Citalopram

Product NDC: 0904-6084
11-digit product format: 009046084
Labeler code: 0904
Product ID: 0904-6084_5bf8d853-5669-4ef2-940e-6c9075a45ce9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Citalopram
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA078216
Marketing category: ANDA
Marketing start: 2009-11-02
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: 2027-12-31
Current FDA listing: Yes

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

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	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#

Current TE-code rows page 1 of 1 · 3 matching rows.

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

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 · 123 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	A078216-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078216-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078216-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078216-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078216-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078216-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078216-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078216-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078216-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078216-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078216-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078216-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078216-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078216-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078216-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078216-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078216-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078216-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078216-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078216-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078216-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078216-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078216-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078216-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078216-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078216-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078216-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078216-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078216-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078216-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078216-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078216-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078216-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078216-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078216-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078216-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078216-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078216-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078216-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078216-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A078216-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078216-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078216-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078216-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078216-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078216-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078216-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078216-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078216-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078216-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078216-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078216-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078216-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078216-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078216-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078216-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078216-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078216-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078216-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078216-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078216-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078216-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078216-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078216-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078216-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078216-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078216-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078216-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078216-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078216-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078216-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078216-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078216-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078216-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078216-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078216-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078216-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078216-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078216-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078216-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CITALOPRAM HYDROBROMIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
I1E9D14F36	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
200371	Internal RxNorm lookup
283672	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a6949652-b15b-435b-9097-2219f398ac05	Available on FDA.report

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
0904-6084-61	Citalopram	100 in 1 CARTON	TABLET, FILM COATED	100		23
0904-6084-61	Citalopram	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6084-61	EA - Each	0904-6084	1f6b2593-d712-4de6-8ded-318159de355d	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 [CARDINAL HEALTH]	15
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	CITALOPRAM HYDROBROMIDE TABLET [CARDINAL HEALTH]	15
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CITALOPRAM HYDROBROMIDE TABLET [CARDINAL HEALTH]	15
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	CITALOPRAM HYDROBROMIDE TABLET [CARDINAL HEALTH]	15
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CITALOPRAM HYDROBROMIDE TABLET [CARDINAL HEALTH]	15
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CITALOPRAM HYDROBROMIDE TABLET [CARDINAL HEALTH]	15
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CITALOPRAM HYDROBROMIDE TABLET [CARDINAL HEALTH]	15
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CITALOPRAM HYDROBROMIDE TABLET [CARDINAL HEALTH]	15
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CITALOPRAM HYDROBROMIDE TABLET [CARDINAL HEALTH]	15
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CITALOPRAM HYDROBROMIDE TABLET [CARDINAL HEALTH]	15
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CITALOPRAM HYDROBROMIDE TABLET [CARDINAL HEALTH]	15
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CITALOPRAM HYDROBROMIDE TABLET [CARDINAL HEALTH]	15
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CITALOPRAM HYDROBROMIDE TABLET [CARDINAL HEALTH]	15
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CITALOPRAM HYDROBROMIDE TABLET [CARDINAL HEALTH]	15
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6084	CITALOPRAM TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	21	Current NDC, Legacy NDC, 2 package rows	20250227_a6949652-b15b-435b-9097-2219f398ac05.zip

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 2 · 39 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Citalopram	CITALOPRAM	PD-Rx Pharmaceuticals, Inc.	9fe40d83-8945-4577-add5-28d52410154e	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	St. Mary's Medical Park Pharmacy	db900453-4777-4142-a236-5d3a6152d0a5	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	Coupler LLC	53e5d66f-7902-76ac-e063-6294a90aa526	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	Coupler LLC	53e6d0a4-95d9-9c1a-e063-6294a90a9d18	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	Bryant Ranch Prepack	9b53c14c-224c-49ed-8a00-96f871593ab0	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	ASCLEMED USA INC.	df8db06a-ced7-4dd6-83bd-c61d2f68f1b1	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	St. Mary's Medical Park Pharmacy	351ca54b-0eb6-4e93-8ab4-82fb18dcc9e1	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	QPharma, Inc.	f35bfd9e-afb6-409d-a804-6073d812609d	2026-05-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	PD-Rx Pharmaceuticals, Inc.	43785b49-5d1e-4ae9-b2ff-26be910bde7f	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	REMEDYREPACK INC.	a26772e7-6e4d-489b-bb5e-5bc322ef6dfe	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	PD-Rx Pharmaceuticals, Inc.	df929b3f-0cda-4a75-96d3-22e6b0edbbc9	2026-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	REMEDYREPACK INC.	bdc0c228-797a-42dd-8114-aa68c1eb3300	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	Coupler LLC	50380ce5-c77f-3ee3-e063-6394a90a17ae	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	Cardinal Health 107, LLC	6c8942f8-963a-4007-a147-b77ac629e4d4	2026-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Preferred Pharmaceuticals Inc.	27ddea53-f03d-4760-99bb-ec8efa44ff62	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	Bryant Ranch Prepack	bef27fa1-7876-4ce3-834c-a4855aec66c9	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	Major Pharmaceuticals	a6949652-b15b-435b-9097-2219f398ac05	2026-02-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216 ndc (product): 0904-6084
Citalopram	CITALOPRAM	Torrent Pharmaceuticals Limited	04766f1d-7a69-49ed-8fd3-1a6305505d47	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Preferred Pharmaceuticals, Inc.	b52acd68-fed1-4680-9eaf-b72e7dcba6fb	2026-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	Northwind Health Company, LLC	a7ef6ad2-5f22-4ac7-b57a-f498bcb53be1	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216

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
283672	citalopram 10 MG Oral Tablet	PSN	6c8942f8-963a-4007-a147-b77ac629e4d4	32
200371	citalopram 20 MG Oral Tablet	PSN	6c8942f8-963a-4007-a147-b77ac629e4d4	32
283672	citalopram 10 MG Oral Tablet	SCD	6c8942f8-963a-4007-a147-b77ac629e4d4	32
200371	citalopram 20 MG Oral Tablet	SCD	6c8942f8-963a-4007-a147-b77ac629e4d4	32
283672	citalopram 10 MG (as citalopram HBr 12.49 MG) Oral Tablet	SY	6c8942f8-963a-4007-a147-b77ac629e4d4	32
200371	citalopram 20 MG (as citalopram HBr 24.99 MG) Oral Tablet	SY	6c8942f8-963a-4007-a147-b77ac629e4d4	32
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
283672	citalopram 10 MG Oral Tablet	SCD	a6949652-b15b-435b-9097-2219f398ac05	23
200371	citalopram 20 MG Oral Tablet	SCD	a6949652-b15b-435b-9097-2219f398ac05	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	a6949652-b15b-435b-9097-2219f398ac05	23

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6084-61	00904608461	100 BLISTER PACK in 1 CARTON (0904-6084-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK	100 blister pack	2009-11-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Citalopram	Cardinal Health 107, LLC	2026-04-17	HUMAN PRESCRIPTION DRUG LABEL	32
Citalopram	Major Pharmaceuticals	2026-02-18	HUMAN PRESCRIPTION DRUG LABEL	23