Citalopram

Product NDC: 13668-010
11-digit product format: 136680010
Labeler code: 13668
Product ID: 13668-010_48423caf-4df2-4653-a8ed-b28462757ed3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Citalopram
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Torrent Pharmaceuticals Limited
Application: ANDA078216
Marketing category: ANDA
Marketing start: 2007-10-18
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: 2027-12-31
Current FDA listing: Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078216-001	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27
A078216-002	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-27
A078216-003	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-27

Therapeutic equivalence codes#

Application-product, TE code table
Application-product	TE code
A078216-001	AB
A078216-002	AB
A078216-003	AB

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Citalopram	CITALOPRAM	Torrent Pharmaceuticals Limited	04766f1d-7a69-49ed-8fd3-1a6305505d47	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier

Boxed warning cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

boxed warning

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short- term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.1 )] . Citalopram tablets are not approved for use in pediatric patients [see Use in Specific Populations ( 8.4 )] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning . • Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors ( 5.1 ) . • Citalopram tablets are not approved for use in pediatric patients ( 8.4 ) .

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings and cautions

5 WARNINGS AND PRECAUTIONS • QT-Prolongation and Torsade de Pointes: Dose-dependent QTc prolongation, Torsade de pointes, ventricular tachycardia, and sudden death have occurred. Avoid use of citalopram tablets in patients with congenital long QT syndrome, bradycardia, hypokalemia or hypomagnesemia, recent acute myocardial infarction, or uncompensated heart failure and patients taking other drugs that prolong the QTc interval. Monitor electrolytes in patients at high risk for hypokalemia or hypomagnesemia. Discontinue citalopram tablets in patients with persistent QTc measurements > 500 ms ( 5.2 , 7 ). • Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents, but also when taken alone. If occurs, discontinue citalopram tablets and serotonergic agents and initiate supportive measures ( 5.3 ). • Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti- inflammatory drugs, other antiplatelet drugs, warfarin and other anticoagulants may increase this risk ( 5.4 ). • Activation of Mania/Hypomania: Screen patients for bipolar disorder ( 5.5 ). • Seizures: Use with caution in patients with seizure disorder ( 5.7 ). • Angle-Closure Glaucoma: Avoid use of citalopram tablets in patients with untreated anatomically narrow angles ( 5.8 ). • Hyponatremia: Can occur in association with syndrome of inappropriate antidiuretic hormone secretion ( 5.9 ). • Sexual Dysfunction: Citalopram tablets may cause symptoms of sexual dysfunction. ( 5.10 ). 5.1 Suicidal Thoughts and Behavior in Adolescents and Young Adults In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients, and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied. There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1,000 patients treated are provided in Table 1 . Table 1:...

warnings and cautions table

Age Range* Drug-Placebo Difference in Number of Patients with Suicidal Thoughts or Behaviors per 1,000 Patients Treated Increases Compared to Placebo<18 years old 14 additional patients18 to 24 years old 5 additional patients Decreases Compared to Placebo25 to 64 years old 1 fewer patient≥65 years old 6 fewer patients

Adverse reactions cross-check#

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adverse reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • Hypersensitivity reactions [see Contraindications ( 4 )] • Suicidal thoughts and behaviors in adolescents and young adults [see Warnings and Precautions ( 5.1 )] • QT-prolongation and torsade de pointes [see Warnings and Precautions ( 5.2 )] • Serotonin syndrome [see Warnings and Precautions ( 5.3 )] • Increased risk of bleeding [see Warnings and Precautions ( 5.4 )] • Activation of mania or hypomania [see Warnings and Precautions ( 5.5 )] • Discontinuation syndrome [see Warnings and Precautions ( 5.6 )] • Seizures [see Warnings and Precautions ( 5.7 )] • Angle-closure glaucoma [see Warnings and Precautions ( 5.8 )] • Hyponatremia [see Warnings and Precautions ( 5.9 )] • Sexual Dysfunction [see Warnings and Precautions ( 5.10 )] Most common adverse reaction (incidence ≥ 5% and twice placebo) is ejaculation disorder (primarily ejaculation delay) ( 6.1 ) . To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc . at 1-800-912-9561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. The safety for citalopram tablets included citalopram exposures in patients and/or healthy subjects from 3 different groups of studies: 429 healthy subjects in clinical pharmacology/pharmacokinetic studies; 4,422 exposures from patients in controlled and uncontrolled clinical trials, corresponding to approximately 1,370 patient-exposure years. There were, in addition, over 19,000 exposures from mostly open-label, European postmarketing studies. The conditions and duration of treatment with citalopram tablets varied greatly and included (in overlapping categories) open-label and double-blind studies, inpatient and outpatient studies, fixed-dose and dose-titration studies, and short-term and long-term exposure. Adverse Reactions Associated with Discontinuation of Treatment Among 1,063 patients with MDD who received citalopram tablets at doses ranging from 10 mg to 80 mg once daily in placebo- controlled trials of up to 6 weeks duration, 16% discontinued tr...

adverse reactions table

Body System/Adverse Reaction Citalopram Placebo (N=1,063) % (N=446) %GeneralAsthenia 1 <1Gastrointestinal DisordersNausea 4 0Dry Mouth 1 <1Vomiting 1 0Central and Peripheral Nervous System DisordersDizziness 2 <1Psychiatric DisordersInsomnia 3 1Somnolence 2 1Agitation 1 <1

Additional Listing Data#

Finished product: Yes
Brand name base: Citalopram
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CITALOPRAM HYDROBROMIDE	20 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	I1E9D14F36
Rxcui	200371, 283672, 309314

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	SPL version
13668-010-01	Citalopram	100 in 1 BOTTLE	TABLET, FILM COATED	100	23
13668-010-05	Citalopram	500 in 1 BOTTLE	TABLET, FILM COATED	500	23
13668-010-06	Citalopram	5600 in 1 BOTTLE	TABLET, FILM COATED	5600	23
13668-010-30	Citalopram	30 in 1 BOTTLE	TABLET, FILM COATED	30	23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13668-010-01	EA - Each	13668-010	87331ea6-81da-4476-950c-8df61edbad10	1	2012-07-24
13668-010-05	EA - Each	13668-010	508a0980-061a-449d-b94b-1876955b0df5	1	2012-07-24
13668-010-06	EA - Each	13668-010	dbb9dc1e-82c6-4af4-b141-10251e20b20d	1	2012-07-24
13668-010-30	EA - Each	13668-010	e2145b49-9edc-448a-b929-da01316372d6	1	2012-07-24
13668-010-74	EA - Each	13668-010	1f1b1f43-4418-47de-bf16-b9400da72869	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 [MAJOR PHARMACEUTICALS]	10
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	CITALOPRAM HYDROBROMIDE TABLET [MAJOR PHARMACEUTICALS]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CITALOPRAM HYDROBROMIDE TABLET [MAJOR PHARMACEUTICALS]	10
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	CITALOPRAM HYDROBROMIDE TABLET [MAJOR PHARMACEUTICALS]	10
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CITALOPRAM HYDROBROMIDE TABLET [MAJOR PHARMACEUTICALS]	10
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CITALOPRAM HYDROBROMIDE TABLET [MAJOR PHARMACEUTICALS]	10
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CITALOPRAM HYDROBROMIDE TABLET [MAJOR PHARMACEUTICALS]	10
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CITALOPRAM HYDROBROMIDE TABLET [MAJOR PHARMACEUTICALS]	10
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CITALOPRAM HYDROBROMIDE TABLET [MAJOR PHARMACEUTICALS]	10
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CITALOPRAM HYDROBROMIDE TABLET [MAJOR PHARMACEUTICALS]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CITALOPRAM HYDROBROMIDE TABLET [MAJOR PHARMACEUTICALS]	10
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CITALOPRAM HYDROBROMIDE TABLET [MAJOR PHARMACEUTICALS]	10
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CITALOPRAM HYDROBROMIDE TABLET [MAJOR PHARMACEUTICALS]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CITALOPRAM HYDROBROMIDE TABLET [MAJOR PHARMACEUTICALS]	10
CITALOPRAM HYDROBROMIDE	ACTIVE INGREDIENT	I1E9D14F36	CITALOPRAM HYDROBROMIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	8
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	CITALOPRAM HYDROBROMIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	8
CITALOPRAM HYDROBROMIDE	ACTIVE INGREDIENT	I1E9D14F36	CITALOPRAM HYDROBROMIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	4
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	CITALOPRAM HYDROBROMIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	4
CITALOPRAM HYDROBROMIDE	ACTIVE INGREDIENT	I1E9D14F36	CITALOPRAM HYDROBROMIDE TABLET [PROFICIENT RX LP]	2
CITALOPRAM HYDROBROMIDE	ACTIVE INGREDIENT	I1E9D14F36	DIRECT RX (CITALOPRAM) TABLET [DIRECT RX]	2
CITALOPRAM HYDROBROMIDE	ACTIVE INGREDIENT	I1E9D14F36	CITALOPRAM HYDROBROMIDE TABLET [TYA PHARMACEUTICALS]	2
CITALOPRAM HYDROBROMIDE	ACTIVE INGREDIENT	I1E9D14F36	CITALOPRAM HYDROBROMIDE TABLET [STAT RX USA]	2
CITALOPRAM HYDROBROMIDE	ACTIVE INGREDIENT	I1E9D14F36	CITALOPRAM HYDROBROMIDE TABLET [UNIT DOSE SERVICES]	2
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	CITALOPRAM HYDROBROMIDE TABLET [PROFICIENT RX LP]	2
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	DIRECT RX (CITALOPRAM) TABLET [DIRECT RX]	2
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	CITALOPRAM HYDROBROMIDE TABLET [STAT RX USA]	2
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	CITALOPRAM HYDROBROMIDE TABLET [UNIT DOSE SERVICES]	2
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	CITALOPRAM HYDROBROMIDE TABLET [TYA PHARMACEUTICALS]	2
CITALOPRAM HYDROBROMIDE	ACTIVE INGREDIENT	I1E9D14F36	CITALOPRAM HYDROBROMIDE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
CITALOPRAM HYDROBROMIDE	ACTIVE INGREDIENT	I1E9D14F36	CITALOPRAM HYDROBROMIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CITALOPRAM HYDROBROMIDE	ACTIVE INGREDIENT	I1E9D14F36	CITALOPRAM HYDROBROMIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1
CITALOPRAM HYDROBROMIDE	ACTIVE INGREDIENT	I1E9D14F36	CITALOPRAM HYDROBROMIDE TABLET [ST MARYS MEDICAL PARK PHARMACY]	1
CITALOPRAM HYDROBROMIDE	ACTIVE INGREDIENT	I1E9D14F36	CITALOPRAM HYDROBROMIDE TABLET [MEDVANTX, INC.]	1
CITALOPRAM HYDROBROMIDE	ACTIVE INGREDIENT	I1E9D14F36	CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]	1
CITALOPRAM HYDROBROMIDE	ACTIVE INGREDIENT	I1E9D14F36	CITALOPRAM HYDROBROMIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
CITALOPRAM HYDROBROMIDE	ACTIVE INGREDIENT	I1E9D14F36	CITALOPRAM HYDROBROMIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	CITALOPRAM HYDROBROMIDE TABLET [MEDVANTX, INC.]	1
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	CITALOPRAM HYDROBROMIDE TABLET [ST MARYS MEDICAL PARK PHARMACY]	1
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	CITALOPRAM HYDROBROMIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	CITALOPRAM HYDROBROMIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	CITALOPRAM HYDROBROMIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	CITALOPRAM HYDROBROMIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]	1
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	CITALOPRAM HYDROBROMIDE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]	1
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13668-010	CITALOPRAM TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]	22	Current NDC, Legacy NDC, 4 package rows	20250125_04766f1d-7a69-49ed-8fd3-1a6305505d47.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
I1E9D14F36	CITALOPRAM HYDROBROMIDE	59729-32-7	CITALOPRAM HYDROBROMIDE
0DHU5B8D6V	CITALOPRAM	59729-33-8	Citalopram

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
200371	citalopram 20 MG Oral Tablet	PSN	bef27fa1-7876-4ce3-834c-a4855aec66c9	102
200371	citalopram 20 MG Oral Tablet	SCD	bef27fa1-7876-4ce3-834c-a4855aec66c9	102
200371	citalopram 20 MG (as citalopram HBr 24.99 MG) Oral Tablet	SY	bef27fa1-7876-4ce3-834c-a4855aec66c9	102
283672	citalopram 10 MG Oral Tablet	PSN	05421bee-f746-418e-bb9c-ab44a89b567d	32
200371	citalopram 20 MG Oral Tablet	PSN	43785b49-5d1e-4ae9-b2ff-26be910bde7f	32
200371	citalopram 20 MG Oral Tablet	PSN	05421bee-f746-418e-bb9c-ab44a89b567d	32
309314	citalopram 40 MG Oral Tablet	PSN	05421bee-f746-418e-bb9c-ab44a89b567d	32
283672	citalopram 10 MG Oral Tablet	SCD	05421bee-f746-418e-bb9c-ab44a89b567d	32
200371	citalopram 20 MG Oral Tablet	SCD	43785b49-5d1e-4ae9-b2ff-26be910bde7f	32
200371	citalopram 20 MG Oral Tablet	SCD	05421bee-f746-418e-bb9c-ab44a89b567d	32
309314	citalopram 40 MG Oral Tablet	SCD	05421bee-f746-418e-bb9c-ab44a89b567d	32
283672	citalopram 10 MG (as citalopram HBr 12.49 MG) Oral Tablet	SY	05421bee-f746-418e-bb9c-ab44a89b567d	32
200371	citalopram 20 MG (as citalopram HBr 24.99 MG) Oral Tablet	SY	05421bee-f746-418e-bb9c-ab44a89b567d	32
200371	citalopram 20 MG (as citalopram HBr 24.99 MG) Oral Tablet	SY	43785b49-5d1e-4ae9-b2ff-26be910bde7f	32
309314	citalopram 40 MG (as citalopram HBr 49.98 MG) Oral Tablet	SY	05421bee-f746-418e-bb9c-ab44a89b567d	32
200371	citalopram 20 MG Oral Tablet	PSN	8719bd44-36b6-468d-9203-8c53a2645184	25
200371	citalopram 20 MG Oral Tablet	SCD	8719bd44-36b6-468d-9203-8c53a2645184	25
200371	citalopram 20 MG (as citalopram HBr 24.99 MG) Oral Tablet	SY	8719bd44-36b6-468d-9203-8c53a2645184	25
283672	citalopram 10 MG Oral Tablet	PSN	04766f1d-7a69-49ed-8fd3-1a6305505d47	23
283672	citalopram 10 MG Oral Tablet	PSN	a6949652-b15b-435b-9097-2219f398ac05	23
200371	citalopram 20 MG Oral Tablet	PSN	a6949652-b15b-435b-9097-2219f398ac05	23
200371	citalopram 20 MG Oral Tablet	PSN	04766f1d-7a69-49ed-8fd3-1a6305505d47	23
309314	citalopram 40 MG Oral Tablet	PSN	04766f1d-7a69-49ed-8fd3-1a6305505d47	23
283672	citalopram 10 MG Oral Tablet	SCD	04766f1d-7a69-49ed-8fd3-1a6305505d47	23
283672	citalopram 10 MG Oral Tablet	SCD	a6949652-b15b-435b-9097-2219f398ac05	23
200371	citalopram 20 MG Oral Tablet	SCD	04766f1d-7a69-49ed-8fd3-1a6305505d47	23
200371	citalopram 20 MG Oral Tablet	SCD	a6949652-b15b-435b-9097-2219f398ac05	23
309314	citalopram 40 MG Oral Tablet	SCD	04766f1d-7a69-49ed-8fd3-1a6305505d47	23
283672	citalopram 10 MG (as citalopram HBr 12.49 MG) Oral Tablet	SY	04766f1d-7a69-49ed-8fd3-1a6305505d47	23
283672	citalopram 10 MG (as citalopram HBr 12.49 MG) Oral Tablet	SY	a6949652-b15b-435b-9097-2219f398ac05	23
200371	citalopram 20 MG (as citalopram HBr 24.99 MG) Oral Tablet	SY	04766f1d-7a69-49ed-8fd3-1a6305505d47	23
200371	citalopram 20 MG (as citalopram HBr 24.99 MG) Oral Tablet	SY	a6949652-b15b-435b-9097-2219f398ac05	23
309314	citalopram 40 MG (as citalopram HBr 49.98 MG) Oral Tablet	SY	04766f1d-7a69-49ed-8fd3-1a6305505d47	23
283672	citalopram 10 MG Oral Tablet	PSN	b52acd68-fed1-4680-9eaf-b72e7dcba6fb	14
200371	citalopram 20 MG Oral Tablet	PSN	b52acd68-fed1-4680-9eaf-b72e7dcba6fb	14
283672	citalopram 10 MG Oral Tablet	SCD	b52acd68-fed1-4680-9eaf-b72e7dcba6fb	14
200371	citalopram 20 MG Oral Tablet	SCD	b52acd68-fed1-4680-9eaf-b72e7dcba6fb	14
283672	citalopram 10 MG (as citalopram HBr 12.49 MG) Oral Tablet	SY	b52acd68-fed1-4680-9eaf-b72e7dcba6fb	14
200371	citalopram 20 MG (as citalopram HBr 24.99 MG) Oral Tablet	SY	b52acd68-fed1-4680-9eaf-b72e7dcba6fb	14
200371	citalopram 20 MG Oral Tablet	PSN	f35bfd9e-afb6-409d-a804-6073d812609d	9
200371	citalopram 20 MG Oral Tablet	SCD	f35bfd9e-afb6-409d-a804-6073d812609d	9
200371	citalopram 20 MG (as citalopram HBr 24.99 MG) Oral Tablet	SY	f35bfd9e-afb6-409d-a804-6073d812609d	9
283672	citalopram 10 MG Oral Tablet	PSN	1a136cc3-d655-4f3c-8710-2603dc008492	8
283672	citalopram 10 MG Oral Tablet	PSN	8712b9a1-d8ef-4393-94f4-e1ab1fa41916	8
200371	citalopram 20 MG Oral Tablet	PSN	db900453-4777-4142-a236-5d3a6152d0a5	8
200371	citalopram 20 MG Oral Tablet	PSN	8712b9a1-d8ef-4393-94f4-e1ab1fa41916	8
200371	citalopram 20 MG Oral Tablet	PSN	1a136cc3-d655-4f3c-8710-2603dc008492	8
283672	citalopram 10 MG Oral Tablet	SCD	8712b9a1-d8ef-4393-94f4-e1ab1fa41916	8
283672	citalopram 10 MG Oral Tablet	SCD	1a136cc3-d655-4f3c-8710-2603dc008492	8
200371	citalopram 20 MG Oral Tablet	SCD	8712b9a1-d8ef-4393-94f4-e1ab1fa41916	8
200371	citalopram 20 MG Oral Tablet	SCD	db900453-4777-4142-a236-5d3a6152d0a5	8
200371	citalopram 20 MG Oral Tablet	SCD	1a136cc3-d655-4f3c-8710-2603dc008492	8
283672	citalopram 10 MG (as citalopram HBr 12.49 MG) Oral Tablet	SY	8712b9a1-d8ef-4393-94f4-e1ab1fa41916	8
283672	citalopram 10 MG (as citalopram HBr 12.49 MG) Oral Tablet	SY	1a136cc3-d655-4f3c-8710-2603dc008492	8
200371	citalopram 20 MG (as citalopram HBr 24.99 MG) Oral Tablet	SY	1a136cc3-d655-4f3c-8710-2603dc008492	8
200371	citalopram 20 MG (as citalopram HBr 24.99 MG) Oral Tablet	SY	8712b9a1-d8ef-4393-94f4-e1ab1fa41916	8
200371	citalopram 20 MG (as citalopram HBr 24.99 MG) Oral Tablet	SY	db900453-4777-4142-a236-5d3a6152d0a5	8
200371	citalopram 20 MG Oral Tablet	PSN	6eaa0a4a-3c0f-48ea-bbc7-0f7a2d2dd3b0	7
200371	citalopram 20 MG Oral Tablet	PSN	6fc110ba-87e7-404e-9e00-b680f354c7b0	7
200371	citalopram 20 MG Oral Tablet	SCD	6eaa0a4a-3c0f-48ea-bbc7-0f7a2d2dd3b0	7
200371	citalopram 20 MG Oral Tablet	SCD	6fc110ba-87e7-404e-9e00-b680f354c7b0	7
200371	citalopram 20 MG (as citalopram HBr 24.99 MG) Oral Tablet	SY	6eaa0a4a-3c0f-48ea-bbc7-0f7a2d2dd3b0	7
200371	citalopram 20 MG (as citalopram HBr 24.99 MG) Oral Tablet	SY	6fc110ba-87e7-404e-9e00-b680f354c7b0	7
283672	citalopram 10 MG Oral Tablet	PSN	1d629704-0f18-420a-a548-b7489ecf1d3b	6
200371	citalopram 20 MG Oral Tablet	PSN	b3541f26-dc8d-6591-e053-2995a90a23d9	6
200371	citalopram 20 MG Oral Tablet	PSN	1d629704-0f18-420a-a548-b7489ecf1d3b	6
283672	citalopram 10 MG Oral Tablet	SCD	1d629704-0f18-420a-a548-b7489ecf1d3b	6
200371	citalopram 20 MG Oral Tablet	SCD	b3541f26-dc8d-6591-e053-2995a90a23d9	6
200371	citalopram 20 MG Oral Tablet	SCD	1d629704-0f18-420a-a548-b7489ecf1d3b	6
283672	citalopram 10 MG (as citalopram HBr 12.49 MG) Oral Tablet	SY	1d629704-0f18-420a-a548-b7489ecf1d3b	6
200371	citalopram 20 MG (as citalopram HBr 24.99 MG) Oral Tablet	SY	1d629704-0f18-420a-a548-b7489ecf1d3b	6
200371	citalopram 20 MG (as citalopram HBr 24.99 MG) Oral Tablet	SY	b3541f26-dc8d-6591-e053-2995a90a23d9	6
200371	citalopram 20 MG Oral Tablet	PSN	a7ef6ad2-5f22-4ac7-b57a-f498bcb53be1	5
309314	citalopram 40 MG Oral Tablet	PSN	a7ef6ad2-5f22-4ac7-b57a-f498bcb53be1	5
200371	citalopram 20 MG Oral Tablet	SCD	a7ef6ad2-5f22-4ac7-b57a-f498bcb53be1	5
309314	citalopram 40 MG Oral Tablet	SCD	a7ef6ad2-5f22-4ac7-b57a-f498bcb53be1	5
200371	citalopram 20 MG (as citalopram HBr 24.99 MG) Oral Tablet	SY	a7ef6ad2-5f22-4ac7-b57a-f498bcb53be1	5
309314	citalopram 40 MG (as citalopram HBr 49.98 MG) Oral Tablet	SY	a7ef6ad2-5f22-4ac7-b57a-f498bcb53be1	5
200371	citalopram 20 MG Oral Tablet	PSN	579836d8-64ed-de2d-e053-2a91aa0a8392	4
200371	citalopram 20 MG Oral Tablet	PSN	4f45c818-b324-6ca6-e054-00144ff8d46c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13668-010-01	13668001001	100 TABLET, FILM COATED in 1 BOTTLE (13668-010-01)		2007-10-18	0000-00-00	No	No	Current
13668-010-05	13668001005	500 TABLET, FILM COATED in 1 BOTTLE (13668-010-05)		2007-10-18	0000-00-00	No	No	Current
13668-010-06	13668001006	5600 TABLET, FILM COATED in 1 BOTTLE (13668-010-06)		2007-10-18	0000-00-00	No	No	Current
13668-010-30	13668001030	30 TABLET, FILM COATED in 1 BOTTLE (13668-010-30)		2007-10-18	0000-00-00	No	No	Current
13668-010-74	13668001074	100 TABLET in 1 CARTON (13668-010-74)	100 tablet	2007-10-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Citalopram	St. Mary's Medical Park Pharmacy	2026-06-30	HUMAN PRESCRIPTION DRUG LABEL	9
Citalopram	ASCLEMED USA INC. \| ASCLEMED USA INC. DBA ENOVACHEM	2026-05-29	HUMAN PRESCRIPTION DRUG LABEL	1
Citalopram	QPharma, Inc. \| Torrent Pharma, Inc. \| Northwind Health Company, LLC	2026-05-08	HUMAN PRESCRIPTION DRUG LABEL	9
Citalopram	PD-Rx Pharmaceuticals, Inc.	2026-05-05	HUMAN PRESCRIPTION DRUG LABEL	32
Citalopram	REMEDYREPACK INC.	2026-04-24	HUMAN PRESCRIPTION DRUG LABEL	4
Citalopram	Coupler LLC \| Torrent Pharma, Inc.	2026-04-24	HUMAN PRESCRIPTION DRUG LABEL	1
Citalopram	Bryant Ranch Prepack	2026-03-13	HUMAN PRESCRIPTION DRUG LABEL	102
Citalopram	Major Pharmaceuticals	2026-02-18	HUMAN PRESCRIPTION DRUG LABEL	23
Citalopram	Torrent Pharmaceuticals Limited \| Torrent Pharma, Inc. \| Piramal Pharma Limited	2026-02-04	HUMAN PRESCRIPTION DRUG LABEL	23
Citalopram Hydrobromide	Preferred Pharmaceuticals, Inc.	2026-01-26	HUMAN PRESCRIPTION DRUG LABEL	14
Citalopram	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	6
Citalopram	REMEDYREPACK INC.	2025-01-29	HUMAN PRESCRIPTION DRUG LABEL	24
Citalopram Tablets	Advanced Rx of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	6
Citalopram Tablets, USP	NuCare Pharmaceuticals,Inc.	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	2
Citalopram Tablets, USP	Quality Care Products, LLC	2024-12-18	HUMAN PRESCRIPTION DRUG LABEL	7
Citalopram Hydrobromide	Bryant Ranch Prepack	2024-11-08	HUMAN PRESCRIPTION DRUG LABEL	25
Citalopram Tablets, USP	Proficient Rx LP	2024-11-01	HUMAN PRESCRIPTION DRUG LABEL	8
Citalopram Hydrobromide	A-S Medication Solutions	2024-09-18	HUMAN PRESCRIPTION DRUG LABEL	32
Citalopram Hydrobromide	REMEDYREPACK INC.	2024-08-14	HUMAN PRESCRIPTION DRUG LABEL	13
Citalopram Tablets, USP	NuCare Pharmaceuticals, Inc.	2024-07-17	HUMAN PRESCRIPTION DRUG LABEL	4
Citalopram Tablets, USP	NuCare Pharmaceuticals,Inc.	2024-07-11	HUMAN PRESCRIPTION DRUG LABEL	4

Citalopram

Orange Book products#

Therapeutic equivalence codes#

openFDA label cross-check#

Boxed warning cross-check#

boxed warning

Warnings cross-check#

warnings and cautions

warnings and cautions table

Adverse reactions cross-check#

adverse reactions

adverse reactions table

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#