Citalopram

Product NDC
70518-4335
11-digit product format
705184335
Labeler code
70518
Product ID
70518-4335_50378d1d-871a-8e1c-e063-6394a90a3897
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078216
Marketing category
ANDA
Marketing start
2025-05-01
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

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-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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078216-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A078216-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2007-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A078216-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2007-03-2784e616aacf4f…
2026-08-18 06:07:402026-07A078216-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A078216-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2007-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A078216-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2007-03-27caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A078216-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078216-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A078216-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A078216-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078216-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078216-003AB1caaa826d4ba7…
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…

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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITALOPRAM HYDROBROMIDE20 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
200371Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bdc0c228-797a-42dd-8114-aa68c1eb3300Available 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
70518-4335-0Citalopram30 in 1 BLISTER PACKTABLET, FILM COATED304
70518-4335-1Citalopram90 in 1 BOTTLE, PLASTICTABLET, FILM COATED904
70518-4335-2Citalopram30 in 1 BLISTER PACKTABLET, FILM COATED304
70518-4335-3Citalopram50 in 1 BOXTABLET, FILM COATED504
70518-4335-4Citalopram1 in 1 POUCHTABLET, FILM COATED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4335CITALOPRAM TABLET, FILM COATED [REMEDYREPACK INC.]1Current NDC, 5 package rows20250503_bdc0c228-797a-42dd-8114-aa68c1eb3300.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 2 of 2 · 38 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Citalopram HydrobromideCITALOPRAM HYDROBROMIDENorthwind Health Company, LLCc133fc77-6c8a-d2b1-e053-2995a90ab5f72025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMAdvanced Rx of Tennessee, LLC434094b4-fa3b-385a-e063-6394a90ac6382025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDENuCare Pharmaceuticals,Inc.c577b306-ee7c-8364-e053-2a95a90abb132025-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDENuCare Pharmaceuticals,Inc.c584909b-e7b2-7108-e053-2995a90a2f542024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMAdvanced Rx of Tennessee, LLCb3541f26-dc8d-6591-e053-2995a90a23d92024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEQuality Care Products, LLC6fc110ba-87e7-404e-9e00-b680f354c7b02024-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEQuality Care Products, LLCe22fe468-5d9e-4ec7-a69b-4988e0b8acbd2024-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEBryant Ranch Prepack8719bd44-36b6-468d-9203-8c53a26451842024-11-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEProficient Rx LP1a136cc3-d655-4f3c-8710-2603dc0084922024-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEBryant Ranch Prepack15cb00da-4435-4930-90d0-faadf2739a5c2024-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEA-S Medication Solutions05421bee-f746-418e-bb9c-ab44a89b567d2024-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDENuCare Pharmaceuticals, Inc.4f45c818-b324-6ca6-e054-00144ff8d46c2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDENuCare Pharmaceuticals,Inc.579836d8-64ed-de2d-e053-2a91aa0a83922024-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDENuCare Pharmaceuticals,Inc.549a5b3f-4928-1ae5-e054-00144ff8d46c2024-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDENuCare Pharmaceuticals,Inc.9987a273-e6d7-54cd-e053-2a95a90a0aaa2024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEA-S Medication Solutions9059c8f1-8755-492d-aba2-5f5088ce69d32023-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEA-S Medication Solutions9d2f8f9f-9710-48e0-bc18-105a2af1073b2023-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEProficient Rx LP4eb71151-241a-476e-a495-4a021bc55bda2023-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200371citalopram 20 MG Oral TabletPSNbdc0c228-797a-42dd-8114-aa68c1eb33004
200371citalopram 20 MG Oral TabletSCDbdc0c228-797a-42dd-8114-aa68c1eb33004
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSYbdc0c228-797a-42dd-8114-aa68c1eb33004

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4335-07051843350030 TABLET, FILM COATED in 1 BLISTER PACK (70518-4335-0) 2025-05-01NoNoCurrent
70518-4335-17051843350190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4335-1) 2025-06-01NoNoCurrent
70518-4335-27051843350230 TABLET, FILM COATED in 1 BLISTER PACK (70518-4335-2) 2025-06-13NoNoCurrent
70518-4335-37051843350350 POUCH in 1 BOX (70518-4335-3) / 1 TABLET, FILM COATED in 1 POUCH (70518-4335-4) 50 pouch2026-04-24NoNoCurrent
70518-4335-4705184335041 in 1 POUCHHistorical