CITALOPRAM

Manufacturer: DIRECT RX
Effective date: 2016-04-12
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:22:11

Label at a glance#

ProductCITALOPRAM

Active ingredientCITALOPRAM HYDROBROMIDE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CITALOPRAM 10mg 30 TABS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
283672	citalopram 10 MG Oral Tablet	PSN	1
283672	citalopram 10 MG Oral Tablet	SCD	1
283672	citalopram 10 MG (as citalopram HBr 12.49 MG) Oral Tablet	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
CITALOPRAM Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-288-30	CITALOPRAM	30 in 1 BOTTLE	TABLET, FILM COATED	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-288	CITALOPRAM TABLET, FILM COATED [DIRECT RX]	1	Legacy NDC, 1 package rows	20160413_304f1d5a-218f-51ae-e054-00144ff88e88.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-288-30	EA - Each	61919-288	54477e8d-d1d5-485b-97a8-e7c63514f1f1	1	2016-09-02
65162-052-03	EA - Each	65162-052	ce515dd7-9f90-4ef1-bb93-132d3693c4c7	1	2013-02-13
65162-052-10	EA - Each	65162-052	201ee70a-34a2-4ad6-b931-d60463d51e5e	1	2012-07-24
65162-052-50	EA - Each	65162-052	ea71cf45-b903-4ac2-9542-5a4f04a0b2b0	1	2012-07-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

CITALOPRAM
GLYCERIN
LACTOSE MONOHYDRATE
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
MAGNESIUM STEARATE
POLYETHYLENE GLYCOLS
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
CITALOPRAM HYDROBROMIDE
POVIDONE K12

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61919-288	61919-288-30
65162-052

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GLYCERIN	PDC6A3C0OX	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
POLYVINYL ALCOHOL	532B59J990	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
STARCH, CORN	O8232NY3SJ	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYETHYLENE GLYCOLS	3WJQ0SDW1A	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
TALC	7SEV7J4R1U	IACT
CITALOPRAM HYDROBROMIDE	I1E9D14F36	ACTIM
POVIDONE K12	333AG72FWJ	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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
A077289-001	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2006-11-30
A077289-002	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2006-11-30
A077289-003	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2006-11-30

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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077289-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL		2006-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077289-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL		2006-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077289-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL		2006-11-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077289-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL		2006-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077289-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL		2006-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077289-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL		2006-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077289-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077289-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077289-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077289-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077289-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077289-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077289-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077289-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077289-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077289-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077289-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077289-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077289-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077289-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077289-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077289-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077289-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077289-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077289-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077289-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077289-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077289-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077289-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077289-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077289-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077289-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077289-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077289-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077289-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077289-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077289-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-11-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077289-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-11-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077289-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077289-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-11-30	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 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	A077289-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077289-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077289-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077289-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077289-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077289-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077289-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077289-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077289-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077289-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077289-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077289-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077289-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077289-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077289-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077289-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077289-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077289-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077289-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077289-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077289-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077289-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077289-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077289-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077289-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077289-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077289-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077289-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077289-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077289-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077289-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077289-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077289-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077289-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077289-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077289-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077289-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077289-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077289-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077289-001	AB	1	`8072bd15b7f6…`

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	Amneal Pharmaceuticals LLC	6a402640-1c9d-4fca-8b5b-e1ac1dd4ca5a	2024-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 65162-052
304f1d5a-2190-51ae-e054-00144ff88e88			304f1d5a-218f-51ae-e054-00144ff88e88	2016-04-12	Warnings, Adverse reactions	Exact identifier spl id: 304f1d5a-2190-51ae-e054-00144ff88e88 spl set id: 304f1d5a-218f-51ae-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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