CITALOPRAM

Product NDC
42806-019
11-digit product format
428060019
Labeler code
42806
Product ID
42806-019_b7f54932-2c8c-44f4-acc6-d9e2b3914be9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
citalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA077045
Marketing category
ANDA
Marketing start
2011-05-20
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage42806-01942806-019-05DDiscontinued by firm2026-08-03

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
A077045-001CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2005-04-29
A077045-002CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2005-04-29
A077045-003CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2005-04-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077045-001AB
A077045-002AB
A077045-003AB

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 UTC2026-02A077045-001CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2005-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077045-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2005-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077045-003CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2005-04-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077045-001CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2005-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077045-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2005-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077045-003CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2005-04-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A077045-001CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2005-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077045-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2005-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077045-003CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2005-04-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077045-001CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2005-04-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077045-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2005-04-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077045-003CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2005-04-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077045-001CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2005-04-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077045-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2005-04-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077045-003CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2005-04-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077045-001CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2005-04-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077045-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2005-04-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077045-003CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2005-04-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077045-001CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2005-04-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077045-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2005-04-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077045-003CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2005-04-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077045-001CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2005-04-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077045-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2005-04-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077045-003CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2005-04-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077045-001CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2005-04-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077045-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2005-04-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077045-003CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2005-04-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077045-001CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2005-04-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A077045-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2005-04-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A077045-003CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2005-04-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077045-001CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2005-04-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077045-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2005-04-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077045-003CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2005-04-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077045-001CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2005-04-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077045-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2005-04-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077045-003CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2005-04-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077045-001CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2005-04-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077045-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2005-04-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077045-003CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2005-04-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077045-001CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2005-04-298072bd15b7f6…

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 UTC2026-02A077045-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077045-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077045-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077045-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077045-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077045-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077045-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077045-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077045-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077045-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077045-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077045-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077045-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077045-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077045-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077045-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077045-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077045-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077045-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077045-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077045-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077045-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077045-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077045-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077045-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077045-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077045-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077045-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077045-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077045-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077045-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077045-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077045-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077045-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077045-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077045-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077045-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077045-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077045-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077045-001AB18072bd15b7f6…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CITALOPRAMCITALOPRAMGolden State Medical Supply, Inc.f3a26d92-b662-4896-82eb-2619480424082025-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077045
application number: ANDA077045
CITALOPRAMCITALOPRAMEpic Pharma, LLC08b6d5da-5919-4760-9e16-3b478a14d6d72024-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077045
application number: ANDA077045
ndc (product): 42806-019
CitalopramCITALOPRAMAphena Pharma Solutions - Tennessee, LLC3d70380f-ef97-4de9-a8f8-44ef9ba7e5a72020-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077045
application number: ANDA077045

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
200371Internal RxNorm lookup
283672Internal RxNorm lookup
309314Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
08b6d5da-5919-4760-9e16-3b478a14d6d7Available 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
42806-019-01CITALOPRAM100 in 1 BOTTLETABLET, FILM COATED10015
42806-019-05CITALOPRAM500 in 1 BOTTLETABLET, FILM COATED50015
42806-019-10CITALOPRAM1000 in 1 BOTTLETABLET, FILM COATED100015
42806-019-30CITALOPRAM30 in 1 BOTTLETABLET, FILM COATED3015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-019-01EA - Each42806-0196ab0f166-6d1e-49db-b845-6b5f7c0e331c12012-07-24
42806-019-10EA - Each42806-01992d69b7b-51c2-4243-80a2-ff93d13e274512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC]7
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC]7
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC]7
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KCITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC]7
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC]7
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC]7
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-019CITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC]15Current NDC, Legacy NDC, 4 package rows20241222_08b6d5da-5919-4760-9e16-3b478a14d6d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSN08b6d5da-5919-4760-9e16-3b478a14d6d715
200371citalopram 20 MG Oral TabletPSN08b6d5da-5919-4760-9e16-3b478a14d6d715
309314citalopram 40 MG Oral TabletPSN08b6d5da-5919-4760-9e16-3b478a14d6d715
283672citalopram 10 MG Oral TabletSCD08b6d5da-5919-4760-9e16-3b478a14d6d715
200371citalopram 20 MG Oral TabletSCD08b6d5da-5919-4760-9e16-3b478a14d6d715
309314citalopram 40 MG Oral TabletSCD08b6d5da-5919-4760-9e16-3b478a14d6d715
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY08b6d5da-5919-4760-9e16-3b478a14d6d715
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY08b6d5da-5919-4760-9e16-3b478a14d6d715
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY08b6d5da-5919-4760-9e16-3b478a14d6d715
283672citalopram 10 MG Oral TabletPSNf3a26d92-b662-4896-82eb-26194804240813
200371citalopram 20 MG Oral TabletPSNf3a26d92-b662-4896-82eb-26194804240813
309314citalopram 40 MG Oral TabletPSNf3a26d92-b662-4896-82eb-26194804240813
283672citalopram 10 MG Oral TabletSCDf3a26d92-b662-4896-82eb-26194804240813
200371citalopram 20 MG Oral TabletSCDf3a26d92-b662-4896-82eb-26194804240813
309314citalopram 40 MG Oral TabletSCDf3a26d92-b662-4896-82eb-26194804240813
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSYf3a26d92-b662-4896-82eb-26194804240813
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSYf3a26d92-b662-4896-82eb-26194804240813
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSYf3a26d92-b662-4896-82eb-26194804240813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42806-019-0142806001901100 TABLET, FILM COATED in 1 BOTTLE (42806-019-01) 2011-05-200000-00-00NoNoCurrent
42806-019-0542806001905500 in 1 BOTTLEHistorical
42806-019-10428060019101000 TABLET, FILM COATED in 1 BOTTLE (42806-019-10) 2011-05-200000-00-00NoNoCurrent
42806-019-304280600193030 TABLET, FILM COATED in 1 BOTTLE (42806-019-30) 2011-05-200000-00-00NoNoCurrent