FDA.reportPublic FDA data

Loestrin

Product NDC
51285-128
11-digit product format
512850128
Labeler code
51285
Product ID
51285-128_21f0dbf2-f0a8-447a-a975-482b4194b1eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
Dosage form
KIT
Labeler
Teva Women's Health LLC
Application
ANDA076064
Marketing category
ANDA
Marketing start
2015-02-26
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Loestrin
Brand name suffix
Fe 28 Day
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9S44LIC7OJ, 423D2T571U
Rxcui259176, 1358762, 1358763, 1358770, 1358776, 1358781, 1359022, 1359023, 1359026, 1359028, 1359031

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
51285-128-70LoestrinFe 28 Day1 in 1 POUCHKIT112
51285-128-70LoestrinFe 28 Day5 in 1 CARTONKIT512

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51285-128LOESTRIN 21 DAY (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET LOESTRIN FE 28 DAY (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA WOMEN'S HEALTH LLC]12Current NDC, Legacy NDC, 2 package rows20250416_f29ebcb5-7e65-4092-bfaa-f5ec026fc255.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1358781{21 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet) } Pack [Loestrin 1/20 21 Day]BPCKf29ebcb5-7e65-4092-bfaa-f5ec026fc25512
1358770{21 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet) / 7 (ferrous fumarate 75 MG Oral Tablet) } Pack [Loestrin Fe 1/20 28 Day]BPCKf29ebcb5-7e65-4092-bfaa-f5ec026fc25512
1359031{21 (ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet) } Pack [Loestrin 1.5/30 21 Day]BPCKf29ebcb5-7e65-4092-bfaa-f5ec026fc25512
1359026{21 (ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet) / 7 (ferrous fumarate 75 MG Oral Tablet) } Pack [Loestrin Fe 1.5/30 28 Day]BPCKf29ebcb5-7e65-4092-bfaa-f5ec026fc25512
1358776{21 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet) } PackGPCKf29ebcb5-7e65-4092-bfaa-f5ec026fc25512
1358763{21 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet) / 7 (ferrous fumarate 75 MG Oral Tablet) } PackGPCKf29ebcb5-7e65-4092-bfaa-f5ec026fc25512
1359028{21 (ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet) } PackGPCKf29ebcb5-7e65-4092-bfaa-f5ec026fc25512
1359023{21 (ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet) / 7 (ferrous fumarate 75 MG Oral Tablet) } PackGPCKf29ebcb5-7e65-4092-bfaa-f5ec026fc25512
1358776Eth estra-Noreth Ac 0.02-1 MG (21) Oral Tablet 21 Day PackPSNf29ebcb5-7e65-4092-bfaa-f5ec026fc25512
1359023Eth estra-Noreth Ac 0.03-1.5 MG (21) Oral Tablet / Ferr fum 75 MG (7) Oral Tablet 28 Day PackPSNf29ebcb5-7e65-4092-bfaa-f5ec026fc25512
1359028Eth estra-Noreth Ac 0.03-1.5 MG (21) Oral Tablet 21 Day PackPSNf29ebcb5-7e65-4092-bfaa-f5ec026fc25512
1358763Eth-estra-Noreth Ac 0.02-1 MG (21) Oral Tablet / Ferr fum 75 MG (7) Oral Tablet 28 Day PackPSNf29ebcb5-7e65-4092-bfaa-f5ec026fc25512
259176ferrous fumarate 75 MG Oral TabletPSNf29ebcb5-7e65-4092-bfaa-f5ec026fc25512
1359031LOESTRIN 1.5/30 21 Day PackPSNf29ebcb5-7e65-4092-bfaa-f5ec026fc25512
1358781LOESTRIN 1/20 21 Day PackPSNf29ebcb5-7e65-4092-bfaa-f5ec026fc25512
1359026LOESTRIN Fe 1.5/30 28 Day PackPSNf29ebcb5-7e65-4092-bfaa-f5ec026fc25512
1358770LOESTRIN Fe 1/20 28 Day PackPSNf29ebcb5-7e65-4092-bfaa-f5ec026fc25512
1358762norethindrone acetate 1 MG / ethinyl estradiol 0.02 MG Oral TabletPSNf29ebcb5-7e65-4092-bfaa-f5ec026fc25512
1359022norethindrone acetate 1.5 MG / ethinyl estradiol 30 MCG Oral TabletPSNf29ebcb5-7e65-4092-bfaa-f5ec026fc25512
1358762ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral TabletSCDf29ebcb5-7e65-4092-bfaa-f5ec026fc25512
1359022ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral TabletSCDf29ebcb5-7e65-4092-bfaa-f5ec026fc25512
259176ferrous fumarate 75 MG Oral TabletSCDf29ebcb5-7e65-4092-bfaa-f5ec026fc25512
1358762ethinyl estradiol 20 MCG / norethindrone acetate 1 MG Oral TabletSYf29ebcb5-7e65-4092-bfaa-f5ec026fc25512
1359022ethinyl estradiol 30 MCG / norethindrone acetate 1.5 MG Oral TabletSYf29ebcb5-7e65-4092-bfaa-f5ec026fc25512
1359031Loestrin 1.5/30 21 Day PackSYf29ebcb5-7e65-4092-bfaa-f5ec026fc25512
1358781Loestrin 1/20 21 Day PackSYf29ebcb5-7e65-4092-bfaa-f5ec026fc25512
1359026Loestrin Fe 1.5/30 28 Day PackSYf29ebcb5-7e65-4092-bfaa-f5ec026fc25512
1358770Loestrin Fe 1/20 28 Day PackSYf29ebcb5-7e65-4092-bfaa-f5ec026fc25512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51285-128-70512850128705 POUCH in 1 CARTON (51285-128-70) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK5 pouch2015-02-260000-00-00NoNoCurrent