Citalopram Hydrobromide

Product NDC: 54838-540
Requested package NDC: 54838-540-70
11-digit product format: 548380540
Labeler code: 54838
Product ID: 54838-540_8e2a2cfe-8458-4e42-b0a2-aefd6993b0a2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Citalopram Hydrobromide
Dosage form: SOLUTION
Route: ORAL
Labeler: Lannett Company, Inc.
Application: ANDA077629
Marketing category: ANDA
Marketing start: 2006-06-14
Marketing end: 2023-10-31
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: 0000-00-00
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	54838-540	54838-540-70	D	Discontinued by firm		2026-08-11

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 · 12 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…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A077629-001	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA		2006-06-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077629-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077629-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2006-06-15	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077629-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077629-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077629-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077629-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077629-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077629-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077629-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077629-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077629-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077629-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077629-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077629-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077629-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077629-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077629-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077629-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077629-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077629-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077629-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077629-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077629-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077629-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077629-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077629-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077629-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077629-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077629-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077629-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077629-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077629-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077629-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077629-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077629-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077629-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077629-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077629-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077629-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077629-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077629-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077629-001	AA	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
475812f9-1b2c-4cb0-9e72-1e52f935ae6f	Product name	1	20221114
0b05d650-9b7b-4b36-a6f4-1a850d5a2e64	Product name	1	20151228
e61ea6cb-0b08-40a9-a984-7b23201c7aa2	Product name	1	20151222
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54838-540-70	ML - Milliliter	54838-540	e2060446-38a9-4e0a-bdab-f8566459cfb0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Citalopram Hydrobromide	ACTIVE INGREDIENT	I1E9D14F36	CITALOPRAM HYDROBROMIDE SOLUTION [SILARX PHARMACEUTICALS, INC]	20
Citalopram	ACTIVE MOIETY	0DHU5B8D6V	CITALOPRAM HYDROBROMIDE SOLUTION [SILARX PHARMACEUTICALS, INC]	20
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	CITALOPRAM HYDROBROMIDE SOLUTION [SILARX PHARMACEUTICALS, INC]	20
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	CITALOPRAM HYDROBROMIDE SOLUTION [SILARX PHARMACEUTICALS, INC]	20
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	CITALOPRAM HYDROBROMIDE SOLUTION [SILARX PHARMACEUTICALS, INC]	20
sorbitol	INACTIVE INGREDIENT	506T60A25R	CITALOPRAM HYDROBROMIDE SOLUTION [SILARX PHARMACEUTICALS, INC]	20
water	INACTIVE INGREDIENT	059QF0KO0R	CITALOPRAM HYDROBROMIDE SOLUTION [SILARX PHARMACEUTICALS, INC]	20

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	CITALOPRAM	Chartwell RX, LLC	b1f0c6e8-85eb-4368-8709-9cace32415cb	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077629 application number: ANDA077629
Citalopram	CITALOPRAM	Chartwell Governmental & Specialty RX, LLC.	3114274f-d81f-4b1f-8f17-35db9eee2ffe	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077629 application number: ANDA077629

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	1f7a3c37-45cc-4274-930d-24019b870311	2
309313	citalopram 2 MG/ML Oral Solution	SCD	1f7a3c37-45cc-4274-930d-24019b870311	2
309313	citalopram (as citalopram hydrobromide) 2 MG/ML Oral Solution	SY	1f7a3c37-45cc-4274-930d-24019b870311	2
309313	citalopram 10 MG per 5 ML Oral Solution	SY	1f7a3c37-45cc-4274-930d-24019b870311	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54838-540-70	54838054070	240 mL in 1 BOTTLE, PLASTIC (54838-540-70)	240 ml	2006-06-14	2023-10-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Citalopram Oral Solution, USP Rx Only	Lannett Company, Inc.	2021-06-23	HUMAN PRESCRIPTION DRUG LABEL	31
Citalopram Oral Solution, USP	Pharmaceutical Associates, Inc. \| Lannett Company, Inc.	2019-04-08	HUMAN PRESCRIPTION DRUG LABEL	2
Citalopram Oral Solution, USP	Atlantic Biologicals Corps	2016-05-04	HUMAN PRESCRIPTION DRUG LABEL	2