citalopram hydrobromide

Product NDC: 57664-508
Requested package NDC: 57664-508-18
11-digit product format: 576640508
Labeler code: 57664
Product ID: 57664-508_ef44872c-ba5e-d69b-e053-2a95a90adb55
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: citalopram hydrobromide
Dosage form: TABLET
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA077032
Marketing category: ANDA
Marketing start: 2015-05-29
Marketing end: 0000-00-00
Substance: CITALOPRAM HYDROBROMIDE
Active strength: 20 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
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	57664-508	57664-508-18	D	Discontinued by firm		2026-10-05

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.

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57664-508-13	EA - Each	57664-508	997f6ba5-b3a0-4df5-9c94-f8f8e2190684	1	2012-07-24
57664-508-18	EA - Each	57664-508	074dbefa-86e1-4022-a5c5-440a91fb0775	1	2012-07-24
57664-508-83	EA - Each	57664-508	63b08cba-4260-4f54-a30f-06f851a2ad54	1	2013-02-11
57664-508-88	EA - Each	57664-508	3083466e-ffbc-4f62-9509-b516a9c3430d	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 TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	13
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	13
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	13
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	13
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	13
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	13
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	13
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	13
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	13
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	13
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	13
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	13
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	13
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	13
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	13
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	13
CITALOPRAM HYDROBROMIDE	ACTIVE INGREDIENT	I1E9D14F36	CITALOPRAM TABLET [DIRECT RX]	3
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	CITALOPRAM TABLET [DIRECT RX]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CITALOPRAM TABLET [DIRECT RX]	3
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	CITALOPRAM TABLET [DIRECT RX]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CITALOPRAM TABLET [DIRECT RX]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CITALOPRAM TABLET [DIRECT RX]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CITALOPRAM TABLET [DIRECT RX]	3
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	CITALOPRAM TABLET [DIRECT RX]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CITALOPRAM TABLET [DIRECT RX]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CITALOPRAM TABLET [DIRECT RX]	3
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	CITALOPRAM TABLET [DIRECT RX]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CITALOPRAM TABLET [DIRECT RX]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CITALOPRAM TABLET [DIRECT RX]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CITALOPRAM TABLET [DIRECT RX]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57664-508	CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	18	Legacy NDC	20221209_52bf0f9e-e6c3-4dd8-921d-2e74605e07d1.zip

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
200371	citalopram 20 MG Oral Tablet	PSN	b4c389f0-0dad-4fec-ad7d-4223528beb35	3
200371	citalopram 20 MG Oral Tablet	SCD	b4c389f0-0dad-4fec-ad7d-4223528beb35	3
200371	citalopram 20 MG (as citalopram HBr 24.99 MG) Oral Tablet	SY	b4c389f0-0dad-4fec-ad7d-4223528beb35	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57664-508-18	57664050818	1000 TABLET in 1 BOTTLE (57664-508-18)	1000 tablet	2015-05-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Citalopram Tablets, USP 10 mg, 20 mg and 40 mg Rx only	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2022-12-07	HUMAN PRESCRIPTION DRUG LABEL	18
CITALOPRAM HYDROBROMIDE	DIRECT RX	2015-08-14	HUMAN PRESCRIPTION DRUG LABEL	3