CIMETIDINE HYDROCHLORIDE

Product NDC: 62135-809
11-digit product format: 621350809
Labeler code: 62135
Product ID: 62135-809_4a162075-ab76-d848-e063-6294a90aaa9b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CIMETIDINE HYDROCHLORIDE
Dosage form: SOLUTION
Route: ORAL
Labeler: Chartwell RX, LLC
Application: ANDA074251
Marketing category: ANDA
Marketing start: 1994-12-22
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: 2027-12-31
Current FDA listing: Yes

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
A074251-001	CIMETIDINE HYDROCHLORIDE	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA		1994-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074251-001	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	1994-12-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	1994-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	1994-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	1994-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	1994-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	1994-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	1994-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	1994-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL	AA	1994-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		1994-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		1994-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		1994-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		1994-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		1994-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		1994-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		1994-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		1994-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		1994-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		1994-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		1994-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		1994-12-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		1994-12-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		1994-12-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		1994-12-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		1994-12-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		1994-12-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		1994-12-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		1994-12-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		1994-12-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		1994-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		1994-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		1994-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		1994-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		1994-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		1994-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		1994-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		1994-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		1994-12-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		1994-12-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074251-001	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION / ORAL		1994-12-22	`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	A074251-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074251-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074251-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074251-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074251-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074251-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074251-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074251-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074251-001	AA	1	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A074251-001	AA	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: CIMETIDINE HYDROCHLORIDE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CIMETIDINE HYDROCHLORIDE	300 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WF10491673	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
212787	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d1d73350-4e7e-428a-90a5-6000fd373a4f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8f48ba86-02a3-4def-9efa-3a8140fd7adf	Product name	2	20250624

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
62135-809-05	CIMETIDINE HYDROCHLORIDE	5 mL in 1 CUP	SOLUTION	5	3
62135-809-24	CIMETIDINE HYDROCHLORIDE	10 in 1 TRAY	SOLUTION	10	3
62135-809-24	CIMETIDINE HYDROCHLORIDE	2 in 1 BOX	SOLUTION	2	3
62135-809-37	CIMETIDINE HYDROCHLORIDE	237 mL in 1 BOTTLE	SOLUTION	237	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62135-809-05	ML - Milliliter	62135-809	3633bfe9-d26d-4e1b-8e2c-b8af6d1b97bf	1	2024-11-05
62135-809-24	ML - Milliliter	62135-809	df6da2b4-c290-4a2b-ba03-552dcd8efb45	1	2024-11-05
62135-809-37	ML - Milliliter	62135-809	ae75c93d-3cee-4aae-b887-1e9f6a2826c7	1	2024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62135-809	CIMETIDINE HYDROCHLORIDE SOLUTION [CHARTWELL RX, LLC]	2	Current NDC, 4 package rows	20241025_d1d73350-4e7e-428a-90a5-6000fd373a4f.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CIMETIDINE HYDROCHLORIDE	CIMETIDINE HYDROCHLORIDE	Chartwell RX, LLC	d1d73350-4e7e-428a-90a5-6000fd373a4f	2026-02-05	Adverse reactions	Exact identifier application applno (ANDA): 074251 application number: ANDA074251 ndc (product): 62135-809
CIMETIDINE HYDROCHLORIDE	CIMETIDINE HYDROCHLORIDE	Chartwell Governmental & Specialty RX, LLC.	e40bb1f6-338a-42e7-9217-8c32d14ccfd3	2025-11-04	Adverse reactions	Exact identifier application applno (ANDA): 074251 application number: ANDA074251

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	d1d73350-4e7e-428a-90a5-6000fd373a4f	3
212787	cimetidine 60 MG/ML Oral Solution	SCD	d1d73350-4e7e-428a-90a5-6000fd373a4f	3
212787	cimetidine 300 MG per 5 ML Oral Solution	SY	d1d73350-4e7e-428a-90a5-6000fd373a4f	3
212787	cimetidine 400 MG per 6.7 ML Oral Solution	SY	d1d73350-4e7e-428a-90a5-6000fd373a4f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
62135-809-05	62135080905	5 mL in 1 CUP	5 ml				Historical
62135-809-24	62135080924	2 TRAY in 1 BOX (62135-809-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-809-05)	2 tray	2024-10-22	No	No	Current
62135-809-37	62135080937	237 mL in 1 BOTTLE (62135-809-37)	237 ml	2024-05-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CIMETIDINE HYDROCHLORIDE ORAL SOLUTION	Chartwell RX, LLC	2026-02-05	HUMAN PRESCRIPTION DRUG LABEL	3