FDA.reportPublic FDA data

Norethindrone Acetate and Ethinyl Estradiol

Product NDC
68462-656
11-digit product format
684620656
Labeler code
68462
Product ID
68462-656_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
2.5; .5 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…

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 · 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): 68462-656

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 ACETATE2.5 ug/1
ETHINYL ESTRADIOL.5 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
68462-656-29Norethindrone Acetate and Ethinyl Estradiol3 in 1 CARTONTABLET36
68462-656-29Norethindrone Acetate and Ethinyl Estradiol1 in 1 POUCHTABLET16
68462-656-90Norethindrone Acetate and Ethinyl Estradiol90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-656-29EA - Each68462-656a4dc6393-e843-4322-95e2-03721a58acf712015-06-09

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
68462-656NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA]5Current NDC, Legacy NDC, 3 package rows20231202_cf549b5a-2707-4020-9f94-dab1260e1664.zip

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
68462-656-29684620656293 POUCH in 1 CARTON (68462-656-29) / 1 BLISTER PACK in 1 POUCH / 28 TABLET in 1 BLISTER PACK3 pouch2015-04-020000-00-00NoNoCurrent
68462-656-906846206569090 TABLET in 1 BOTTLE (68462-656-90) 90 tablet2015-04-020000-00-00NoNoCurrent