FDA.reportPublic FDA data

Hailey 1.5/30

Product NDC
68462-504
11-digit product format
684620504
Labeler code
68462
Product ID
68462-504_299fb286-ee60-4950-8315-d310c6ce29cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norethindrone Acetate and Ethinyl Estradiol
Dosage form
TABLET
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA209297
Marketing category
ANDA
Marketing start
2018-06-05
Substance
NORETHINDRONE ACETATE; ETHINYL ESTRADIOL
Active strength
1.5; .03 mg/1; mg/1
Pharmacologic classes
Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
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 43.

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
A209297-001HAILEY 1.5/30ETHINYL ESTRADIOL; NORETHINDRONE ACETATE0.03MG;1.5MGTABLET / ORAL-21AB2018-06-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209297-001AB

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-0584e616aacf4f…
2026-08-18 06:07:402026-07A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-053f01610625f2…
2019-09-15 20:21 UTC2019-09A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209297-001HAILEY 1.5/300.03MG;1.5MGTABLET / ORAL-21AB2018-06-05f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A209297-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A209297-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209297-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209297-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209297-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209297-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209297-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209297-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209297-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209297-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209297-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209297-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209297-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209297-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209297-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209297-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209297-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209297-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209297-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209297-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209297-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209297-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209297-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A209297-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209297-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209297-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209297-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A209297-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A209297-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209297-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209297-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209297-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209297-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209297-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209297-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209297-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A209297-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A209297-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209297-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209297-001AB1f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Hailey 1.5/30
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NORETHINDRONE ACETATE1.5 mg/1
ETHINYL ESTRADIOL.03 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9S44LIC7OJInternal UNII lookup
423D2T571UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1359022Internal RxNorm lookup
1359028Internal RxNorm lookup
2047760Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
021df70a-0c37-4237-a2f7-2597ff6d41f5Available 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
68462-504-79Hailey 1.5/301 in 1 POUCHTABLET19
68462-504-79Hailey 1.5/3021 in 1 BLISTER PACKTABLET219
68462-504-81Hailey 1.5/303 in 1 CARTONTABLET39

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-504-79EA - Each68462-504e3a985a8-5580-4522-ae5e-d04a25944c9112019-09-05
68462-504-81EA - Each68462-504130f517b-af28-4ae1-ad38-004a57aec00112019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-504HAILEY 1.5/30 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [GLENMARK PHARMACEUTICALS INC., USA]8Current NDC, Legacy NDC, 3 package rows20240612_021df70a-0c37-4237-a2f7-2597ff6d41f5.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hailey 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA021df70a-0c37-4237-a2f7-2597ff6d41f52026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209297
application number: ANDA209297
ndc (product): 68462-504

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2047760{21 (ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet) } Pack [Hailey 1.5/30 21 Day]BPCK021df70a-0c37-4237-a2f7-2597ff6d41f59
1359028{21 (ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet) } PackGPCK021df70a-0c37-4237-a2f7-2597ff6d41f59
1359028Eth estra-Noreth Ac 0.03-1.5 MG (21) Oral Tablet 21 Day PackPSN021df70a-0c37-4237-a2f7-2597ff6d41f59
2047760Hailey 1.5/30 21 Day PackPSN021df70a-0c37-4237-a2f7-2597ff6d41f59
1359022norethindrone acetate 1.5 MG / ethinyl estradiol 30 MCG Oral TabletPSN021df70a-0c37-4237-a2f7-2597ff6d41f59
1359022ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral TabletSCD021df70a-0c37-4237-a2f7-2597ff6d41f59
1359022ethinyl estradiol 30 MCG / norethindrone acetate 1.5 MG Oral TabletSY021df70a-0c37-4237-a2f7-2597ff6d41f59
2047760Hailey 1.5/30 21 Day PackSY021df70a-0c37-4237-a2f7-2597ff6d41f59

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-504-79684620504791 in 1 POUCHHistorical
68462-504-81684620504813 POUCH in 1 CARTON (68462-504-81) / 1 BLISTER PACK in 1 POUCH (68462-504-79) / 21 TABLET in 1 BLISTER PACK3 pouch2018-06-050000-00-00NoNoCurrent