FDA.reportPublic FDA data

Apri

Product NDC
0555-9043
11-digit product format
005559043
Labeler code
0555
Product ID
0555-9043_06176d8d-c9e2-4912-ab6d-ecb3d5e514d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desogestrel and Ethinyl Estradiol
Dosage form
KIT
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA075256
Marketing category
ANDA
Marketing start
1999-10-22
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 43.

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
A075256-001DESOGESTREL AND ETHINYL ESTRADIOLDESOGESTREL; ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-211999-08-12
A075256-002DESOGESTREL AND ETHINYL ESTRADIOLDESOGESTREL; ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28ABRS1999-08-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075256-002AB

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.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075256-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-211999-08-1284e616aacf4f…
2026-09-14 22:38:342026-08A075256-002DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28ABRS1999-08-1284e616aacf4f…
2026-08-18 06:07:402026-07A075256-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-211999-08-12caaa826d4ba7…
2026-08-18 06:07:402026-07A075256-002DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28ABRS1999-08-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075256-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-211999-08-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075256-002DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28ABRS1999-08-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075256-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-211999-08-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075256-002DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28ABRS1999-08-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A075256-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-211999-08-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075256-002DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28ABRS1999-08-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075256-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-211999-08-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075256-002DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28ABRS1999-08-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075256-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-211999-08-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075256-002DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28ABRS1999-08-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075256-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-211999-08-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075256-002DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28ABRS1999-08-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075256-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-211999-08-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075256-002DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28ABRS1999-08-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075256-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-211999-08-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075256-002DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28ABRS1999-08-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075256-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-211999-08-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075256-002DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28ABRS1999-08-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075256-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-211999-08-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A075256-002DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28ABRS1999-08-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075256-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-211999-08-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075256-002DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28ABRS1999-08-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075256-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-211999-08-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075256-002DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28ABRS1999-08-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075256-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-211999-08-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075256-002DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28ABRS1999-08-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075256-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-211999-08-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075256-002DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28ABRS1999-08-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075256-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-211999-08-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075256-002DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28ABRS1999-08-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075256-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-211999-08-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075256-002DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28ABRS1999-08-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075256-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-211999-08-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075256-002DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28ABRS1999-08-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075256-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-211999-08-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075256-002DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28ABRS1999-08-1274a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-09-29 23:25 UTC2022-09A075256-002AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075256-002AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A075256-002AB1a50c72e98297…

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
Apri
Brand name suffix
28 Day
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
240707Internal RxNorm lookup
748797Internal RxNorm lookup
749848Internal RxNorm lookup
753482Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a9e08f9b-9862-4c2c-8302-53dc82d85126Available on FDA.report

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
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
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
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3Product name120140508
d0cc7d42-77a7-b452-c6c3-a162fa11225fProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0555-9043-58Apri28 Day6 in 1 CARTONKIT613
0555-9043-79Apri28 Day1 in 1 POUCHKIT113
0555-9043-79Apri28 Day1 in 1 BLISTER PACKKIT113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-9043-58EA - Each0555-90437f775376-e895-4179-b449-32533921743d12012-07-24
0555-9043-79EA - Each0555-90436711630b-c287-4eeb-92c6-5b24522569e612017-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DESOGESTRELACTIVE INGREDIENT81K9V7M3A3APRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UAPRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
DESOGESTRELACTIVE MOIETY81K9V7M3A3APRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UAPRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1APRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933APRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKAPRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAPRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAPRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAPRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82APRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6APRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LAPRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAPRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30APRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQAPRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BAPRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HAPRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
POVIDONE K30INACTIVE INGREDIENTU725QWY32XAPRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4APRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAPRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APAPRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAPRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]6
DESOGESTRELACTIVE INGREDIENT81K9V7M3A3APRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UAPRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
DESOGESTRELACTIVE MOIETY81K9V7M3A3APRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UAPRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1APRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933APRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKAPRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAPRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAPRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAPRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAPRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAPRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30APRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AAPRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HAPRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EAPRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4APRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAPRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APAPRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAPRI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-9043APRI 28 DAY (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.]13Current NDC, Legacy NDC, 3 package rows20211228_a9e08f9b-9862-4c2c-8302-53dc82d85126.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Apri 28 DayDESOGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutions3448d121-d00a-4752-8782-416b7a376f3f2024-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075256
application number: ANDA075256
Reclipsen 28 DayDESOGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.a1e00bc6-7487-4057-9dcc-d0e2327d1d122022-01-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075256
application number: ANDA075256
Apri 28 DayDESOGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.a9e08f9b-9862-4c2c-8302-53dc82d851262021-12-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075256
application number: ANDA075256
ndc (product): 0555-9043

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
753482{21 (desogestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Apri 28 Day]BPCK3448d121-d00a-4752-8782-416b7a376f3f23
749848{21 (desogestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK3448d121-d00a-4752-8782-416b7a376f3f23
753482Apri 28 Day PackPSN3448d121-d00a-4752-8782-416b7a376f3f23
749848Desogest-Eth estra 0.15-0.03 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN3448d121-d00a-4752-8782-416b7a376f3f23
240707desogestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral TabletPSN3448d121-d00a-4752-8782-416b7a376f3f23
748797inert 1 MG Oral TabletPSN3448d121-d00a-4752-8782-416b7a376f3f23
240707desogestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral TabletSCD3448d121-d00a-4752-8782-416b7a376f3f23
748797inert ingredients 1 MG Oral TabletSCD3448d121-d00a-4752-8782-416b7a376f3f23
753482Apri 28 Day PackSY3448d121-d00a-4752-8782-416b7a376f3f23
753482{21 (desogestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Apri 28 Day]BPCKa9e08f9b-9862-4c2c-8302-53dc82d8512613
749848{21 (desogestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCKa9e08f9b-9862-4c2c-8302-53dc82d8512613
753482Apri 28 Day PackPSNa9e08f9b-9862-4c2c-8302-53dc82d8512613
749848Desogest-Eth estra 0.15-0.03 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSNa9e08f9b-9862-4c2c-8302-53dc82d8512613
240707desogestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral TabletPSNa9e08f9b-9862-4c2c-8302-53dc82d8512613
748797inert 1 MG Oral TabletPSNa9e08f9b-9862-4c2c-8302-53dc82d8512613
240707desogestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral TabletSCDa9e08f9b-9862-4c2c-8302-53dc82d8512613
748797inert ingredients 1 MG Oral TabletSCDa9e08f9b-9862-4c2c-8302-53dc82d8512613
753482Apri 28 Day PackSYa9e08f9b-9862-4c2c-8302-53dc82d8512613
753482{21 (desogestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Apri 28 Day]BPCKf3d91179-27e3-4bac-be47-8f224c836f5f1
749848{21 (desogestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCKf3d91179-27e3-4bac-be47-8f224c836f5f1
753482Apri 28 Day PackPSNf3d91179-27e3-4bac-be47-8f224c836f5f1
749848Desogest-Eth estra 0.15-0.03 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSNf3d91179-27e3-4bac-be47-8f224c836f5f1
240707desogestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral TabletPSNf3d91179-27e3-4bac-be47-8f224c836f5f1
748797inert 1 MG Oral TabletPSNf3d91179-27e3-4bac-be47-8f224c836f5f1
240707desogestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral TabletSCDf3d91179-27e3-4bac-be47-8f224c836f5f1
748797inert ingredients 1 MG Oral TabletSCDf3d91179-27e3-4bac-be47-8f224c836f5f1
753482Apri 28 Day PackSYf3d91179-27e3-4bac-be47-8f224c836f5f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0555-9043-58005559043586 POUCH in 1 CARTON (0555-9043-58) / 1 BLISTER PACK in 1 POUCH (0555-9043-79) / 1 KIT in 1 BLISTER PACK6 pouch1999-10-220000-00-00NoNoCurrent
0555-9043-79005559043791 in 1 POUCHHistorical