Home NDC 0591-3137-60 Nizatidine
Product NDC 0591-3137
Requested package NDC 0591-3137-60
11-digit product format 005913137
Labeler code 0591
Product ID 0591-3137_0920fca7-e74b-49fb-809b-ef720690752e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nizatidine
Dosage form CAPSULE
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA075616
Marketing category ANDA
Marketing start 2002-07-09
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 82 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 2026-02-19 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…2022-03-09 01:35 UTC 2022-03 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 150 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 0591-3137-60 Nizatidine 60 in 1 BOTTLE, PLASTIC CAPSULE 60 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NIZATIDINE ACTIVE INGREDIENT P41PML4GHR NIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT] 2 NIZATIDINE ACTIVE INGREDIENT P41PML4GHR NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.] 2 NIZATIDINE ACTIVE MOIETY P41PML4GHR NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.] 2 NIZATIDINE ACTIVE MOIETY P41PML4GHR NIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT] 2 AMMONIA INACTIVE INGREDIENT 5138Q19F1X NIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT] 2 AMMONIA INACTIVE INGREDIENT 5138Q19F1X NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.] 2 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 NIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G NIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 NIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.] 2 FERRIC OXIDE BLACK INACTIVE INGREDIENT XM0M87F357 NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 NIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L NIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT] 2 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T NIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT] 2 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT] 2 SHELLAC INACTIVE INGREDIENT 46N107B71O NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.] 2 SHELLAC INACTIVE INGREDIENT 46N107B71O NIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J NIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ NIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT] 2 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT] 2 NIZATIDINE ACTIVE INGREDIENT P41PML4GHR NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 NIZATIDINE ACTIVE INGREDIENT P41PML4GHR NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP] 1 NIZATIDINE ACTIVE MOIETY P41PML4GHR NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 NIZATIDINE ACTIVE MOIETY P41PML4GHR NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP] 1 AMMONIA INACTIVE INGREDIENT 5138Q19F1X NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP] 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 [REBEL DISTRIBUTORS CORP] 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 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP] 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 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP] 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 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP] 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 [REBEL DISTRIBUTORS CORP] 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 0591-3137 NIZATIDINE CAPSULE [ACTAVIS PHARMA, INC.] 9 Current NDC, Legacy NDC, 1 package rows 20241228_367a1004-59c1-4474-a4f6-ce8bf5a1b043.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 0591-3137-60 00591313760 60 CAPSULE in 1 BOTTLE, PLASTIC (0591-3137-60) 60 capsule 2002-07-09 0000-00-00 No No Current