CIMETIDINE HYDROCHLORIDE

Product NDC: 50383-966
Requested package NDC: 50383-966-08
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50383-966	50383-966-08	I	Inactivated by FDA		2026-10-05

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074664-001	CIMETIDINE HYDROCHLORIDE	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28

Therapeutic equivalence codes#

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

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

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
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	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL			1997-10-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		RS	1997-10-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		RS	1997-10-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL			1997-10-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL			1997-10-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL			1997-10-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL			1997-10-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL			1997-10-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074664-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	RS	1997-10-28	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A074664-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074664-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074664-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074664-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074664-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074664-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074664-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074664-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074664-001	AA	1	`2680178bc6a6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074664-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074664-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074664-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074664-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074664-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074664-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074664-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074664-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074664-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074664-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074664-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074664-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074664-001	AA	1	`ea99ee380514…`
2024-02-18 07:12 UTC	2024-02	A074664-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074664-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074664-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074664-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074664-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074664-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074664-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074664-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074664-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074664-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074664-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074664-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A074664-001	AA	1	`a50c72e98297…`

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 concept	Relation	Version	Effective
8f48ba86-02a3-4def-9efa-3a8140fd7adf	Product name	2	20250624
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50383-966-08	2024-01-30	C162847	48780-1	1030e365-2473-111a-e063-dadaa90a10e2	CIMETIDINE HYDROCHLORIDE ORAL SOLUTION, 300 mg/ 5 mL Rx only Rev.966:00 02/19

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50383-966-08	CIMETIDINE HYDROCHLORIDE	273 mL in 1 BOTTLE	SOLUTION	273		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50383-966	CIMETIDINE HYDROCHLORIDE SOLUTION [AKORN]	2	Legacy NDC, 1 package rows	20220308_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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cimetidine Hydrochloride	CIMETIDINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	b8b50bd9-bc1b-4da5-96c5-8eb917c8937f	2025-01-06	Adverse reactions	Exact identifier application applno (ANDA): 074664 application number: ANDA074664

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WF10491673	CIMETIDINE HYDROCHLORIDE	70059-30-2	CIMETIDINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
212787	cimetidine HCl 300 MG in 5 mL Oral Solution	PSN	b27f10b3-3913-401c-90a4-f92dc5de763e	2
212787	cimetidine 60 MG/ML Oral Solution	SCD	b27f10b3-3913-401c-90a4-f92dc5de763e	2
212787	cimetidine 300 MG per 5 ML Oral Solution	SY	b27f10b3-3913-401c-90a4-f92dc5de763e	2
212787	cimetidine 400 MG per 6.7 ML Oral Solution	SY	b27f10b3-3913-401c-90a4-f92dc5de763e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50383-966-08	50383096608	273 mL in 1 BOTTLE (50383-966-08)	273 ml	2020-10-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CIMETIDINE HYDROCHLORIDE ORAL SOLUTION, 300 mg/ 5 mL Rx only Rev.966:00 02/19	Akorn \| Akorn Operating Company LLC	2022-03-07	HUMAN PRESCRIPTION DRUG LABEL	2