FDA.reportPublic FDA data

Mono-Linyah

Product NDC
16714-360
11-digit product format
167140360
Labeler code
16714
Product ID
16714-360_e9022492-18a7-44e1-9a89-45a4c06c72f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
norgestimate and ethinyl estradiol
Dosage form
KIT
Labeler
Northstar Rx LLC
Application
ANDA090523
Marketing category
ANDA
Marketing start
2012-05-23
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 42.

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
A090523-001MONO-LINYAHETHINYL ESTRADIOL; NORGESTIMATE0.035MG;0.25MGTABLET / ORAL-28AB2012-05-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090523-001AB

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-233f01610625f2…
2019-09-15 20:21 UTC2019-09A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090523-001MONO-LINYAH0.035MG;0.25MGTABLET / ORAL-28AB2012-05-23e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A090523-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090523-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090523-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090523-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090523-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090523-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090523-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090523-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090523-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090523-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090523-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090523-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090523-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090523-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090523-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090523-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090523-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090523-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090523-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090523-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090523-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090523-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090523-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090523-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090523-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090523-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090523-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090523-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090523-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090523-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090523-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090523-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090523-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090523-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090523-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090523-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090523-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090523-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090523-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090523-001AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Mono-Linyah
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
240128Internal RxNorm lookup
748797Internal RxNorm lookup
749860Internal RxNorm lookup
1365899Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
84a20017-344b-4684-a915-c85a55fcbbcbAvailable 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
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
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3Product name120140508
d0cc7d42-77a7-b452-c6c3-a162fa11225fProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-360-01Mono-Linyah1 in 1 BLISTER PACKKIT19
16714-360-01Mono-Linyah1 in 1 PACKETKIT19
16714-360-02Mono-Linyah1 in 1 CARTONKIT19
16714-360-02Mono-Linyah1 in 1 BLISTER PACKKIT19
16714-360-03Mono-Linyah1 in 1 BLISTER PACKKIT19
16714-360-03Mono-Linyah3 in 1 CARTONKIT39
16714-360-04Mono-Linyah1 in 1 BLISTER PACKKIT19
16714-360-04Mono-Linyah6 in 1 CARTONKIT69

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-360-01EA - Each16714-360734e4ef8-970e-434a-bb43-7c5de42a81fc12013-05-02
16714-360-04EA - Each16714-360fde400a2-fcb0-4c88-89ba-a722fe479fde12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UMONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
NORGESTIMATEACTIVE INGREDIENTC291HFX4DYMONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UMONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
NORGESTIMATEACTIVE MOIETYC291HFX4DYMONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62MONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEMONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PMONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990MONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UMONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
TRIACETININACTIVE INGREDIENTXHX3C3X673MONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-360MONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]9Current NDC, Legacy NDC, 8 package rows20250327_84a20017-344b-4684-a915-c85a55fcbbcb.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
MONO-LINYAHNORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutions2ec8f18f-297c-405f-b191-a40767366bad2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090523
application number: ANDA090523
Mono-LinyahNORGESTIMATE AND ETHINYL ESTRADIOLNorthstar Rx LLC84a20017-344b-4684-a915-c85a55fcbbcb2025-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090523
application number: ANDA090523
ndc (product): 16714-360
NymyoNORGESTIMATE AND ETHINYL ESTRADIOLMayne Pharma Inc.a522aff5-b02f-4e18-bf59-40bb0399e6fe2022-12-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090523
application number: ANDA090523

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1365899{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Mono-Linyah 28 Day]BPCK84a20017-344b-4684-a915-c85a55fcbbcb9
749860{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK84a20017-344b-4684-a915-c85a55fcbbcb9
749860Eth estra-Norgestim 0.035-0.25 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN84a20017-344b-4684-a915-c85a55fcbbcb9
748797inert 1 MG Oral TabletPSN84a20017-344b-4684-a915-c85a55fcbbcb9
1365899MONO-LINYAH 28 Day PackPSN84a20017-344b-4684-a915-c85a55fcbbcb9
240128norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral TabletPSN84a20017-344b-4684-a915-c85a55fcbbcb9
240128ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral TabletSCD84a20017-344b-4684-a915-c85a55fcbbcb9
748797inert ingredients 1 MG Oral TabletSCD84a20017-344b-4684-a915-c85a55fcbbcb9
240128ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral TabletSY84a20017-344b-4684-a915-c85a55fcbbcb9
1365899Mono-Linyah 28 Day PackSY84a20017-344b-4684-a915-c85a55fcbbcb9
1365899{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Mono-Linyah 28 Day]BPCK2ec8f18f-297c-405f-b191-a40767366bad6
749860{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK2ec8f18f-297c-405f-b191-a40767366bad6
749860Eth estra-Norgestim 0.035-0.25 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN2ec8f18f-297c-405f-b191-a40767366bad6
748797inert 1 MG Oral TabletPSN2ec8f18f-297c-405f-b191-a40767366bad6
1365899MONO-LINYAH 28 Day PackPSN2ec8f18f-297c-405f-b191-a40767366bad6
240128norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral TabletPSN2ec8f18f-297c-405f-b191-a40767366bad6
240128ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral TabletSCD2ec8f18f-297c-405f-b191-a40767366bad6
748797inert ingredients 1 MG Oral TabletSCD2ec8f18f-297c-405f-b191-a40767366bad6
240128ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral TabletSY2ec8f18f-297c-405f-b191-a40767366bad6
1365899Mono-Linyah 28 Day PackSY2ec8f18f-297c-405f-b191-a40767366bad6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-360-01167140360011 BLISTER PACK in 1 PACKET (16714-360-01) / 1 KIT in 1 BLISTER PACK1 blister pack2012-05-230000-00-00NoNoCurrent
16714-360-02167140360021 BLISTER PACK in 1 CARTON (16714-360-02) / 1 KIT in 1 BLISTER PACK1 blister pack2012-05-230000-00-00NoNoCurrent
16714-360-03167140360033 BLISTER PACK in 1 CARTON (16714-360-03) / 1 KIT in 1 BLISTER PACK3 blister pack2012-05-230000-00-00NoNoCurrent
16714-360-04167140360046 BLISTER PACK in 1 CARTON (16714-360-04) / 1 KIT in 1 BLISTER PACK6 blister pack2012-05-230000-00-00NoNoCurrent