Citalopram Hydrobromide

Product NDC: 31722-564
11-digit product format: 317220564
Labeler code: 31722
Product ID: 31722-564_1285242d-4c02-8735-e063-6294a90aa6ad
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Citalopram Hydrobromide
Dosage form: SOLUTION
Route: ORAL
Labeler: Camber Pharmaceuticals, Inc.
Application: ANDA201450
Marketing category: ANDA
Marketing start: 2015-12-21
Substance: CITALOPRAM HYDROBROMIDE
Active strength: 10 mg/5mL
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
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 42.

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
A201450-001	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA		2015-12-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201450-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201450-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2015-12-15	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A201450-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201450-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201450-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201450-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201450-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201450-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201450-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201450-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201450-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201450-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201450-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201450-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201450-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201450-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201450-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201450-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201450-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201450-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201450-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201450-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201450-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201450-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201450-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201450-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201450-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201450-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201450-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201450-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201450-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201450-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201450-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201450-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201450-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201450-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201450-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201450-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201450-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201450-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201450-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201450-001	AA	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Citalopram Hydrobromide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CITALOPRAM HYDROBROMIDE	10 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
I1E9D14F36	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309313	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
dc7b3f88-ee55-4e3e-9ed4-fc06aa7620cc	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
475812f9-1b2c-4cb0-9e72-1e52f935ae6f	Product name	1	20221114
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
0b05d650-9b7b-4b36-a6f4-1a850d5a2e64	Product name	1	20151228
e61ea6cb-0b08-40a9-a984-7b23201c7aa2	Product name	1	20151222
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
31722-564-24	Citalopram Hydrobromide	240 mL in 1 BOTTLE	SOLUTION	240		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
31722-564-24	ML - Milliliter	31722-564	7c2ef5fd-3f71-45d6-a7f5-7c9528f896ca	1	2018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
31722-564	CITALOPRAM HYDROBROMIDE (CITALOPRAM HYDROBROMIDE) SOLUTION [CAMBER PHARMACEUTICALS, INC.]	3	Current NDC, Legacy NDC, 1 package rows	20240301_dc7b3f88-ee55-4e3e-9ed4-fc06aa7620cc.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
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	ATLANTIC BIOLOGICALS CORP.	2640311d-8b88-4513-9c80-a08390b8142a	2025-05-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201450 application number: ANDA201450
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Camber Pharmaceuticals, Inc.	dc7b3f88-ee55-4e3e-9ed4-fc06aa7620cc	2024-02-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201450 application number: ANDA201450 ndc (product): 31722-564

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
I1E9D14F36	CITALOPRAM HYDROBROMIDE	59729-32-7	CITALOPRAM HYDROBROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309313	citalopram 10 MG in 5 mL Oral Solution	PSN	2640311d-8b88-4513-9c80-a08390b8142a	4
309313	citalopram 2 MG/ML Oral Solution	SCD	2640311d-8b88-4513-9c80-a08390b8142a	4
309313	citalopram (as citalopram hydrobromide) 2 MG/ML Oral Solution	SY	2640311d-8b88-4513-9c80-a08390b8142a	4
309313	citalopram 10 MG per 5 ML Oral Solution	SY	2640311d-8b88-4513-9c80-a08390b8142a	4
309313	citalopram 10 MG in 5 mL Oral Solution	PSN	dc7b3f88-ee55-4e3e-9ed4-fc06aa7620cc	3
309313	citalopram 2 MG/ML Oral Solution	SCD	dc7b3f88-ee55-4e3e-9ed4-fc06aa7620cc	3
309313	citalopram (as citalopram hydrobromide) 2 MG/ML Oral Solution	SY	dc7b3f88-ee55-4e3e-9ed4-fc06aa7620cc	3
309313	citalopram 10 MG per 5 ML Oral Solution	SY	dc7b3f88-ee55-4e3e-9ed4-fc06aa7620cc	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
31722-564-24	31722056424	240 mL in 1 BOTTLE (31722-564-24)	240 ml	2015-12-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CITALOPRAM Oral Solution, USP Rx only	ATLANTIC BIOLOGICALS CORP.	2025-05-12	HUMAN PRESCRIPTION DRUG LABEL	4
Citalopram Oral Solution, USP Rx only	Camber Pharmaceuticals, Inc. \| Hetero Labs Limited Unit III	2024-02-29	HUMAN PRESCRIPTION DRUG LABEL	3