Citalopram

Product NDC
67046-101
Requested package NDC
67046-101-21
11-digit product format
670460101
Labeler code
67046
Product ID
67046-101_bc1abb84-40ea-1aee-e053-2995a90af27c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
citalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA077042
Marketing category
ANDA
Marketing start
2017-09-19
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67046-10167046-101-21IInactivated by FDA2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
A077042-001CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-11-05
A077042-002CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-11-05
A077042-003CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-11-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077042-001AB
A077042-002AB
A077042-003AB

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 UTC2026-02A077042-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077042-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077042-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-11-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077042-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077042-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077042-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-11-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A077042-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077042-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077042-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-11-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077042-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077042-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077042-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-11-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077042-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077042-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077042-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-11-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077042-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077042-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077042-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-11-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077042-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077042-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077042-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-11-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077042-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077042-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077042-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-11-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077042-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-11-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077042-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-11-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077042-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-11-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077042-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-11-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A077042-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-11-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A077042-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-11-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077042-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-11-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077042-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-11-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077042-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-11-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077042-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-11-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077042-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-11-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077042-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-11-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077042-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-11-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077042-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-11-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077042-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-11-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077042-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-11-058072bd15b7f6…

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 UTC2026-02A077042-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077042-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077042-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077042-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077042-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077042-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077042-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077042-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077042-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077042-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077042-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077042-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077042-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077042-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077042-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077042-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077042-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077042-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077042-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077042-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077042-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077042-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077042-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077042-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077042-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077042-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077042-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077042-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077042-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077042-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077042-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077042-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077042-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077042-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077042-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077042-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077042-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077042-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077042-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077042-001AB18072bd15b7f6…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-101-07Citalopram7 in 1 BLISTER PACKTABLET, FILM COATED73
67046-101-14Citalopram14 in 1 BLISTER PACKTABLET, FILM COATED143
67046-101-15Citalopram15 in 1 BLISTER PACKTABLET, FILM COATED153
67046-101-21Citalopram21 in 1 BLISTER PACKTABLET, FILM COATED213
67046-101-28Citalopram28 in 1 BLISTER PACKTABLET, FILM COATED283
67046-101-30Citalopram30 in 1 BLISTER PACKTABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-101CITALOPRAM TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]3Legacy NDC, 6 package rows20210225_598cc779-06be-b27a-e053-2a91aa0a0909.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 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CitalopramCITALOPRAMREMEDYREPACK INC.f79f878e-99fb-4757-8abb-931af1fa9e2b2026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077042
application number: ANDA077042
CitalopramCITALOPRAMREMEDYREPACK INC.aa9c1440-354f-43a6-9e70-fd7bafcb03c52026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077042
application number: ANDA077042
CitalopramCITALOPRAMBryant Ranch Prepack2a8acad8-0ba0-4631-9f6d-f587e7a8558c2024-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077042
application number: ANDA077042
CitalopramCITALOPRAMMylan Pharmaceuticals Inc.825c0c49-5fbf-6d8b-cb8c-94ebf0eda0432024-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077042
application number: ANDA077042
CitalopramCITALOPRAMNuCare Pharmaceuticals,Inc.0dfb11d9-f48d-56ee-e063-6294a90ad2562024-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077042
application number: ANDA077042

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSN598cc779-06be-b27a-e053-2a91aa0a09093
200371citalopram 20 MG Oral TabletPSN598cc779-06be-b27a-e053-2a91aa0a09093
309314citalopram 40 MG Oral TabletPSN598cc779-06be-b27a-e053-2a91aa0a09093
283672citalopram 10 MG Oral TabletSCD598cc779-06be-b27a-e053-2a91aa0a09093
200371citalopram 20 MG Oral TabletSCD598cc779-06be-b27a-e053-2a91aa0a09093
309314citalopram 40 MG Oral TabletSCD598cc779-06be-b27a-e053-2a91aa0a09093
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY598cc779-06be-b27a-e053-2a91aa0a09093
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY598cc779-06be-b27a-e053-2a91aa0a09093
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY598cc779-06be-b27a-e053-2a91aa0a09093

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67046-101-216704601012121 TABLET, FILM COATED in 1 BLISTER PACK (67046-101-21) 2017-09-190000-00-00NoNoCurrent