CITALOPRAM HYDROBROMIDE

Product NDC: 61919-055
Requested package NDC: 61919-055-30
11-digit product format: 619190055
Labeler code: 61919
Product ID: 61919-055_9cbfe7fe-4021-0df8-e053-2a95a90a72fd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CITALOPRAM HYDROBROMIDE
Dosage form: TABLET
Route: ORAL
Labeler: DIRECT RX
Application: ANDA077032
Marketing category: ANDA
Marketing start: 2014-01-01
Marketing end: 0000-00-00
Substance: CITALOPRAM HYDROBROMIDE
Active strength: 10 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	61919-055	61919-055-30	D	Discontinued by firm		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 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2019-12-08 06:16 UTC · source 2019-12-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A077032-001	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-11-12
A077032-002	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-11-12
A077032-003	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-11-12

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077032-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-11-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077032-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-11-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077032-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-11-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077032-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077032-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077032-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-11-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077032-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077032-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077032-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-11-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077032-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-11-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077032-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-11-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077032-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-11-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077032-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-11-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077032-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-11-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077032-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-11-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077032-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-11-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077032-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-11-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077032-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-11-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077032-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-11-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077032-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-11-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077032-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-11-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077032-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-11-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077032-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-11-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077032-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-11-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077032-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-11-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077032-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-11-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077032-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-11-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077032-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-11-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077032-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-11-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077032-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-11-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077032-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-11-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077032-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-11-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077032-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-11-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077032-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-11-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077032-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-11-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077032-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-11-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077032-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-11-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077032-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-11-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077032-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-11-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077032-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-11-12	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A077032-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077032-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077032-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077032-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077032-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077032-003	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-055-30	2023-01-30	C162847	48780-1	f386c649-e799-0266-e053-dadaa90a7c1a	CITALOPRAM HYDROBROMIDE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CITALOPRAM HYDROBROMIDE	ACTIVE INGREDIENT	I1E9D14F36	CITALOPRAM HYDROBROMIDE TABLET [DIRECT RX]	1
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	CITALOPRAM HYDROBROMIDE TABLET [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CITALOPRAM HYDROBROMIDE TABLET [DIRECT RX]	1
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	CITALOPRAM HYDROBROMIDE TABLET [DIRECT RX]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CITALOPRAM HYDROBROMIDE TABLET [DIRECT RX]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CITALOPRAM HYDROBROMIDE TABLET [DIRECT RX]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CITALOPRAM HYDROBROMIDE TABLET [DIRECT RX]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	CITALOPRAM HYDROBROMIDE TABLET [DIRECT RX]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CITALOPRAM HYDROBROMIDE TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CITALOPRAM HYDROBROMIDE TABLET [DIRECT RX]	1
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	CITALOPRAM HYDROBROMIDE TABLET [DIRECT RX]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CITALOPRAM HYDROBROMIDE TABLET [DIRECT RX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CITALOPRAM HYDROBROMIDE TABLET [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CITALOPRAM HYDROBROMIDE TABLET [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-055	CITALOPRAM HYDROBROMIDE TABLET [DIRECT RX]	3	Legacy NDC	20200123_584aacad-7817-4a90-a810-08b33c61ac5a.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-055-30	61919005530	30 TABLET in 1 BOTTLE (61919-055-30)	30 tablet	2015-01-01	0000-00-00	No	No	Current