Nizatidine

Product NDC
45865-374
11-digit product format
458650374
Labeler code
45865
Product ID
45865-374_1d6161e3-2dda-5446-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nizatidine
Dosage form
CAPSULE
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA090618
Marketing category
ANDA
Marketing start
2011-07-15
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
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct45865-374IInactivated by FDA2026-09-14
excluded packagepackage45865-37445865-374-60IInactivated by FDA2026-09-14

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 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage45865-374-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45865-374-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage45865-374-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage45865-374-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage45865-374-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage45865-374-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage45865-374-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage45865-374-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage45865-374-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage45865-374-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage45865-374-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage45865-374-60557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage45865-374-608af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage45865-374-60834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage45865-374-601332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage45865-374-60fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage45865-374-6086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage45865-374-60bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage45865-374-608dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage45865-374-60e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage45865-374-609bebd1f3094a…5416666fcb17…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090618-001NIZATIDINENIZATIDINE150MGCAPSULE / ORAL2011-07-15
A090618-002NIZATIDINENIZATIDINE300MGCAPSULE / ORAL2011-07-15

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090618-001NIZATIDINE150MGCAPSULE / ORAL2011-07-1584e616aacf4f…
2026-09-14 22:38:342026-08A090618-002NIZATIDINE300MGCAPSULE / ORAL2011-07-1584e616aacf4f…
2026-08-18 06:07:402026-07A090618-001NIZATIDINE150MGCAPSULE / ORAL2011-07-15caaa826d4ba7…
2026-08-18 06:07:402026-07A090618-002NIZATIDINE300MGCAPSULE / ORAL2011-07-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090618-001NIZATIDINE150MGCAPSULE / ORAL2011-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090618-002NIZATIDINE300MGCAPSULE / ORAL2011-07-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090618-001NIZATIDINE150MGCAPSULE / ORAL2011-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090618-002NIZATIDINE300MGCAPSULE / ORAL2011-07-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A090618-001NIZATIDINE150MGCAPSULE / ORAL2011-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090618-002NIZATIDINE300MGCAPSULE / ORAL2011-07-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090618-001NIZATIDINE150MGCAPSULE / ORALAB2011-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090618-002NIZATIDINE300MGCAPSULE / ORALAB2011-07-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090618-001NIZATIDINE150MGCAPSULE / ORALAB2011-07-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090618-002NIZATIDINE300MGCAPSULE / ORALAB2011-07-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090618-001NIZATIDINE150MGCAPSULE / ORALAB2011-07-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090618-002NIZATIDINE300MGCAPSULE / ORALAB2011-07-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090618-001NIZATIDINE150MGCAPSULE / ORALAB2011-07-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090618-002NIZATIDINE300MGCAPSULE / ORALAB2011-07-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090618-001NIZATIDINE150MGCAPSULE / ORALAB2011-07-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090618-002NIZATIDINE300MGCAPSULE / ORALAB2011-07-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090618-001NIZATIDINE150MGCAPSULE / ORALAB2011-07-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090618-002NIZATIDINE300MGCAPSULE / ORALAB2011-07-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090618-001NIZATIDINE150MGCAPSULE / ORALAB2011-07-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A090618-002NIZATIDINE300MGCAPSULE / ORALAB2011-07-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090618-001NIZATIDINE150MGCAPSULE / ORALAB2011-07-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090618-002NIZATIDINE300MGCAPSULE / ORALAB2011-07-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090618-001NIZATIDINE150MGCAPSULE / ORALAB2011-07-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090618-002NIZATIDINE300MGCAPSULE / ORALAB2011-07-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090618-001NIZATIDINE150MGCAPSULE / ORALAB2011-07-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090618-002NIZATIDINE300MGCAPSULE / ORALAB2011-07-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090618-001NIZATIDINE150MGCAPSULE / ORALAB2011-07-158072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090618-002NIZATIDINE300MGCAPSULE / ORALAB2011-07-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090618-001NIZATIDINE150MGCAPSULE / ORALAB2011-07-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090618-002NIZATIDINE300MGCAPSULE / ORALAB2011-07-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090618-001NIZATIDINE150MGCAPSULE / ORALAB2011-07-155d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090618-002NIZATIDINE300MGCAPSULE / ORALAB2011-07-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090618-001NIZATIDINE150MGCAPSULE / ORALAB2011-07-154b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090618-002NIZATIDINE300MGCAPSULE / ORALAB2011-07-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090618-001NIZATIDINE150MGCAPSULE / ORALAB2011-07-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090618-002NIZATIDINE300MGCAPSULE / ORALAB2011-07-1574a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090618-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090618-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090618-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090618-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090618-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090618-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090618-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090618-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090618-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090618-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090618-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090618-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090618-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090618-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090618-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090618-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090618-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090618-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090618-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090618-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090618-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090618-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090618-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090618-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090618-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090618-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090618-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090618-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090618-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090618-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090618-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090618-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090618-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090618-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090618-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090618-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090618-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090618-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090618-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090618-002AB18869cabd3fbd…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5c362336-b506-4bdc-6f70-74c97a4a3342Product name120140508
6f755c6f-b906-f8da-e39d-305610ef9195Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-374-602020-01-31C16284748780-19d75b9d0-79e7-f424-e053-dadaa90a57ceNizatidine Capsules USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-374-60Nizatidine60 in 1 BOTTLECAPSULE601

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NIZATIDINEACTIVE INGREDIENTP41PML4GHRNIZATIDINE CAPSULE [MEDSOURCE PHARMACEUTICALS]1
NIZATIDINEACTIVE MOIETYP41PML4GHRNIZATIDINE CAPSULE [MEDSOURCE PHARMACEUTICALS]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNIZATIDINE CAPSULE [MEDSOURCE PHARMACEUTICALS]1
GELATININACTIVE INGREDIENT2G86QN327LNIZATIDINE CAPSULE [MEDSOURCE PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NIZATIDINE CAPSULE [MEDSOURCE PHARMACEUTICALS]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENIZATIDINE CAPSULE [MEDSOURCE PHARMACEUTICALS]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNIZATIDINE CAPSULE [MEDSOURCE PHARMACEUTICALS]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2NIZATIDINE CAPSULE [MEDSOURCE PHARMACEUTICALS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNIZATIDINE CAPSULE [MEDSOURCE PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIZATIDINE CAPSULE [MEDSOURCE PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-374NIZATIDINE CAPSULE [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20150819_1d6161e3-2ddb-5446-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312025nizatidine 150 MG Oral CapsulePSN1d6161e3-2ddb-5446-e054-00144ff8d46c1
312025nizatidine 150 MG Oral CapsuleSCD1d6161e3-2ddb-5446-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
45865-374-604586503746060 in 1 BOTTLEHistorical