Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate

Product NDC
60219-1031
11-digit product format
602191031
Labeler code
60219
Product ID
60219-1031_ae13db8f-27e2-420a-b909-99d0347e6286
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
Dosage form
KIT
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA207514
Marketing category
ANDA
Marketing start
2017-09-21
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui259176, 1358762, 1359117, 1426288

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
60219-1031-6Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate1 in 1 BLISTER PACKKIT113
60219-1031-7Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate3 in 1 CARTONKIT313

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60219-1031NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE KIT [AMNEAL PHARMACEUTICALS NY LLC]13Current NDC, Legacy NDC, 2 package rows20230825_d4fa03d8-0ae0-497f-ba4e-76f03fd7a3ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1359117{24 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet) / 4 (ferrous fumarate 75 MG Oral Tablet) } PackGPCKd4fa03d8-0ae0-497f-ba4e-76f03fd7a3ab13
1359117Eth estra-Noreth Ac 0.02-1 MG (24) Oral Tablet / Ferr fum 75 MG (4) Oral Tablet 28 Day PackPSNd4fa03d8-0ae0-497f-ba4e-76f03fd7a3ab13
259176ferrous fumarate 75 MG Oral TabletPSNd4fa03d8-0ae0-497f-ba4e-76f03fd7a3ab13
1358762norethindrone acetate 1 MG / ethinyl estradiol 0.02 MG Oral TabletPSNd4fa03d8-0ae0-497f-ba4e-76f03fd7a3ab13
1426288norethindrone acetate 1 MG / ethinyl estradiol 20 MCG Chewable TabletPSNd4fa03d8-0ae0-497f-ba4e-76f03fd7a3ab13
1426288ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Chewable TabletSCDd4fa03d8-0ae0-497f-ba4e-76f03fd7a3ab13
1358762ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral TabletSCDd4fa03d8-0ae0-497f-ba4e-76f03fd7a3ab13
259176ferrous fumarate 75 MG Oral TabletSCDd4fa03d8-0ae0-497f-ba4e-76f03fd7a3ab13
1359117ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet / ferrous fumarate 75 MG Oral Tablet 28 day PackSYd4fa03d8-0ae0-497f-ba4e-76f03fd7a3ab13
1426288ethinyl estradiol 20 MCG / norethindrone acetate 1 MG Chewable TabletSYd4fa03d8-0ae0-497f-ba4e-76f03fd7a3ab13
1358762ethinyl estradiol 20 MCG / norethindrone acetate 1 MG Oral TabletSYd4fa03d8-0ae0-497f-ba4e-76f03fd7a3ab13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60219-1031-6602191031061 in 1 BLISTER PACKHistorical
60219-1031-7602191031073 BLISTER PACK in 1 CARTON (60219-1031-7) / 1 KIT in 1 BLISTER PACK (60219-1031-6) 3 blister pack2017-09-210000-00-00NoNoCurrent