FDA.reportPublic FDA data

CITALOPRAM

Product NDC
60429-175
Requested package NDC
60429-175-01
11-digit product format
604290175
Labeler code
60429
Product ID
60429-175_2bb26393-e61c-3ff0-e063-6394a90aea5e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
citalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA077045
Marketing category
ANDA
Marketing start
2005-04-29
Substance
CITALOPRAM HYDROBROMIDE
Active strength
40 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 packagepackage60429-17560429-175-01DDiscontinued by firm2026-07-31

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A077045-001CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2005-04-29a50c72e98297…
2026-08-01 22:54:322026-06A077045-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2005-04-29a50c72e98297…
2026-08-01 22:54:322026-06A077045-003CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2005-04-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077045-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A077045-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A077045-003AB1a50c72e98297…

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
ndc (package): 60429-175-01
ndc (product): 60429-175
ndc11 (package): 60429017501
CITALOPRAMCITALOPRAMEpic Pharma, LLC08b6d5da-5919-4760-9e16-3b478a14d6d72024-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077045
application number: ANDA077045
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 HYDROBROMIDE40 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
f3a26d92-b662-4896-82eb-261948042408Available 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
60429-175-01CITALOPRAM100 in 1 BOTTLETABLET, FILM COATED10013
60429-175-10CITALOPRAM1000 in 1 BOTTLETABLET, FILM COATED100013
60429-175-30CITALOPRAM30 in 1 BOTTLETABLET, FILM COATED3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-175-01EA - Each60429-1753c1cbe06-cca6-41df-9961-7fa96621b65912012-07-24
60429-175-10EA - Each60429-1754c330cd1-8a28-4018-bb1a-7f4d4aa569ac12012-07-24
60429-175-30EA - Each60429-175cda56978-c811-4c71-997c-fe11ccc7270212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
60429-175CITALOPRAM TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]13Current NDC, Legacy NDC, 3 package rows20250119_f3a26d92-b662-4896-82eb-261948042408.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
309314citalopram 40 MG Oral TabletPSN3d70380f-ef97-4de9-a8f8-44ef9ba7e5a71
309314citalopram 40 MG Oral TabletSCD3d70380f-ef97-4de9-a8f8-44ef9ba7e5a71
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY3d70380f-ef97-4de9-a8f8-44ef9ba7e5a71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60429-175-0160429017501100 TABLET, FILM COATED in 1 BOTTLE (60429-175-01) 2011-05-200000-00-00NoNoCurrent