FDA.reportPublic FDA data

Clomiphene citrate

Product NDC
70954-825
11-digit product format
709540825
Labeler code
70954
Product ID
70954-825_b56e04f0-490d-4f10-a0ed-31c288f4f4c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clomiphene citrate
Dosage form
TABLET
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA219781
Marketing category
ANDA
Marketing start
2025-10-17
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 42.

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
A219781-001CLOMIPHENE CITRATECLOMIPHENE CITRATE50MGTABLET / ORALAB2025-10-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219781-001AB

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
2026-08-18 06:07:402026-07A219781-001CLOMIPHENE CITRATE50MGTABLET / ORALAB2025-10-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219781-001CLOMIPHENE CITRATE50MGTABLET / ORALAB2025-10-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219781-001CLOMIPHENE CITRATE50MGTABLET / ORALAB2025-10-1731067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219781-001CLOMIPHENE CITRATE50MGTABLET / ORALAB2025-10-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A219781-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219781-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219781-001AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219781-001AB1a50c72e98297…

Additional Listing Data#

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

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
b56e04f0-490d-4f10-a0ed-31c288f4f4c5Available 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
70954-825-10Clomiphene citrate1 in 1 BLISTER PACKTABLET11
70954-825-20Clomiphene citrate10 in 1 CARTONTABLET101
70954-825-30Clomiphene citrate30 in 1 CARTONTABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-825-20EA - Each70954-82580ba7224-e796-41a4-a499-ed8f3c308e1a12025-11-13
70954-825-30EA - Each70954-82536a42e80-f608-4eed-8a36-abc8dd6e9ccb12025-11-13

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 CITRATEANI Pharmaceuticals, Inc.b56e04f0-490d-4f10-a0ed-31c288f4f4c52026-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219781
application number: ANDA219781
ndc (product): 70954-825

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1093060clomiPHENE citrate 50 MG Oral TabletPSNb56e04f0-490d-4f10-a0ed-31c288f4f4c51
1093060clomiphene citrate 50 MG Oral TabletSCDb56e04f0-490d-4f10-a0ed-31c288f4f4c51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70954-825-10709540825101 in 1 BLISTER PACKHistorical
70954-825-207095408252010 BLISTER PACK in 1 CARTON (70954-825-20) / 1 TABLET in 1 BLISTER PACK (70954-825-10) 10 blister pack2025-10-17NoNoCurrent
70954-825-307095408253030 BLISTER PACK in 1 CARTON (70954-825-30) / 1 TABLET in 1 BLISTER PACK (70954-825-10) 30 blister pack2025-10-17NoNoCurrent