FDA.reportPublic FDA data

Nortrel

Product NDC
0555-9008
11-digit product format
005559008
Labeler code
0555
Product ID
0555-9008_9ac007e4-792d-4122-8daf-456dea28f82f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norethindrone and Ethinyl Estradiol
Dosage form
KIT
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA072695
Marketing category
ANDA
Marketing start
2001-06-06
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nortrel
Brand name suffix
28 Day
Listing expiration
2027-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Unii423D2T571U, T18F433X4S
Rxcui310463, 312033, 748797, 749858, 749869, 749879, 751868, 751870, 751871

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
0555-9008-67Nortrel28 Day3 in 1 CARTONKIT316
0555-9008-79Nortrel28 Day1 in 1 POUCHKIT116
0555-9008-79Nortrel28 Day1 in 1 BLISTER PACKKIT116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-9008-67EA - Each0555-900834fc15b2-cdf1-4e46-b477-a4b50130df1d12012-07-24
0555-9008-79EA - Each0555-900827f3edd1-72c3-41f7-bb73-91a051b8b23712017-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UNORTREL (21 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) TABLET NORTREL (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
NORETHINDRONEACTIVE INGREDIENTT18F433X4SNORTREL (21 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) TABLET NORTREL (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UNORTREL (21 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) TABLET NORTREL (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
NORETHINDRONEACTIVE MOIETYT18F433X4SNORTREL (21 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) TABLET NORTREL (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933NORTREL (21 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) TABLET NORTREL (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNORTREL (21 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) TABLET NORTREL (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNORTREL (21 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) TABLET NORTREL (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NORTREL (21 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) TABLET NORTREL (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNORTREL (21 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) TABLET NORTREL (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-9008NORTREL 21 DAY (NORETHINDRONE AND ETHINYL ESTRADIOL) TABLET NORTREL 28 DAY (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.]15Current NDC, Legacy NDC, 3 package rows20250316_140c50d6-c931-423a-9aa0-526eae7ab93c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
751868{21 (ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Nortrel 0.5/35 28 Day]BPCK140c50d6-c931-423a-9aa0-526eae7ab93c16
751871{21 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) } Pack [Nortrel 1/35 21 Day]BPCK140c50d6-c931-423a-9aa0-526eae7ab93c16
751870{21 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Nortrel 1/35 28 Day]BPCK140c50d6-c931-423a-9aa0-526eae7ab93c16
749879{21 (ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK140c50d6-c931-423a-9aa0-526eae7ab93c16
749869{21 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) } PackGPCK140c50d6-c931-423a-9aa0-526eae7ab93c16
749858{21 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK140c50d6-c931-423a-9aa0-526eae7ab93c16
749869Eth estra-Noreth 0.0.35-1 MG (21) Oral Tablet 21 Day PackPSN140c50d6-c931-423a-9aa0-526eae7ab93c16
749879Eth estra-Noreth 0.035-0.5 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN140c50d6-c931-423a-9aa0-526eae7ab93c16
749858Eth estra-Noreth 0.035-1 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN140c50d6-c931-423a-9aa0-526eae7ab93c16
748797inert 1 MG Oral TabletPSN140c50d6-c931-423a-9aa0-526eae7ab93c16
310463norethindrone 0.5 MG / ethinyl estradiol 0.035 MG Oral TabletPSN140c50d6-c931-423a-9aa0-526eae7ab93c16
312033norethindrone acetate 1 MG / ethinyl estradiol 35 MCG Oral TabletPSN140c50d6-c931-423a-9aa0-526eae7ab93c16
751868Nortrel 0.5/35 28 Day PackPSN140c50d6-c931-423a-9aa0-526eae7ab93c16
751871Nortrel 1/35 21 Day PackPSN140c50d6-c931-423a-9aa0-526eae7ab93c16
751870Nortrel 1/35 28 Day PackPSN140c50d6-c931-423a-9aa0-526eae7ab93c16
310463ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral TabletSCD140c50d6-c931-423a-9aa0-526eae7ab93c16
312033ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral TabletSCD140c50d6-c931-423a-9aa0-526eae7ab93c16
748797inert ingredients 1 MG Oral TabletSCD140c50d6-c931-423a-9aa0-526eae7ab93c16
310463ethinyl estradiol 35 MCG / norethindrone 0.5 MG Oral TabletSY140c50d6-c931-423a-9aa0-526eae7ab93c16
312033ethinyl estradiol 35 MCG / norethindrone 1 MG Oral TabletSY140c50d6-c931-423a-9aa0-526eae7ab93c16
751868Nortrel 0.5/35 28 Day PackSY140c50d6-c931-423a-9aa0-526eae7ab93c16
751871Nortrel 1/35 21 Day PackSY140c50d6-c931-423a-9aa0-526eae7ab93c16
751870Nortrel 1/35 28 Day PackSY140c50d6-c931-423a-9aa0-526eae7ab93c16
751868{21 (ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Nortrel 0.5/35 28 Day]BPCK33b895e4-b467-41b1-a812-8068cc5bb93e11
749879{21 (ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK33b895e4-b467-41b1-a812-8068cc5bb93e11
749879Eth estra-Noreth 0.035-0.5 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN33b895e4-b467-41b1-a812-8068cc5bb93e11
748797inert 1 MG Oral TabletPSN33b895e4-b467-41b1-a812-8068cc5bb93e11
310463norethindrone 0.5 MG / ethinyl estradiol 0.035 MG Oral TabletPSN33b895e4-b467-41b1-a812-8068cc5bb93e11
751868Nortrel 0.5/35 28 Day PackPSN33b895e4-b467-41b1-a812-8068cc5bb93e11
310463ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral TabletSCD33b895e4-b467-41b1-a812-8068cc5bb93e11
748797inert ingredients 1 MG Oral TabletSCD33b895e4-b467-41b1-a812-8068cc5bb93e11
310463ethinyl estradiol 35 MCG / norethindrone 0.5 MG Oral TabletSY33b895e4-b467-41b1-a812-8068cc5bb93e11
751868Nortrel 0.5/35 28 Day PackSY33b895e4-b467-41b1-a812-8068cc5bb93e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0555-9008-67005559008673 POUCH in 1 CARTON (0555-9008-67) / 1 BLISTER PACK in 1 POUCH (0555-9008-79) / 1 KIT in 1 BLISTER PACK3 pouch2001-06-060000-00-00NoNoCurrent
0555-9008-79005559008791 in 1 POUCHHistorical