CIMETIDINE HYDROCHLORIDE

Product NDC
50383-966
11-digit product format
503830966
Labeler code
50383
Product ID
50383-966_478a5f78-dd99-4476-9c97-b963da080c3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CIMETIDINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
Akorn
Application
ANDA074664
Marketing category
ANDA
Marketing start
2020-10-29
Marketing end
0000-00-00
Substance
CIMETIDINE HYDROCHLORIDE
Active strength
300 mg/5mL
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct50383-966IInactivated by FDA2026-10-05
excluded packagepackage50383-96650383-966-08IInactivated by FDA2026-10-05

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 · 30 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 packagepackage50383-966-08d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50383-966-08f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50383-966-082ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50383-966-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50383-966-08cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50383-966-08cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50383-966-08302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50383-966-08ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50383-966-080efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50383-966-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50383-966-08367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50383-966-08557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50383-966-088af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50383-966-08834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50383-966-081332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074664-001CIMETIDINE HYDROCHLORIDECIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A074664-001AA

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-2884e616aacf4f…
2026-08-18 06:07:402026-07A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORAL1997-10-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALRS1997-10-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALRS1997-10-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORAL1997-10-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORAL1997-10-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORAL1997-10-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORAL1997-10-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-283f01610625f2…
2019-09-15 20:21 UTC2019-09A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORAL1997-10-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074664-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/5MLSOLUTION / ORALAARS1997-10-28f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A074664-001AA184e616aacf4f…
2026-08-18 06:07:402026-07A074664-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074664-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074664-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074664-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074664-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074664-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074664-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074664-001AA12680178bc6a6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074664-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074664-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074664-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074664-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074664-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074664-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074664-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A074664-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074664-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074664-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074664-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A074664-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074664-001AA1ea99ee380514…
2024-02-18 07:12 UTC2024-02A074664-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074664-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074664-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074664-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074664-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074664-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A074664-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A074664-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074664-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074664-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074664-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074664-001AA1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A074664-001AA1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8f48ba86-02a3-4def-9efa-3a8140fd7adfProduct name220250624
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50383-966-082024-01-30C16284748780-11030e365-2473-111a-e063-dadaa90a10e2CIMETIDINE HYDROCHLORIDE ORAL SOLUTION, 300 mg/ 5 mL Rx only Rev.966:00 02/19

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50383-966-08CIMETIDINE HYDROCHLORIDE273 mL in 1 BOTTLESOLUTION2732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-966CIMETIDINE HYDROCHLORIDE SOLUTION [AKORN]2Legacy NDC, 1 package rows20220308_b27f10b3-3913-401c-90a4-f92dc5de763e.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cimetidine HydrochlorideCIMETIDINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharmab8b50bd9-bc1b-4da5-96c5-8eb917c8937f2025-01-06Adverse reactionsExact identifier
application applno (ANDA): 074664
application number: ANDA074664

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
212787cimetidine HCl 300 MG in 5 mL Oral SolutionPSNb27f10b3-3913-401c-90a4-f92dc5de763e2
212787cimetidine 60 MG/ML Oral SolutionSCDb27f10b3-3913-401c-90a4-f92dc5de763e2
212787cimetidine 300 MG per 5 ML Oral SolutionSYb27f10b3-3913-401c-90a4-f92dc5de763e2
212787cimetidine 400 MG per 6.7 ML Oral SolutionSYb27f10b3-3913-401c-90a4-f92dc5de763e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-966-0850383096608273 mL in 1 BOTTLE (50383-966-08) 273 ml2020-10-290000-00-00NoNoCurrent