Citalopram

Product NDC
70518-4416
Requested package NDC
70518-4416-0
11-digit product format
705184416
Labeler code
70518
Product ID
70518-4416_3b8bf64b-77c4-de20-e063-6394a90a4c21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078216
Marketing category
ANDA
Marketing start
2025-07-31
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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078216-001CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-27
A078216-002CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2007-03-27
A078216-003CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2007-03-27

Therapeutic equivalence codes#

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

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

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078216-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078216-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2007-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078216-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2007-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078216-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078216-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2007-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078216-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2007-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A078216-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078216-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2007-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078216-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2007-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078216-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078216-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2007-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078216-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2007-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078216-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078216-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2007-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078216-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2007-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078216-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078216-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2007-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078216-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2007-03-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078216-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078216-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2007-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078216-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2007-03-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078216-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078216-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2007-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078216-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2007-03-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078216-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078216-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2007-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078216-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2007-03-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078216-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A078216-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2007-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A078216-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2007-03-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078216-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078216-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2007-03-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078216-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2007-03-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078216-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078216-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2007-03-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078216-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2007-03-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078216-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078216-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2007-03-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078216-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2007-03-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078216-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-278072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078216-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078216-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078216-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078216-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078216-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078216-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078216-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078216-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078216-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078216-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078216-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078216-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078216-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078216-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078216-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078216-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078216-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078216-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078216-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078216-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078216-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078216-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078216-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078216-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078216-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078216-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078216-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078216-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078216-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078216-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078216-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078216-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078216-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078216-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078216-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078216-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078216-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078216-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078216-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078216-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITALOPRAM HYDROBROMIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
I1E9D14F36Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f3237467-286d-480d-8c80-b9a97738edaaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
475812f9-1b2c-4cb0-9e72-1e52f935ae6fProduct name120221114
0b05d650-9b7b-4b36-a6f4-1a850d5a2e64Product name120151228
e61ea6cb-0b08-40a9-a984-7b23201c7aa2Product name120151222

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4416-0Citalopram30 in 1 BLISTER PACKTABLET, FILM COATED301

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CitalopramCITALOPRAMPD-Rx Pharmaceuticals, Inc.9fe40d83-8945-4577-add5-28d52410154e2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMSt. Mary's Medical Park Pharmacydb900453-4777-4142-a236-5d3a6152d0a52026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMCoupler LLC53e5d66f-7902-76ac-e063-6294a90aa5262026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMCoupler LLC53e6d0a4-95d9-9c1a-e063-6294a90a9d182026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMBryant Ranch Prepack9b53c14c-224c-49ed-8a00-96f871593ab02026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMASCLEMED USA INC.df8db06a-ced7-4dd6-83bd-c61d2f68f1b12026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMSt. Mary's Medical Park Pharmacy351ca54b-0eb6-4e93-8ab4-82fb18dcc9e12026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMQPharma, Inc.f35bfd9e-afb6-409d-a804-6073d812609d2026-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMPD-Rx Pharmaceuticals, Inc.43785b49-5d1e-4ae9-b2ff-26be910bde7f2026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMREMEDYREPACK INC.a26772e7-6e4d-489b-bb5e-5bc322ef6dfe2026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMPD-Rx Pharmaceuticals, Inc.df929b3f-0cda-4a75-96d3-22e6b0edbbc92026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMREMEDYREPACK INC.bdc0c228-797a-42dd-8114-aa68c1eb33002026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMCoupler LLC50380ce5-c77f-3ee3-e063-6394a90a17ae2026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMCardinal Health 107, LLC6c8942f8-963a-4007-a147-b77ac629e4d42026-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEPreferred Pharmaceuticals Inc.27ddea53-f03d-4760-99bb-ec8efa44ff622026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMBryant Ranch Prepackbef27fa1-7876-4ce3-834c-a4855aec66c92026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMMajor Pharmaceuticalsa6949652-b15b-435b-9097-2219f398ac052026-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMTorrent Pharmaceuticals Limited04766f1d-7a69-49ed-8fd3-1a6305505d472026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEPreferred Pharmaceuticals, Inc.b52acd68-fed1-4680-9eaf-b72e7dcba6fb2026-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMNorthwind Health Company, LLCa7ef6ad2-5f22-4ac7-b57a-f498bcb53be12026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSNf3237467-286d-480d-8c80-b9a97738edaa1
283672citalopram 10 MG Oral TabletSCDf3237467-286d-480d-8c80-b9a97738edaa1
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSYf3237467-286d-480d-8c80-b9a97738edaa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4416-07051844160030 TABLET, FILM COATED in 1 BLISTER PACK (70518-4416-0) 2025-07-31NoNoCurrent