Citalopram

Product NDC: 70518-2553
Requested package NDC: 70518-2553-0
11-digit product format: 705182553
Labeler code: 70518
Product ID: 70518-2553_4a67aedb-35d4-e009-e063-6394a90a467c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: citalopram
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA077042
Marketing category: ANDA
Marketing start: 2020-01-22
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

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	70518-2553	70518-2553-0	D	Discontinued by firm		2026-08-11

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 · 10 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`

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
A077042-001	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-11-05
A077042-002	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-11-05
A077042-003	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-11-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077042-001	AB
A077042-002	AB
A077042-003	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	A077042-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077042-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077042-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077042-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077042-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077042-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077042-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077042-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077042-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077042-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077042-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077042-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077042-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077042-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077042-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077042-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077042-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077042-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077042-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077042-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077042-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077042-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077042-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077042-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077042-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077042-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077042-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077042-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-11-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077042-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-11-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077042-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077042-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-11-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077042-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-11-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077042-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077042-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-11-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077042-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-11-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077042-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077042-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-11-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077042-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-11-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077042-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077042-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-11-05	`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	A077042-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077042-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077042-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077042-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077042-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077042-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077042-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077042-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077042-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077042-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077042-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077042-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077042-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077042-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077042-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077042-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077042-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077042-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077042-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077042-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077042-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077042-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077042-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077042-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077042-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077042-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077042-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077042-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077042-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077042-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077042-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077042-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077042-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077042-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077042-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077042-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077042-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077042-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077042-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077042-001	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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
f79f878e-99fb-4757-8abb-931af1fa9e2b	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
70518-2553-0	Citalopram	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90		10
70518-2553-1	Citalopram	30 in 1 BLISTER PACK	TABLET, FILM COATED	30		10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-2553	CITALOPRAM TABLET, FILM COATED [REMEDYREPACK INC.]	8	Current NDC, Legacy NDC, 2 package rows	20250202_f79f878e-99fb-4757-8abb-931af1fa9e2b.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 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Citalopram	CITALOPRAM	REMEDYREPACK INC.	f79f878e-99fb-4757-8abb-931af1fa9e2b	2026-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077042 application number: ANDA077042 ndc (package): 70518-2553-0 ndc (product): 70518-2553 ndc11 (package): 70518255300
Citalopram	CITALOPRAM	REMEDYREPACK INC.	aa9c1440-354f-43a6-9e70-fd7bafcb03c5	2026-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077042 application number: ANDA077042
Citalopram	CITALOPRAM	Bryant Ranch Prepack	2a8acad8-0ba0-4631-9f6d-f587e7a8558c	2024-10-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077042 application number: ANDA077042
Citalopram	CITALOPRAM	Mylan Pharmaceuticals Inc.	825c0c49-5fbf-6d8b-cb8c-94ebf0eda043	2024-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077042 application number: ANDA077042
Citalopram	CITALOPRAM	NuCare Pharmaceuticals,Inc.	0dfb11d9-f48d-56ee-e063-6294a90ad256	2024-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077042 application number: ANDA077042

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	f79f878e-99fb-4757-8abb-931af1fa9e2b	10
283672	citalopram 10 MG Oral Tablet	SCD	f79f878e-99fb-4757-8abb-931af1fa9e2b	10
283672	citalopram 10 MG (as citalopram HBr 12.49 MG) Oral Tablet	SY	f79f878e-99fb-4757-8abb-931af1fa9e2b	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2553-0	70518255300	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2553-0)	2020-01-22	0000-00-00	No	No	Current