Desogestrel and Ethinyl Estradiol

Product NDC
31722-540
11-digit product format
317220540
Labeler code
31722
Product ID
31722-540_54f9ba06-3693-86dd-e063-6294a90a548c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desogestrel and Ethinyl Estradiol
Dosage form
KIT
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA219761
Marketing category
ANDA
Marketing start
2026-03-18
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 44.

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
A219761-001DESOGESTREL AND ETHINYL ESTRADIOLDESOGESTREL; ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28AB2026-03-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219761-001AB

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
2026-10-15 13:18:302026-09A219761-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28AB2026-03-18c2088c7a36db…
2026-09-14 22:38:342026-08A219761-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28AB2026-03-1884e616aacf4f…
2026-08-18 06:07:402026-07A219761-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28AB2026-03-18caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219761-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28AB2026-03-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A219761-001AB1c2088c7a36db…
2026-09-14 22:38:342026-08A219761-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A219761-001AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219761-001AB1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Desogestrel and Ethinyl Estradiol
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
240707Internal RxNorm lookup
748797Internal RxNorm lookup
749848Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
78454ebf-f1a3-4ca0-b32e-88c51bc57773Available on FDA.report

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
Desogestrel and Ethinyl EstradiolDESOGESTREL AND ETHINYL ESTRADIOLCamber Pharmaceuticals, Inc.78454ebf-f1a3-4ca0-b32e-88c51bc577732026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219761
application number: ANDA219761
ndc (product): 31722-540

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-540-33317220540336 POUCH in 1 CARTON (31722-540-33) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK6 pouch2026-03-18NoNoCurrent
31722-540-34317220540343 POUCH in 1 CARTON (31722-540-34) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK3 pouch2026-03-18NoNoCurrent