FDA.reportPublic FDA data

ALYACEN 1/35

Product NDC
68462-394
11-digit product format
684620394
Labeler code
68462
Product ID
68462-394_9d4967e6-42df-4468-99a6-9b57499497d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
norethindrone and ethinyl estradiol
Dosage form
KIT
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA091634
Marketing category
ANDA
Marketing start
2012-01-19
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ALYACEN 1/35
Listing expiration
2027-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui310463, 312033, 392662, 748797, 749852, 749858, 1242786, 1242787

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
859c4b0b-8cba-4f41-9afe-cc181a01fb62Product name220240215
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
833edb59-a012-45c2-aff5-2ed74b66fa59Product name120201207
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
f4d31098-441e-52d3-27f1-49c829f8a3a1Product name520190703
6dd982ab-2966-22ee-3b75-d225abb791aaProduct name520190612
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4dProduct name720190612
f92411e4-13dd-7baf-106e-9b3fcf758c39Product name420190502
c21bcd2e-ecbd-48e6-ab68-12cc12256c0fProduct name220190213
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
f6ac5560-6d3b-d281-41d2-adc50d283c20Product name320170228
120cc5ad-761c-444c-9e82-dec22f96dfe1Product name720161219
01996782-abcb-4e6d-bcaf-4a23e6a95c0cProduct name120160714
2aecf0b6-88a0-49e5-92e1-983c700c116cProduct name120151222
61972742-5d4d-491d-a881-b6bc3a011577Product name120151113
23ede539-308f-46e5-817b-41ef23af8d40Product name120150930
425e3610-bbe8-4d70-9c46-8cf09afc4e4dProduct name120150930
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
68462-394-29ALYACEN 1/353 in 1 CARTONKIT310
68462-394-84ALYACEN 1/351 in 1 BLISTER PACKKIT110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-394-29EA - Each68462-394e3a65ebb-1bc5-457a-a6fc-f63c5848597512012-07-24
68462-394-84EA - Each68462-394eed416a9-37f7-49d0-8490-46c2821f5cfa12015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UALYACEN 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]6
NORETHINDRONEACTIVE INGREDIENTT18F433X4SALYACEN 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]6
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UALYACEN 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]6
NORETHINDRONEACTIVE MOIETYT18F433X4SALYACEN 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]6
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKALYACEN 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALYACEN 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GALYACEN 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALYACEN 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALYACEN 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALYACEN 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALYACEN 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALYACEN 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALYACEN 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]6
TALCINACTIVE INGREDIENT7SEV7J4R1UALYACEN 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-394ALYACEN 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA]9Current NDC, Legacy NDC, 2 package rows20240104_5c02b4d3-1e2f-439a-ae45-02304ee190d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1242786{21 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Alyacen 1/35]BPCKa45ee86e-69ca-49a5-8990-5dde52d4a52214
749858{21 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCKa45ee86e-69ca-49a5-8990-5dde52d4a52214
1242786ALYACEN 1/35 28 Day PackPSNa45ee86e-69ca-49a5-8990-5dde52d4a52214
749858Eth estra-Noreth 0.035-1 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSNa45ee86e-69ca-49a5-8990-5dde52d4a52214
748797inert 1 MG Oral TabletPSNa45ee86e-69ca-49a5-8990-5dde52d4a52214
312033norethindrone acetate 1 MG / ethinyl estradiol 35 MCG Oral TabletPSNa45ee86e-69ca-49a5-8990-5dde52d4a52214
312033ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral TabletSCDa45ee86e-69ca-49a5-8990-5dde52d4a52214
748797inert ingredients 1 MG Oral TabletSCDa45ee86e-69ca-49a5-8990-5dde52d4a52214
1242786Alyacen 1/35 28-Day KitSYa45ee86e-69ca-49a5-8990-5dde52d4a52214
312033ethinyl estradiol 35 MCG / norethindrone 1 MG Oral TabletSYa45ee86e-69ca-49a5-8990-5dde52d4a52214
1242786{21 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Alyacen 1/35]BPCK5c02b4d3-1e2f-439a-ae45-02304ee190d110
1242787{7 (ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norethindrone 0.75 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Alyacen 7/7/7]BPCK5c02b4d3-1e2f-439a-ae45-02304ee190d110
749858{21 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK5c02b4d3-1e2f-439a-ae45-02304ee190d110
749852{7 (ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norethindrone 0.75 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK5c02b4d3-1e2f-439a-ae45-02304ee190d110
1242786ALYACEN 1/35 28 Day PackPSN5c02b4d3-1e2f-439a-ae45-02304ee190d110
1242787ALYACEN 7/7/7 28 Day PackPSN5c02b4d3-1e2f-439a-ae45-02304ee190d110
749852Eth estra-Noreth 0.035-0.5 MG (7) Oral Tablet / Eth estra-Noreth 0.035-0.75 MG (7) Oral Tablet / Eth estra-Noreth 0.035-1 MG (7) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN5c02b4d3-1e2f-439a-ae45-02304ee190d110
749858Eth estra-Noreth 0.035-1 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN5c02b4d3-1e2f-439a-ae45-02304ee190d110
748797inert 1 MG Oral TabletPSN5c02b4d3-1e2f-439a-ae45-02304ee190d110
310463norethindrone 0.5 MG / ethinyl estradiol 0.035 MG Oral TabletPSN5c02b4d3-1e2f-439a-ae45-02304ee190d110
392662norethindrone 0.75 MG / ethinyl estradiol 0.035 MG Oral TabletPSN5c02b4d3-1e2f-439a-ae45-02304ee190d110
312033norethindrone acetate 1 MG / ethinyl estradiol 35 MCG Oral TabletPSN5c02b4d3-1e2f-439a-ae45-02304ee190d110
310463ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral TabletSCD5c02b4d3-1e2f-439a-ae45-02304ee190d110
392662ethinyl estradiol 0.035 MG / norethindrone 0.75 MG Oral TabletSCD5c02b4d3-1e2f-439a-ae45-02304ee190d110
312033ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral TabletSCD5c02b4d3-1e2f-439a-ae45-02304ee190d110
748797inert ingredients 1 MG Oral TabletSCD5c02b4d3-1e2f-439a-ae45-02304ee190d110
1242786Alyacen 1/35 28-Day KitSY5c02b4d3-1e2f-439a-ae45-02304ee190d110
1242787Alyacen 7/7/7 28-Day KitSY5c02b4d3-1e2f-439a-ae45-02304ee190d110
1242787Alyacen 7/7/7 KitSY5c02b4d3-1e2f-439a-ae45-02304ee190d110
310463ethinyl estradiol 35 MCG / norethindrone 0.5 MG Oral TabletSY5c02b4d3-1e2f-439a-ae45-02304ee190d110
392662ethinyl estradiol 35 MCG / norethindrone 0.75 MG Oral TabletSY5c02b4d3-1e2f-439a-ae45-02304ee190d110
312033ethinyl estradiol 35 MCG / norethindrone 1 MG Oral TabletSY5c02b4d3-1e2f-439a-ae45-02304ee190d110
1242786{21 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Alyacen 1/35]BPCK5c4c8517-b81a-4716-be70-1b2b7e7dd1464
749858{21 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK5c4c8517-b81a-4716-be70-1b2b7e7dd1464
1242786ALYACEN 1/35 28 Day PackPSN5c4c8517-b81a-4716-be70-1b2b7e7dd1464
749858Eth estra-Noreth 0.035-1 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN5c4c8517-b81a-4716-be70-1b2b7e7dd1464
748797inert 1 MG Oral TabletPSN5c4c8517-b81a-4716-be70-1b2b7e7dd1464
312033norethindrone acetate 1 MG / ethinyl estradiol 35 MCG Oral TabletPSN5c4c8517-b81a-4716-be70-1b2b7e7dd1464
312033ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral TabletSCD5c4c8517-b81a-4716-be70-1b2b7e7dd1464
748797inert ingredients 1 MG Oral TabletSCD5c4c8517-b81a-4716-be70-1b2b7e7dd1464
1242786Alyacen 1/35 28-Day KitSY5c4c8517-b81a-4716-be70-1b2b7e7dd1464
312033ethinyl estradiol 35 MCG / norethindrone 1 MG Oral TabletSY5c4c8517-b81a-4716-be70-1b2b7e7dd1464
1242786{21 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Alyacen 1/35]BPCKfa32e05b-c86d-4743-aee5-be3fc515152b2
749858{21 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCKfa32e05b-c86d-4743-aee5-be3fc515152b2
1242786ALYACEN 1/35 28 Day PackPSNfa32e05b-c86d-4743-aee5-be3fc515152b2
749858Eth estra-Noreth 0.035-1 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSNfa32e05b-c86d-4743-aee5-be3fc515152b2
748797inert 1 MG Oral TabletPSNfa32e05b-c86d-4743-aee5-be3fc515152b2
312033norethindrone acetate 1 MG / ethinyl estradiol 35 MCG Oral TabletPSNfa32e05b-c86d-4743-aee5-be3fc515152b2
312033ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral TabletSCDfa32e05b-c86d-4743-aee5-be3fc515152b2
748797inert ingredients 1 MG Oral TabletSCDfa32e05b-c86d-4743-aee5-be3fc515152b2
1242786Alyacen 1/35 28-Day KitSYfa32e05b-c86d-4743-aee5-be3fc515152b2
312033ethinyl estradiol 35 MCG / norethindrone 1 MG Oral TabletSYfa32e05b-c86d-4743-aee5-be3fc515152b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-394-29684620394293 BLISTER PACK in 1 CARTON (68462-394-29) / 1 KIT in 1 BLISTER PACK (68462-394-84) 3 blister pack2012-01-190000-00-00NoNoCurrent
68462-394-84684620394841 in 1 BLISTER PACKHistorical