Citalopram

Product NDC: 80425-0557
11-digit product format: 804250557
Labeler code: 80425
Product ID: 80425-0557_43408cc0-4400-3827-e063-6394a90adcfe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Citalopram
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Advanced Rx of Tennessee, LLC
Application: ANDA078216
Marketing category: ANDA
Marketing start: 2025-11-07
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: 2026-12-31
Current FDA listing: Yes

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	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 · 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	A078216-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078216-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078216-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078216-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078216-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078216-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-27	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078216-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078216-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078216-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078216-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078216-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078216-003	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Citalopram
Listing expiration: 2026-12-31

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
434094b4-fa3b-385a-e063-6394a90ac638	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	SPL version
80425-0557-1	Citalopram	30 in 1 BOTTLE	TABLET, FILM COATED	30	1
80425-0557-2	Citalopram	60 in 1 BOTTLE	TABLET, FILM COATED	60	1
80425-0557-3	Citalopram	90 in 1 BOTTLE	TABLET, FILM COATED	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0557-1	EA - Each	80425-0557	76650329-c6a2-4271-832c-c000176eedf7	1	2025-12-16
80425-0557-2	EA - Each	80425-0557	480a3215-4366-4d78-ac5c-60b62131d279	1	2025-12-16
80425-0557-3	EA - Each	80425-0557	84caa3c3-474f-4729-bfe1-ce72215ff89f	1	2025-12-16

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 2 of 2 · 38 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Northwind Health Company, LLC	c133fc77-6c8a-d2b1-e053-2995a90ab5f7	2025-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	Advanced Rx of Tennessee, LLC	434094b4-fa3b-385a-e063-6394a90ac638	2025-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216 ndc (product): 80425-0557
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	NuCare Pharmaceuticals,Inc.	c577b306-ee7c-8364-e053-2a95a90abb13	2025-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	NuCare Pharmaceuticals,Inc.	c584909b-e7b2-7108-e053-2995a90a2f54	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	Advanced Rx of Tennessee, LLC	b3541f26-dc8d-6591-e053-2995a90a23d9	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Quality Care Products, LLC	6fc110ba-87e7-404e-9e00-b680f354c7b0	2024-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Quality Care Products, LLC	e22fe468-5d9e-4ec7-a69b-4988e0b8acbd	2024-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Bryant Ranch Prepack	8719bd44-36b6-468d-9203-8c53a2645184	2024-11-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Proficient Rx LP	1a136cc3-d655-4f3c-8710-2603dc008492	2024-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Bryant Ranch Prepack	15cb00da-4435-4930-90d0-faadf2739a5c	2024-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	A-S Medication Solutions	05421bee-f746-418e-bb9c-ab44a89b567d	2024-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	NuCare Pharmaceuticals, Inc.	4f45c818-b324-6ca6-e054-00144ff8d46c	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	NuCare Pharmaceuticals,Inc.	579836d8-64ed-de2d-e053-2a91aa0a8392	2024-07-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	NuCare Pharmaceuticals,Inc.	549a5b3f-4928-1ae5-e054-00144ff8d46c	2024-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	NuCare Pharmaceuticals,Inc.	9987a273-e6d7-54cd-e053-2a95a90a0aaa	2024-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	A-S Medication Solutions	9059c8f1-8755-492d-aba2-5f5088ce69d3	2023-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	A-S Medication Solutions	9d2f8f9f-9710-48e0-bc18-105a2af1073b	2023-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Proficient Rx LP	4eb71151-241a-476e-a495-4a021bc55bda	2023-02-01	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	434094b4-fa3b-385a-e063-6394a90ac638	1
283672	citalopram 10 MG Oral Tablet	SCD	434094b4-fa3b-385a-e063-6394a90ac638	1
283672	citalopram 10 MG (as citalopram HBr 12.49 MG) Oral Tablet	SY	434094b4-fa3b-385a-e063-6394a90ac638	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
80425-0557-1	80425055701	30 TABLET, FILM COATED in 1 BOTTLE (80425-0557-1)	2025-11-07	No	No	Current
80425-0557-2	80425055702	60 TABLET, FILM COATED in 1 BOTTLE (80425-0557-2)	2025-11-07	No	No	Current
80425-0557-3	80425055703	90 TABLET, FILM COATED in 1 BOTTLE (80425-0557-3)	2025-11-07	No	No	Current