FDA.reportPublic FDA data

CITALOPRAM

Product NDC
59651-964
11-digit product format
596510964
Labeler code
59651
Product ID
59651-964_80af8ae8-c106-4895-bab3-0579b41f1e75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CITALOPRAM
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA219985
Marketing category
ANDA
Marketing start
2026-03-13
Substance
CITALOPRAM HYDROBROMIDE
Active strength
30 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 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219985-001CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 30MG BASECAPSULE / ORALAB2026-03-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219985-001AB

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
A219985-001CGT2026-09-16

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
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219985-001CITALOPRAM HYDROBROMIDEEQ 30MG BASECAPSULE / ORALAB2026-03-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219985-001AB1a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219985-001CGT2026-09-16a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
CITALOPRAM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITALOPRAM HYDROBROMIDE30 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
2591786Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
80af8ae8-c106-4895-bab3-0579b41f1e75Available 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
59651-964-30CITALOPRAM30 in 1 BOTTLECAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-964-30EA - Each59651-96463d3ca78-b2c1-4431-b145-6ac39418011812026-04-20

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CITALOPRAMCITALOPRAMAurobindo Pharma Limited80af8ae8-c106-4895-bab3-0579b41f1e752026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219985
application number: ANDA219985
ndc (product): 59651-964

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2591786citalopram 30 MG Oral CapsulePSN80af8ae8-c106-4895-bab3-0579b41f1e751
2591786citalopram 30 MG Oral CapsuleSCD80af8ae8-c106-4895-bab3-0579b41f1e751
2591786citalopram 30 MG (as citalopram HBr 37.5 MG) Oral CapsuleSY80af8ae8-c106-4895-bab3-0579b41f1e751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-964-305965109643030 CAPSULE in 1 BOTTLE (59651-964-30) 30 capsule2026-03-13NoNoCurrent