FDA.reportPublic FDA data

Kelnor 1/35

Product NDC
0555-9064
11-digit product format
005559064
Labeler code
0555
Product ID
0555-9064_a579e715-cf4d-4d28-9bb7-3b4e2d4dc4d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ethynodiol Diacetate and Ethinyl Estradiol
Dosage form
KIT
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA076785
Marketing category
ANDA
Marketing start
2005-06-20
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Kelnor 1/35
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui310228, 748797, 748804, 753483

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
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3Product name120140508
d0cc7d42-77a7-b452-c6c3-a162fa11225fProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0555-9064-58Kelnor 1/356 in 1 CARTONKIT614
0555-9064-79Kelnor 1/351 in 1 BLISTER PACKKIT114
0555-9064-79Kelnor 1/351 in 1 POUCHKIT114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-9064-58EA - Each0555-9064d4998f1c-bc55-4ac0-a3f2-db451e00912c12013-02-13
0555-9064-67EA - Each0555-90643b1d2b3a-6905-4a04-a521-78c38a7ce2c812013-02-13
0555-9064-79EA - Each0555-90642c483d70-de9a-4c65-851e-91f270d04dc612017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
ETHYNODIOL DIACETATEACTIVE INGREDIENT62H10A1236KELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
ETHYNODIOLACTIVE MOIETY9E01C36A9SKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933KELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
HYPROMELLOSE 2208 (3 MPA.S)INACTIVE INGREDIENT9H4L916OBUKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30KELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
ETHYNODIOL DIACETATEACTIVE INGREDIENT62H10A1236KELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
ETHYNODIOLACTIVE MOIETY9E01C36A9SKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933KELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30KELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
POVIDONE K12INACTIVE INGREDIENT333AG72FWJKELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-9064KELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.]14Current NDC, Legacy NDC, 3 package rows20221022_96a73786-22b1-457e-be73-80b699996d40.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
753483{21 (ethinyl estradiol 0.035 MG / ethynodiol diacetate 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Kelnor 1/35 28 Day]BPCK96a73786-22b1-457e-be73-80b699996d4014
748804{21 (ethinyl estradiol 0.035 MG / ethynodiol diacetate 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK96a73786-22b1-457e-be73-80b699996d4014
748804Eth estra-Ethyn 0.035-1 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN96a73786-22b1-457e-be73-80b699996d4014
310228ethynodiol diacetate 1 MG / ethinyl estradiol 35 MCG Oral TabletPSN96a73786-22b1-457e-be73-80b699996d4014
748797inert 1 MG Oral TabletPSN96a73786-22b1-457e-be73-80b699996d4014
753483Kelnor 1/35 28 Day PackPSN96a73786-22b1-457e-be73-80b699996d4014
310228ethinyl estradiol 0.035 MG / ethynodiol diacetate 1 MG Oral TabletSCD96a73786-22b1-457e-be73-80b699996d4014
748797inert ingredients 1 MG Oral TabletSCD96a73786-22b1-457e-be73-80b699996d4014
310228ethinyl estradiol 35 MCG / ethynodiol 1 MG Oral TabletSY96a73786-22b1-457e-be73-80b699996d4014
753483Kelnor 1/35 28 Day PackSY96a73786-22b1-457e-be73-80b699996d4014
753483{21 (ethinyl estradiol 0.035 MG / ethynodiol diacetate 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Kelnor 1/35 28 Day]BPCKcfa297a6-1cc7-4751-b8ea-0e57965f1ca912
748804{21 (ethinyl estradiol 0.035 MG / ethynodiol diacetate 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCKcfa297a6-1cc7-4751-b8ea-0e57965f1ca912
748804Eth estra-Ethyn 0.035-1 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSNcfa297a6-1cc7-4751-b8ea-0e57965f1ca912
310228ethynodiol diacetate 1 MG / ethinyl estradiol 35 MCG Oral TabletPSNcfa297a6-1cc7-4751-b8ea-0e57965f1ca912
748797inert 1 MG Oral TabletPSNcfa297a6-1cc7-4751-b8ea-0e57965f1ca912
753483Kelnor 1/35 28 Day PackPSNcfa297a6-1cc7-4751-b8ea-0e57965f1ca912
310228ethinyl estradiol 0.035 MG / ethynodiol diacetate 1 MG Oral TabletSCDcfa297a6-1cc7-4751-b8ea-0e57965f1ca912
748797inert ingredients 1 MG Oral TabletSCDcfa297a6-1cc7-4751-b8ea-0e57965f1ca912
310228ethinyl estradiol 35 MCG / ethynodiol 1 MG Oral TabletSYcfa297a6-1cc7-4751-b8ea-0e57965f1ca912
753483Kelnor 1/35 28 Day PackSYcfa297a6-1cc7-4751-b8ea-0e57965f1ca912
753483{21 (ethinyl estradiol 0.035 MG / ethynodiol diacetate 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Kelnor 1/35 28 Day]BPCK994cefc2-0724-4b56-a816-ccdabef5492e2
748804{21 (ethinyl estradiol 0.035 MG / ethynodiol diacetate 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK994cefc2-0724-4b56-a816-ccdabef5492e2
748804Eth estra-Ethyn 0.035-1 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN994cefc2-0724-4b56-a816-ccdabef5492e2
310228ethynodiol diacetate 1 MG / ethinyl estradiol 35 MCG Oral TabletPSN994cefc2-0724-4b56-a816-ccdabef5492e2
748797inert 1 MG Oral TabletPSN994cefc2-0724-4b56-a816-ccdabef5492e2
753483Kelnor 1/35 28 Day PackPSN994cefc2-0724-4b56-a816-ccdabef5492e2
310228ethinyl estradiol 0.035 MG / ethynodiol diacetate 1 MG Oral TabletSCD994cefc2-0724-4b56-a816-ccdabef5492e2
748797inert ingredients 1 MG Oral TabletSCD994cefc2-0724-4b56-a816-ccdabef5492e2
310228ethinyl estradiol 35 MCG / ethynodiol 1 MG Oral TabletSY994cefc2-0724-4b56-a816-ccdabef5492e2
753483Kelnor 1/35 28 Day PackSY994cefc2-0724-4b56-a816-ccdabef5492e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0555-9064-58005559064586 POUCH in 1 CARTON (0555-9064-58) / 1 BLISTER PACK in 1 POUCH (0555-9064-79) / 1 KIT in 1 BLISTER PACK6 pouch2005-06-200000-00-00NoNoCurrent
0555-9064-79005559064791 in 1 BLISTER PACKHistorical