Her Style

Product NDC
50742-352
11-digit product format
507420352
Labeler code
50742
Product ID
50742-352_9ebc666c-47b1-477a-a9e0-8a761b809ccc
Type
HUMAN OTC DRUG
Nonproprietary name
levonorgestrel
Dosage form
TABLET
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA207976
Marketing category
ANDA
Marketing start
2022-11-30
Substance
LEVONORGESTREL
Active strength
1.5 mg/1
Pharmacologic classes
Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine System [EPC]
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 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
A207976-001HER STYLELEVONORGESTREL1.5MGTABLET / ORAL2016-03-11

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-1187673890dc5c…
2021-03-12 10:30 UTC2021-03A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-113f01610625f2…
2019-09-15 20:21 UTC2019-09A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-11b00525d2431f…
2019-07-19 19:46 UTC2019-07A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-113f0d92c62455…
2023-05-13 08:27 UTC2023-05A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-11053a50430f4f…
2023-01-26 05:58 UTC2023-01A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207976-001HER STYLE1.5MGTABLET / ORAL2016-03-11cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Her Style
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVONORGESTREL1.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5W7SIA7YZWInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
483325Internal RxNorm lookup
1855519Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6e631755-b7c5-4a3a-b46d-f66b4ceedb1cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8511fc19-172b-4e1f-90ec-2f09c85b16deProduct name220250116
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50Product name320230718
fa479cfe-0bd0-7366-d57a-92f3682e87c5Product name320210518
20e1a411-dba8-4afa-b9f9-1205d5b0bde9Product name320210513
5956a0e2-c373-452c-bdcf-c93d354432efProduct name120200714
ca306105-d51c-4821-9ec1-8eec753d073dProduct name120200619
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4dProduct name720190612
f92411e4-13dd-7baf-106e-9b3fcf758c39Product name420190502
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
f713a022-3e1c-4035-bc91-62131bc80b42Product name220190125
79d5025d-8129-440a-b861-6df2d2661609Product name320180607
d871c48c-6b0b-4203-b55d-72ead21ea7adProduct name520180419
12434b90-2738-45d5-9e1b-55001e853273Product name220171122
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
741e98f2-ac6c-4d80-9ca8-c663c171ba1dProduct name120161121
cc765024-f257-4c67-b780-c356aadd6980Product name320150902
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5a9b579b-8431-5b3a-2ba4-86556704f873Product name120140508
5f44c957-835a-ada0-662f-5b1071b7a68bProduct name120140508
d03a75af-b11b-673b-268b-318050d0b3bdProduct name120140508
d0cc7d42-77a7-b452-c6c3-a162fa11225fProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
e5ccd419-1745-560a-1e25-c6e3941c710aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50742-352-01Her Style1 in 1 CARTONTABLET13
50742-352-01Her Style1 in 1 BLISTER PACKTABLET13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-352-01EA - Each50742-352c66db837-30ab-4675-af66-60bedbc0d86b12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-352HER STYLE (LEVONORGESTREL) TABLET [INGENUS PHARMACEUTICALS, LLC]2Current NDC, Legacy NDC, 2 package rows20221221_6e631755-b7c5-4a3a-b46d-f66b4ceedb1c.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Her StyleLEVONORGESTRELIngenus Pharmaceuticals, LLC6e631755-b7c5-4a3a-b46d-f66b4ceedb1c2025-12-05WarningsExact identifier
application applno (ANDA): 207976
application number: ANDA207976
ndc (product): 50742-352
New DayLEVONORGESTRELNorthstar Rx LLC9e8c96f6-ab51-4721-b276-1ca02a7125102025-12-05WarningsExact identifier
application applno (ANDA): 207976
application number: ANDA207976

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1855519Her Style 1.5 MG Oral TabletPSN6e631755-b7c5-4a3a-b46d-f66b4ceedb1c3
483325levonorgestrel 1.5 MG Oral TabletPSN6e631755-b7c5-4a3a-b46d-f66b4ceedb1c3
1855519levonorgestrel 1.5 MG Oral Tablet [Her Style]SBD6e631755-b7c5-4a3a-b46d-f66b4ceedb1c3
483325levonorgestrel 1.5 MG Oral TabletSCD6e631755-b7c5-4a3a-b46d-f66b4ceedb1c3
1855519Her Style 1.5 MG Oral TabletSY6e631755-b7c5-4a3a-b46d-f66b4ceedb1c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50742-352-01507420352011 BLISTER PACK in 1 CARTON (50742-352-01) / 1 TABLET in 1 BLISTER PACK1 blister pack2022-11-300000-00-00NoNoCurrent