FDA.reportPublic FDA data

Clomiphene Citrate

Product NDC
16729-723
Requested package NDC
16729-723-51
11-digit product format
167290723
Labeler code
16729
Product ID
16729-723_44e70204-6bed-9d96-e063-6294a90aa3cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clomiphene Citrate
Dosage form
TABLET
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA219406
Marketing category
ANDA
Marketing start
2025-11-21
Substance
CLOMIPHENE CITRATE
Active strength
50 mg/1
Pharmacologic classes
Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
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
A219406-001CLOMIPHENE CITRATECLOMIPHENE CITRATE50MGTABLET / ORALAB2025-10-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219406-001AB

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
2026-02-19 14:30 UTC2026-02A219406-001CLOMIPHENE CITRATE50MGTABLET / ORALAB2025-10-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219406-001CLOMIPHENE CITRATE50MGTABLET / ORALAB2025-10-0331067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219406-001CLOMIPHENE CITRATE50MGTABLET / ORALAB2025-10-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A219406-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219406-001AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219406-001AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Clomiphene Citrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOMIPHENE CITRATE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1B8447E7YIInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1093060Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
79f64995-7425-44c6-9f44-f7d20daeff65Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c924cb97-cd84-d0fe-8911-51a8a0fb2420Product name220250625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-723-44Clomiphene Citrate10 in 1 BLISTER PACKTABLET103
16729-723-44Clomiphene Citrate1 in 1 CARTONTABLET13
16729-723-51Clomiphene Citrate1 in 1 CARTONTABLET13
16729-723-51Clomiphene Citrate30 in 1 BLISTER PACKTABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-723-44EA - Each16729-7238fd7c25b-75a0-4a25-a263-5f6f448b280712025-12-16
16729-723-51EA - Each16729-723358dec2f-5b10-4083-9f49-1fa6f3c41ae412025-12-16

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
Clomiphene CitrateCLOMIPHENE CITRATEAccord Healthcare Inc.79f64995-7425-44c6-9f44-f7d20daeff652025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219406
application number: ANDA219406
ndc (package): 16729-723-51
ndc (product): 16729-723
ndc11 (package): 16729072351

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1093060clomiPHENE citrate 50 MG Oral TabletPSN79f64995-7425-44c6-9f44-f7d20daeff653
1093060clomiphene citrate 50 MG Oral TabletSCD79f64995-7425-44c6-9f44-f7d20daeff653

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16729-723-51167290723511 BLISTER PACK in 1 CARTON (16729-723-51) / 30 TABLET in 1 BLISTER PACK1 blister pack2025-11-21NoNoCurrent