FDA.reportPublic FDA data

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

Product NDC
0378-7274
11-digit product format
003787274
Labeler code
0378
Product ID
0378-7274_8a7faa9f-224f-fb2e-fde2-986d2142dc2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
norethindrone acetate and ethinyl estradiol
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA202770
Marketing category
ANDA
Marketing start
2019-09-25
Substance
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Active strength
.03; 1.5 mg/1; mg/1
Pharmacologic classes
Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [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
A202770-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; NORETHINDRONE ACETATE0.03MG;1.5MGTABLET / ORAL-21AB2015-02-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202770-001AB

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 22:54:322026-06A202770-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.03MG;1.5MGTABLET / ORAL-21AB2015-02-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202770-001AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LUIZZA 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLXiromed LLCb1c3e33d-ec95-cd89-7ad9-36994c802a1f2025-02-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202770
application number: ANDA202770
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.3108a9bc-3378-459d-8f6b-bd5eff2ad6572024-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202770
application number: ANDA202770
ndc (product): 0378-7274

Additional Listing Data#

Finished product
Yes
Brand name base
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3108a9bc-3378-459d-8f6b-bd5eff2ad657Available 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
0378-7274-53NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL3 in 1 CARTONTABLET36
0378-7274-85NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL1 in 1 POUCHTABLET16
0378-7274-85NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL21 in 1 BLISTER PACKTABLET216

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-7274-53EA - Each0378-727469756ed9-63ef-4c23-95dd-81b86ce817fa12019-10-07
0378-7274-85EA - Each0378-7274c7bd30bf-48a1-49ec-82af-d4d2f591715612019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-7274NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [MYLAN PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 3 package rows20250221_3108a9bc-3378-459d-8f6b-bd5eff2ad657.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1359028{21 (ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet) } PackGPCK3108a9bc-3378-459d-8f6b-bd5eff2ad6576
1359028Eth estra-Noreth Ac 0.03-1.5 MG (21) Oral Tablet 21 Day PackPSN3108a9bc-3378-459d-8f6b-bd5eff2ad6576
1359022norethindrone acetate 1.5 MG / ethinyl estradiol 30 MCG Oral TabletPSN3108a9bc-3378-459d-8f6b-bd5eff2ad6576
1359022ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral TabletSCD3108a9bc-3378-459d-8f6b-bd5eff2ad6576
1359022ethinyl estradiol 30 MCG / norethindrone acetate 1.5 MG Oral TabletSY3108a9bc-3378-459d-8f6b-bd5eff2ad6576

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-7274-53003787274533 POUCH in 1 CARTON (0378-7274-53) / 1 BLISTER PACK in 1 POUCH (0378-7274-85) / 21 TABLET in 1 BLISTER PACK3 pouch2019-09-250000-00-00NoNoCurrent
0378-7274-85003787274851 in 1 POUCHHistorical