FDA.reportPublic FDA data

AVERI

Product NDC
75854-604
11-digit product format
758540604
Labeler code
75854
Product ID
75854-604_3bc4c615-77f6-47b5-af57-ebefeed6cca9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
desogestrel and ethinyl estradiol
Dosage form
KIT
Labeler
Avion Pharmaceuticals, LLC
Application
ANDA218933
Marketing category
ANDA
Marketing start
2025-06-05
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct75854-604DDiscontinued by firm2026-09-09
excluded packagepackage75854-60475854-604-01DDiscontinued by firm2026-09-09
excluded packagepackage75854-60475854-604-03DDiscontinued by firm2026-09-09

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218933-001AVERIDESOGESTREL; ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-212025-05-02
A218933-002AVERIDESOGESTREL; ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28AB2025-05-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218933-002AB

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 06:07:402026-07A218933-001AVERI0.15MG;0.03MGTABLET / ORAL-212025-05-02caaa826d4ba7…
2026-08-18 06:07:402026-07A218933-002AVERI0.15MG;0.03MGTABLET / ORAL-28AB2025-05-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218933-001AVERI0.15MG;0.03MGTABLET / ORAL-212025-05-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218933-002AVERI0.15MG;0.03MGTABLET / ORAL-28AB2025-05-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218933-001AVERI0.15MG;0.03MGTABLET / ORAL-212025-05-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218933-002AVERI0.15MG;0.03MGTABLET / ORAL-28AB2025-05-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A218933-001AVERI0.15MG;0.03MGTABLET / ORAL-212025-05-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218933-002AVERI0.15MG;0.03MGTABLET / ORAL-28AB2025-05-026a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218933-001AVERI0.15MG;0.03MGTABLET / ORAL-212025-05-02a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218933-002AVERI0.15MG;0.03MGTABLET / ORAL-28AB2025-05-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A218933-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218933-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218933-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218933-002AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218933-002AB1a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1ecea64-06d1-4fdc-a2a1-b801e0cd0d11Product name420250623
d39a542a-f5b0-4c2d-a820-0f5d39e6621fProduct name120250307
8511fc19-172b-4e1f-90ec-2f09c85b16deProduct name220250116
d9a998ac-31a9-4391-9054-c30e50912603Product name220240829
782f1593-b73e-4d35-8017-647969d714d8Product name420240805
1a545a57-aed5-4b6e-b1f9-a93c26d50effProduct name120230829
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50Product name320230718
a057e1a7-94b1-4663-8d17-a3bbf3a12689Product name520230627
0d9f32e2-f85b-4d63-9f04-b06059c34749Product name320230323
fa479cfe-0bd0-7366-d57a-92f3682e87c5Product name320210518
20e1a411-dba8-4afa-b9f9-1205d5b0bde9Product name320210513
cec4644c-0fed-4608-a5ea-d3a1b1b6d697Product name220200728
00a01e22-7ea3-6f8f-0cc1-380aac10f424Product name620200716
5956a0e2-c373-452c-bdcf-c93d354432efProduct name120200714
ca306105-d51c-4821-9ec1-8eec753d073dProduct name120200619
f1d1b304-0b6c-25e9-a872-86d3d4bd2ab9Product name820200612
0381745d-0d4c-bcc1-87eb-abb98c1e6cb6Product name820191120
6dd982ab-2966-22ee-3b75-d225abb791aaProduct name520190612
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4dProduct name720190612
f92411e4-13dd-7baf-106e-9b3fcf758c39Product name420190502
60ff9adc-7870-42ca-8836-514bd9732fa8Product name420181220
ddff2484-d547-4e6a-bacd-95eef7e31c64Product name220180807
c6636356-4ccb-40e9-a952-59eb1f2fc859Product name420180806
79d5025d-8129-440a-b861-6df2d2661609Product name320180607
e042bc86-5d40-8945-82f8-de9dd95420ddProduct name620180606
d871c48c-6b0b-4203-b55d-72ead21ea7adProduct name520180419
90854981-3820-4bc4-a1d3-666ec508941cProduct name220180214
390e6d23-3a11-4327-9294-c958a378baaeProduct name420180124
12434b90-2738-45d5-9e1b-55001e853273Product name220171122
b651f154-0364-4007-9dc6-9d33036db1d7Product name420170808
3395ac9b-f30b-4991-80ba-fd5196be0214Product name320170802
2d386545-84d1-e1e9-1402-7fc8962353e8Product name220170717
a5e2d962-d98c-4fbf-8183-ffd42dd01e19Product name620170711
30783b73-16b0-4cc1-b03a-e5d801c0d7a8Product name420170608
00606b81-6e33-4c38-9ca9-bd14bd74d84cProduct name420170501
f4ce24e8-8632-4fad-9984-b693f985f80fProduct name320170501
b17c5419-b38b-579f-10bc-8a4ce69fc044Product name520170316
120cc5ad-761c-444c-9e82-dec22f96dfe1Product name720161219
01996782-abcb-4e6d-bcaf-4a23e6a95c0cProduct name120160714
2aecf0b6-88a0-49e5-92e1-983c700c116cProduct name120151222
61972742-5d4d-491d-a881-b6bc3a011577Product name120151113
5e13e814-349e-3480-99f3-ee22a591426fProduct name220150518
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3Product name120140508
d0cc7d42-77a7-b452-c6c3-a162fa11225fProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75854-604-01AVERI1 in 1 CARTONKIT12
75854-604-01AVERI1 in 1 BLISTER PACKKIT12
75854-604-03AVERI3 in 1 CARTONKIT32
75854-604-03AVERI1 in 1 BLISTER PACKKIT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75854-604-01EA - Each75854-6046bd7832d-fa83-473b-9c75-7c2f3bba47d312025-07-08
75854-604-03EA - Each75854-604e701e647-facd-434e-b88d-540e6db9918b12025-07-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2716397{21 (desogestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet) / 7 (ferrous bisglycinate 36.5 MG Oral Tablet) } Pack [Averi 28 Day]BPCK91359e20-0de1-4995-b525-58b7544e34dc2
2716396{21 (desogestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet) / 7 (ferrous bisglycinate 36.5 MG Oral Tablet) } PackGPCK91359e20-0de1-4995-b525-58b7544e34dc2
2716397Averi 28 Day PackPSN91359e20-0de1-4995-b525-58b7544e34dc2
2716396desogest-eth estra 0.15-0.03 MG (21) Oral Tablet / ferrous bisglycinate 36.5 MG (7) Oral Tablet 28 Day PackPSN91359e20-0de1-4995-b525-58b7544e34dc2
240707desogestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral TabletPSN91359e20-0de1-4995-b525-58b7544e34dc2
2672922ferrous bisglycinate 36.5 MG Oral TabletPSN91359e20-0de1-4995-b525-58b7544e34dc2
240707desogestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral TabletSCD91359e20-0de1-4995-b525-58b7544e34dc2
2672922ferrous bisglycinate 36.5 MG Oral TabletSCD91359e20-0de1-4995-b525-58b7544e34dc2
2716396{21 (desogestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet) / 7 (ferrous bisglycinate 36.5 MG Oral Tablet) } 28 Day PackSY91359e20-0de1-4995-b525-58b7544e34dc2
2716397Averi 28 Day PackSY91359e20-0de1-4995-b525-58b7544e34dc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75854-604-01758540604011 BLISTER PACK in 1 CARTON (75854-604-01) / 1 KIT in 1 BLISTER PACK1 blister pack2025-06-05NoNoHistorical
75854-604-03758540604033 BLISTER PACK in 1 CARTON (75854-604-03) / 1 KIT in 1 BLISTER PACK3 blister pack2025-06-05NoNoHistorical