FDA.reportPublic FDA data

Norethindrone Acetate and Ethinyl Estradiol

Product NDC
68462-657
11-digit product format
684620657
Labeler code
68462
Product ID
68462-657_bc4774d0-9902-4678-af65-69d6a70d9983
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norethindrone Acetate and Ethinyl Estradiol
Dosage form
TABLET
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA203038
Marketing category
ANDA
Marketing start
2015-04-02
Substance
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Active strength
5; 1 ug/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 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203038-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; NORETHINDRONE ACETATE0.0025MG;0.5MGTABLET / ORALAB2015-04-02
A203038-002NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; NORETHINDRONE ACETATE0.005MG;1MGTABLET / ORALAB2015-04-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A203038-001AB
A203038-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203038-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.0025MG;0.5MGTABLET / ORALAB2015-04-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203038-002NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.005MG;1MGTABLET / ORALAB2015-04-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203038-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.0025MG;0.5MGTABLET / ORALAB2015-04-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203038-002NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.005MG;1MGTABLET / ORALAB2015-04-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A203038-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.0025MG;0.5MGTABLET / ORALAB2015-04-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203038-002NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.005MG;1MGTABLET / ORALAB2015-04-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203038-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.0025MG;0.5MGTABLET / ORALAB2015-04-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203038-002NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.005MG;1MGTABLET / ORALAB2015-04-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203038-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.0025MG;0.5MGTABLET / ORALAB2015-04-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203038-002NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.005MG;1MGTABLET / ORALAB2015-04-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203038-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.0025MG;0.5MGTABLET / ORALAB2015-04-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203038-002NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.005MG;1MGTABLET / ORALAB2015-04-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203038-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.0025MG;0.5MGTABLET / ORALAB2015-04-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203038-002NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.005MG;1MGTABLET / ORALAB2015-04-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203038-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.0025MG;0.5MGTABLET / ORALAB2015-04-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203038-002NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.005MG;1MGTABLET / ORALAB2015-04-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203038-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.0025MG;0.5MGTABLET / ORALAB2015-04-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203038-002NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.005MG;1MGTABLET / ORALAB2015-04-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203038-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.0025MG;0.5MGTABLET / ORALAB2015-04-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A203038-002NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.005MG;1MGTABLET / ORALAB2015-04-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203038-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.0025MG;0.5MGTABLET / ORALAB2015-04-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203038-002NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.005MG;1MGTABLET / ORALAB2015-04-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203038-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.0025MG;0.5MGTABLET / ORALAB2015-04-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203038-002NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.005MG;1MGTABLET / ORALAB2015-04-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203038-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.0025MG;0.5MGTABLET / ORALAB2015-04-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203038-002NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.005MG;1MGTABLET / ORALAB2015-04-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203038-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.0025MG;0.5MGTABLET / ORALAB2015-04-028072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203038-002NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.005MG;1MGTABLET / ORALAB2015-04-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203038-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.0025MG;0.5MGTABLET / ORALAB2015-04-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203038-002NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.005MG;1MGTABLET / ORALAB2015-04-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203038-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.0025MG;0.5MGTABLET / ORALAB2015-04-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203038-002NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.005MG;1MGTABLET / ORALAB2015-04-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203038-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.0025MG;0.5MGTABLET / ORALAB2015-04-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203038-002NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.005MG;1MGTABLET / ORALAB2015-04-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203038-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.0025MG;0.5MGTABLET / ORALAB2015-04-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203038-002NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.005MG;1MGTABLET / ORALAB2015-04-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203038-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.0025MG;0.5MGTABLET / ORALAB2015-04-02bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203038-002NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.005MG;1MGTABLET / ORALAB2015-04-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203038-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.0025MG;0.5MGTABLET / ORALAB2015-04-02782e0a99824c…
2021-12-28 21:50 UTC2021-12A203038-002NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.005MG;1MGTABLET / ORALAB2015-04-02782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203038-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203038-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203038-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203038-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203038-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203038-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203038-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203038-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203038-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203038-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203038-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203038-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203038-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203038-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203038-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203038-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203038-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203038-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203038-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203038-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203038-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203038-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203038-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203038-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203038-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203038-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203038-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203038-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203038-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203038-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203038-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203038-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203038-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203038-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203038-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203038-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203038-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203038-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203038-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203038-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Norethindrone Acetate and Ethinyl Estradiol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NORETHINDRONE ACETATE5 ug/1
ETHINYL ESTRADIOL1 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1090992Internal RxNorm lookup
1251323Internal RxNorm lookup
1251334Internal RxNorm lookup
1251336Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cf549b5a-2707-4020-9f94-dab1260e1664Available 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
68462-657-29Norethindrone Acetate and Ethinyl Estradiol1 in 1 POUCHTABLET16
68462-657-29Norethindrone Acetate and Ethinyl Estradiol3 in 1 CARTONTABLET36
68462-657-90Norethindrone Acetate and Ethinyl Estradiol90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-657-29EA - Each68462-6578724191a-2077-45db-93b8-a546b5af62c812015-06-09
68462-657-90EA - Each68462-657f82c8c12-97aa-4aa9-aee6-ae7502bf4a2e12015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA]1
NORETHINDRONE ACETATEACTIVE INGREDIENT9S44LIC7OJNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA]1
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA]1
NORETHINDRONEACTIVE MOIETYT18F433X4SNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA]1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-657NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA]5Current NDC, Legacy NDC, 3 package rows20231202_cf549b5a-2707-4020-9f94-dab1260e1664.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
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USAcf549b5a-2707-4020-9f94-dab1260e16642026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203038
application number: ANDA203038
ndc (product): 68462-657

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1251334{28 (ethinyl estradiol 0.0025 MG / norethindrone acetate 0.5 MG Oral Tablet) } PackGPCKcf549b5a-2707-4020-9f94-dab1260e16646
1251336{28 (ethinyl estradiol 0.005 MG / norethindrone acetate 1 MG Oral Tablet) } PackGPCKcf549b5a-2707-4020-9f94-dab1260e16646
1251334Eth estra-Noreth Ac 0.0025-0.5 MG (28) Oral Tablet 28 Day PackPSNcf549b5a-2707-4020-9f94-dab1260e16646
1251336Eth estra-Noreth Ac 0.005-1 MG (28) Oral Tablet 28 Day PackPSNcf549b5a-2707-4020-9f94-dab1260e16646
1251323norethindrone acetate 0.5 MG / ethinyl estradiol 2.5 MCG Oral TabletPSNcf549b5a-2707-4020-9f94-dab1260e16646
1090992norethindrone acetate 1 MG / ethinyl estradiol 5 MCG Oral TabletPSNcf549b5a-2707-4020-9f94-dab1260e16646
1251323ethinyl estradiol 0.0025 MG / norethindrone acetate 0.5 MG Oral TabletSCDcf549b5a-2707-4020-9f94-dab1260e16646
1090992ethinyl estradiol 0.005 MG / norethindrone acetate 1 MG Oral TabletSCDcf549b5a-2707-4020-9f94-dab1260e16646
1251323ethinyl estradiol 2.5 MCG / norethindrone acetate 500 MCG Oral TabletSYcf549b5a-2707-4020-9f94-dab1260e16646
1090992ethinyl estradiol 5 MCG / norethindrone acetate 1 MG Oral TabletSYcf549b5a-2707-4020-9f94-dab1260e16646

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-657-29684620657293 POUCH in 1 CARTON (68462-657-29) / 1 BLISTER PACK in 1 POUCH / 28 TABLET in 1 BLISTER PACK3 pouch2015-04-020000-00-00NoNoCurrent
68462-657-906846206579090 TABLET in 1 BOTTLE (68462-657-90) 90 tablet2015-04-020000-00-00NoNoCurrent