FDA.reportPublic FDA data

ALYACEN 7/7/7

Product NDC
68462-556
11-digit product format
684620556
Labeler code
68462
Product ID
68462-556_9d4967e6-42df-4468-99a6-9b57499497d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
norethindrone and ethinyl estradiol
Dosage form
KIT
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA091636
Marketing category
ANDA
Marketing start
2012-01-19
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091636-001ALYACEN 7/7/7ETHINYL ESTRADIOL; NORETHINDRONE0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MGTABLET / ORAL-28AB2012-01-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091636-001AB

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
2026-08-01 22:54:322026-06A091636-001ALYACEN 7/7/70.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MGTABLET / ORAL-28AB2012-01-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A091636-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALYACEN 1/35NORETHINDRONE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA5c02b4d3-1e2f-439a-ae45-02304ee190d12026-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091636
application number: ANDA091636
ndc (product): 68462-556

Additional Listing Data#

Finished product
Yes
Brand name base
ALYACEN 7/7/7
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310463Internal RxNorm lookup
312033Internal RxNorm lookup
392662Internal RxNorm lookup
748797Internal RxNorm lookup
749852Internal RxNorm lookup
749858Internal RxNorm lookup
1242786Internal RxNorm lookup
1242787Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5c02b4d3-1e2f-439a-ae45-02304ee190d1Available 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
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
68462-556-29ALYACEN 7/7/73 in 1 CARTONKIT310
68462-556-84ALYACEN 7/7/71 in 1 BLISTER PACKKIT110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-556-29EA - Each68462-556fd35197f-2766-465c-9845-ae0ff8866da212012-07-24
68462-556-84EA - Each68462-5569c719cee-f97d-4d2b-8871-a05ef6e8d93e12015-07-20

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
68462-556ALYACEN 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]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
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]BPCK46fd5feb-66c5-4f3b-aa8d-3f03d6964e945
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) } PackGPCK46fd5feb-66c5-4f3b-aa8d-3f03d6964e945
1242787ALYACEN 7/7/7 28 Day PackPSN46fd5feb-66c5-4f3b-aa8d-3f03d6964e945
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 PackPSN46fd5feb-66c5-4f3b-aa8d-3f03d6964e945
748797inert 1 MG Oral TabletPSN46fd5feb-66c5-4f3b-aa8d-3f03d6964e945
310463norethindrone 0.5 MG / ethinyl estradiol 0.035 MG Oral TabletPSN46fd5feb-66c5-4f3b-aa8d-3f03d6964e945
392662norethindrone 0.75 MG / ethinyl estradiol 0.035 MG Oral TabletPSN46fd5feb-66c5-4f3b-aa8d-3f03d6964e945
312033norethindrone acetate 1 MG / ethinyl estradiol 35 MCG Oral TabletPSN46fd5feb-66c5-4f3b-aa8d-3f03d6964e945
310463ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral TabletSCD46fd5feb-66c5-4f3b-aa8d-3f03d6964e945
392662ethinyl estradiol 0.035 MG / norethindrone 0.75 MG Oral TabletSCD46fd5feb-66c5-4f3b-aa8d-3f03d6964e945
312033ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral TabletSCD46fd5feb-66c5-4f3b-aa8d-3f03d6964e945
748797inert ingredients 1 MG Oral TabletSCD46fd5feb-66c5-4f3b-aa8d-3f03d6964e945
1242787Alyacen 7/7/7 28-Day KitSY46fd5feb-66c5-4f3b-aa8d-3f03d6964e945
1242787Alyacen 7/7/7 KitSY46fd5feb-66c5-4f3b-aa8d-3f03d6964e945
310463ethinyl estradiol 35 MCG / norethindrone 0.5 MG Oral TabletSY46fd5feb-66c5-4f3b-aa8d-3f03d6964e945
392662ethinyl estradiol 35 MCG / norethindrone 0.75 MG Oral TabletSY46fd5feb-66c5-4f3b-aa8d-3f03d6964e945
312033ethinyl estradiol 35 MCG / norethindrone 1 MG Oral TabletSY46fd5feb-66c5-4f3b-aa8d-3f03d6964e945

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-556-29684620556293 BLISTER PACK in 1 CARTON (68462-556-29) / 1 KIT in 1 BLISTER PACK (68462-556-84) 3 blister pack2012-01-190000-00-00NoNoCurrent
68462-556-84684620556841 in 1 BLISTER PACKHistorical