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

Additional Listing Data#

Finished product
Yes
Brand name base
Apri
Brand name suffix
28 Day
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui240707, 748797, 749848, 753482

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

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