category ANDA
Marketing start 2005-09-15
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 A077314-001 NIZATIDINE NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 A077314-002 NIZATIDINE NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15
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 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 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# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55111-311 NIZATIDINE CAPSULE [DR REDDY'S LABORATORIES LIMITED] 3 Current NDC, Legacy NDC, 6 package rows 20190312_faaa7cc4-fda9-d5b8-de2a-71c8744ccb76.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 Marketing end Sample Exclude flag Status 55111-311-01 55111031101 100 CAPSULE in 1 BOTTLE (55111-311-01) 100 capsule 2005-09-15 0000-00-00 No No Current 55111-311-05 55111031105 500 CAPSULE in 1 BOTTLE (55111-311-05) 500 capsule 2005-09-15 0000-00-00 No No Current 55111-311-30 55111031130 30 CAPSULE in 1 BOTTLE (55111-311-30) 30 capsule 2005-09-15 0000-00-00 No No Current 55111-311-60 55111031160 60 CAPSULE in 1 BOTTLE (55111-311-60) 60 capsule 2005-09-15 0000-00-00 No No Current 55111-311-78 55111031178 10 BLISTER PACK in 1 CARTON (55111-311-78) / 10 CAPSULE in 1 BLISTER PACK (55111-311-79) 10 blister pack 2005-09-15 0000-00-00 No No Current 55111-311-79 55111031179 10 in 1 BLISTER PACK Historical