Home NDC 52959-824 Nizatidine
Product NDC 52959-824
11-digit product format 529590824
Labeler code 52959
Product ID 52959-824_6dce31da-352d-47ef-9f8d-d4e2466a06a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nizatidine
Dosage form CAPSULE
Route ORAL
Labeler H.J. Harkins Company, Inc.
Application ANDA075616
Marketing category ANDA
Marketing start 2002-07-09
Marketing end 0000-00-00
Substance NIZATIDINE
Active strength 150 mg/1
Pharmacologic classes Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag E
Listing certified through 2018-12-31
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 2 · 66 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 A075616-001 NIZATIDINE NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 A075616-002 NIZATIDINE NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09
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 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2002-07-09 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52959-824-30 Nizatidine 30 in 1 BOTTLE, PLASTIC CAPSULE 30 1 52959-824-60 Nizatidine 60 in 1 BOTTLE, PLASTIC CAPSULE 60 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NIZATIDINE ACTIVE INGREDIENT P41PML4GHR NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 NIZATIDINE ACTIVE MOIETY P41PML4GHR NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 AMMONIA INACTIVE INGREDIENT 5138Q19F1X NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 FERRIC OXIDE BLACK INACTIVE INGREDIENT XM0M87F357 NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52959-824 NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 Legacy NDC, 2 package rows 20111209_33cf4324-44cb-44df-b459-7319a335b253.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 Status 52959-824-30 52959082430 30 in 1 BOTTLE, PLASTIC Historical 52959-824-60 52959082460 60 in 1 BOTTLE, PLASTIC Historical