FDA.reportPublic FDA data

Estradiol / Norethindrone Acetate

Product NDC
51991-474
11-digit product format
519910474
Labeler code
51991
Product ID
51991-474_d0f8f0e6-e2b1-40ff-8b4b-0ed8a7525689
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Estradiol and Norethindrone Acetate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Breckenridge Pharmaceutical, Inc.
Application
ANDA078324
Marketing category
ANDA
Marketing start
2008-04-17
Substance
ESTRADIOL; NORETHINDRONE ACETATE
Active strength
1; .5 mg/1; mg/1
Pharmacologic classes
Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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
A078324-001ESTRADIOL AND NORETHINDRONE ACETATEESTRADIOL; NORETHINDRONE ACETATE1MG;0.5MGTABLET / ORALAB2008-04-17
A078324-002ESTRADIOL AND NORETHINDRONE ACETATEESTRADIOL; NORETHINDRONE ACETATE0.5MG;0.1MGTABLET / ORALAB2011-06-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078324-001AB
A078324-002AB

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 UTC2026-02A078324-001ESTRADIOL AND NORETHINDRONE ACETATE1MG;0.5MGTABLET / ORALAB2008-04-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078324-002ESTRADIOL AND NORETHINDRONE ACETATE0.5MG;0.1MGTABLET / ORALAB2011-06-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078324-001ESTRADIOL AND NORETHINDRONE ACETATE1MG;0.5MGTABLET / ORALAB2008-04-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078324-002ESTRADIOL AND NORETHINDRONE ACETATE0.5MG;0.1MGTABLET / ORALAB2011-06-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A078324-001ESTRADIOL AND NORETHINDRONE ACETATE1MG;0.5MGTABLET / ORALAB2008-04-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078324-002ESTRADIOL AND NORETHINDRONE ACETATE0.5MG;0.1MGTABLET / ORALAB2011-06-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078324-001ESTRADIOL AND NORETHINDRONE ACETATE1MG;0.5MGTABLET / ORALAB2008-04-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078324-002ESTRADIOL AND NORETHINDRONE ACETATE0.5MG;0.1MGTABLET / ORALAB2011-06-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078324-001ESTRADIOL AND NORETHINDRONE ACETATE1MG;0.5MGTABLET / ORALAB2008-04-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078324-002ESTRADIOL AND NORETHINDRONE ACETATE0.5MG;0.1MGTABLET / ORALAB2011-06-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078324-001ESTRADIOL AND NORETHINDRONE ACETATE1MG;0.5MGTABLET / ORALAB2008-04-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078324-002ESTRADIOL AND NORETHINDRONE ACETATE0.5MG;0.1MGTABLET / ORALAB2011-06-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078324-001ESTRADIOL AND NORETHINDRONE ACETATE1MG;0.5MGTABLET / ORALAB2008-04-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078324-002ESTRADIOL AND NORETHINDRONE ACETATE0.5MG;0.1MGTABLET / ORALAB2011-06-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078324-001ESTRADIOL AND NORETHINDRONE ACETATE1MG;0.5MGTABLET / ORALAB2008-04-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078324-002ESTRADIOL AND NORETHINDRONE ACETATE0.5MG;0.1MGTABLET / ORALAB2011-06-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078324-001ESTRADIOL AND NORETHINDRONE ACETATE1MG;0.5MGTABLET / ORALAB2008-04-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078324-002ESTRADIOL AND NORETHINDRONE ACETATE0.5MG;0.1MGTABLET / ORALAB2011-06-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078324-001ESTRADIOL AND NORETHINDRONE ACETATE1MG;0.5MGTABLET / ORALAB2008-04-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A078324-002ESTRADIOL AND NORETHINDRONE ACETATE0.5MG;0.1MGTABLET / ORALAB2011-06-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078324-001ESTRADIOL AND NORETHINDRONE ACETATE1MG;0.5MGTABLET / ORALAB2008-04-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078324-002ESTRADIOL AND NORETHINDRONE ACETATE0.5MG;0.1MGTABLET / ORALAB2011-06-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078324-001ESTRADIOL AND NORETHINDRONE ACETATE1MG;0.5MGTABLET / ORALAB2008-04-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078324-002ESTRADIOL AND NORETHINDRONE ACETATE0.5MG;0.1MGTABLET / ORALAB2011-06-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078324-001ESTRADIOL AND NORETHINDRONE ACETATE1MG;0.5MGTABLET / ORALAB2008-04-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078324-002ESTRADIOL AND NORETHINDRONE ACETATE0.5MG;0.1MGTABLET / ORALAB2011-06-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078324-001ESTRADIOL AND NORETHINDRONE ACETATE1MG;0.5MGTABLET / ORALAB2008-04-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078324-002ESTRADIOL AND NORETHINDRONE ACETATE0.5MG;0.1MGTABLET / ORALAB2011-06-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078324-001ESTRADIOL AND NORETHINDRONE ACETATE1MG;0.5MGTABLET / ORALAB2008-04-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078324-002ESTRADIOL AND NORETHINDRONE ACETATE0.5MG;0.1MGTABLET / ORALAB2011-06-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078324-001ESTRADIOL AND NORETHINDRONE ACETATE1MG;0.5MGTABLET / ORALAB2008-04-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078324-002ESTRADIOL AND NORETHINDRONE ACETATE0.5MG;0.1MGTABLET / ORALAB2011-06-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078324-001ESTRADIOL AND NORETHINDRONE ACETATE1MG;0.5MGTABLET / ORALAB2008-04-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078324-002ESTRADIOL AND NORETHINDRONE ACETATE0.5MG;0.1MGTABLET / ORALAB2011-06-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078324-001ESTRADIOL AND NORETHINDRONE ACETATE1MG;0.5MGTABLET / ORALAB2008-04-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078324-002ESTRADIOL AND NORETHINDRONE ACETATE0.5MG;0.1MGTABLET / ORALAB2011-06-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078324-001ESTRADIOL AND NORETHINDRONE ACETATE1MG;0.5MGTABLET / ORALAB2008-04-17bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078324-002ESTRADIOL AND NORETHINDRONE ACETATE0.5MG;0.1MGTABLET / ORALAB2011-06-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078324-001ESTRADIOL AND NORETHINDRONE ACETATE1MG;0.5MGTABLET / ORALAB2008-04-17782e0a99824c…
2021-12-28 21:50 UTC2021-12A078324-002ESTRADIOL AND NORETHINDRONE ACETATE0.5MG;0.1MGTABLET / ORALAB2011-06-09782e0a99824c…

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 UTC2026-02A078324-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078324-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078324-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078324-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078324-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078324-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078324-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078324-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078324-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078324-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078324-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078324-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078324-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078324-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078324-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078324-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078324-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078324-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078324-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078324-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078324-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078324-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078324-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078324-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078324-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078324-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078324-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078324-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078324-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078324-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078324-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078324-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078324-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078324-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078324-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078324-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078324-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078324-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078324-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A078324-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Estradiol / Norethindrone Acetate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESTRADIOL1 mg/1
NORETHINDRONE ACETATE.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4TI98Z838EInternal UNII lookup
9S44LIC7OJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1359123Internal RxNorm lookup
1359124Internal RxNorm lookup
1359126Internal RxNorm lookup
1359127Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
44125b2f-10ac-435c-bdb4-a29bf8450dbfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5bec24fd-caeb-8b32-1ff0-ca0dd1751379Product name220250618
3fcaf367-cbc2-4d1e-845e-e1ce4b0d86a6Product name220250616
4ca088c7-0c0e-114d-ffaa-d1b94f9eadc1Product name620250311
d39a542a-f5b0-4c2d-a820-0f5d39e6621fProduct name120250307
99d68ea7-fba4-0d7b-b5fa-468e21dd1cbfProduct name220250204
a1c50ef5-9c2c-d846-1ca1-70fabf2428e1Product name320240507
66263a7f-f64d-41c4-90f1-2cee106617ccProduct name120240501
859c4b0b-8cba-4f41-9afe-cc181a01fb62Product name220240215
0d9f32e2-f85b-4d63-9f04-b06059c34749Product name320230323
76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
132e7bcf-ca42-94e4-3c78-c44ae7819a94Product name320220126
0a040ba8-1f34-4328-bb07-4f64503daaabProduct name220210513
833edb59-a012-45c2-aff5-2ed74b66fa59Product name120201207
cec4644c-0fed-4608-a5ea-d3a1b1b6d697Product name220200728
00a01e22-7ea3-6f8f-0cc1-380aac10f424Product name620200716
f4d31098-441e-52d3-27f1-49c829f8a3a1Product name520190703
001f367b-fa14-49a0-865b-b395f2553601Product name220190611
c21bcd2e-ecbd-48e6-ab68-12cc12256c0fProduct name220190213
c6636356-4ccb-40e9-a952-59eb1f2fc859Product name420180806
3f090665-4687-4bb4-8790-8efb1930ee74Product name120180801
e042bc86-5d40-8945-82f8-de9dd95420ddProduct name620180606
390e6d23-3a11-4327-9294-c958a378baaeProduct name420180124
b651f154-0364-4007-9dc6-9d33036db1d7Product name420170808
3395ac9b-f30b-4991-80ba-fd5196be0214Product name320170802
a5e2d962-d98c-4fbf-8183-ffd42dd01e19Product name620170711
00606b81-6e33-4c38-9ca9-bd14bd74d84cProduct name420170501
f4ce24e8-8632-4fad-9984-b693f985f80fProduct name320170501
b17c5419-b38b-579f-10bc-8a4ce69fc044Product name520170316
f6ac5560-6d3b-d281-41d2-adc50d283c20Product name320170228
01996782-abcb-4e6d-bcaf-4a23e6a95c0cProduct name120160714
7a549f52-8b99-472c-8b1d-3a70c53c9bf4Product name120160623
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
3ca8d96e-517a-05ea-5690-f8e1d3726540Product name120140508
5f44c957-835a-ada0-662f-5b1071b7a68bProduct name120140508
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3Product name120140508
7d6c8f26-fe65-2465-c993-66dd6e1c1183Product name120140508
83cac4be-cfee-33c1-5b8e-bb83ae18bce4Product name120140508
c3f7be78-e6d7-47c9-c840-70c566e8d5c4Product name120140508
d6b36b6b-65d6-a810-0fa7-61ddf1a96352Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51991-474-28Estradiol / Norethindrone Acetate28 in 1 BLISTER PACKTABLET, FILM COATED2810
51991-474-28Estradiol / Norethindrone Acetate1 in 1 CARTONTABLET, FILM COATED110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-474-28EA - Each51991-474136b48a1-3ac1-4e0e-94bc-0c7bf753df2b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EstradiolACTIVE INGREDIENT4TI98Z838EESTRADIOL / NORETHINDRONE ACETATE (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]2
Norethindrone AcetateACTIVE INGREDIENT9S44LIC7OJESTRADIOL / NORETHINDRONE ACETATE (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]2
EstradiolACTIVE MOIETY4TI98Z838EESTRADIOL / NORETHINDRONE ACETATE (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]2
NorethindroneACTIVE MOIETYT18F433X4SESTRADIOL / NORETHINDRONE ACETATE (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]2
copovidone K25-31INACTIVE INGREDIENTD9C330MD8BESTRADIOL / NORETHINDRONE ACETATE (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WOESTRADIOL / NORETHINDRONE ACETATE (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XESTRADIOL / NORETHINDRONE ACETATE (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30ESTRADIOL / NORETHINDRONE ACETATE (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]2
starch, cornINACTIVE INGREDIENTO8232NY3SJESTRADIOL / NORETHINDRONE ACETATE (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]2
talcINACTIVE INGREDIENT7SEV7J4R1UESTRADIOL / NORETHINDRONE ACETATE (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]2
triacetinINACTIVE INGREDIENTXHX3C3X673ESTRADIOL / NORETHINDRONE ACETATE (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]2
EstradiolACTIVE INGREDIENT4TI98Z838EESTRADIOL / NORETHINDRONE ACETATE (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
Norethindrone AcetateACTIVE INGREDIENT9S44LIC7OJESTRADIOL / NORETHINDRONE ACETATE (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
EstradiolACTIVE MOIETY4TI98Z838EESTRADIOL / NORETHINDRONE ACETATE (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
NorethindroneACTIVE MOIETYT18F433X4SESTRADIOL / NORETHINDRONE ACETATE (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
copovidoneINACTIVE INGREDIENTD9C330MD8BESTRADIOL / NORETHINDRONE ACETATE (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOESTRADIOL / NORETHINDRONE ACETATE (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XESTRADIOL / NORETHINDRONE ACETATE (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ESTRADIOL / NORETHINDRONE ACETATE (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
starch, cornINACTIVE INGREDIENTO8232NY3SJESTRADIOL / NORETHINDRONE ACETATE (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
talcINACTIVE INGREDIENT7SEV7J4R1UESTRADIOL / NORETHINDRONE ACETATE (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
triacetinINACTIVE INGREDIENTXHX3C3X673ESTRADIOL / NORETHINDRONE ACETATE (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51991-474ESTRADIOL / NORETHINDRONE ACETATE (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]10Current NDC, Legacy NDC, 2 package rows20240327_44125b2f-10ac-435c-bdb4-a29bf8450dbf.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Estradiol / Norethindrone AcetateESTRADIOL AND NORETHINDRONE ACETATEA-S Medication Solutionse166bdf6-eb60-49b8-9747-2a33c3e3461b2026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078324
application number: ANDA078324
Estradiol / Norethindrone AcetateESTRADIOL AND NORETHINDRONE ACETATEBreckenridge Pharmaceutical, Inc.44125b2f-10ac-435c-bdb4-a29bf8450dbf2024-02-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078324
application number: ANDA078324
ndc (product): 51991-474

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1359124{28 (estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral Tablet) } PackGPCK44125b2f-10ac-435c-bdb4-a29bf8450dbf10
1359127{28 (estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet) } PackGPCK44125b2f-10ac-435c-bdb4-a29bf8450dbf10
1359124Estra-Noreth Ac 0.5-0.1 MG (28) Oral Tablet 28 Day PackPSN44125b2f-10ac-435c-bdb4-a29bf8450dbf10
1359127Estra-Noreth Ac 1-0.5 MG (28) Oral Tablet 28 Day PackPSN44125b2f-10ac-435c-bdb4-a29bf8450dbf10
1359123estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral TabletPSN44125b2f-10ac-435c-bdb4-a29bf8450dbf10
1359126estradiol 1 MG / norethindrone acetate 0.5 MG Oral TabletPSN44125b2f-10ac-435c-bdb4-a29bf8450dbf10
1359123estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral TabletSCD44125b2f-10ac-435c-bdb4-a29bf8450dbf10
1359126estradiol 1 MG / norethindrone acetate 0.5 MG Oral TabletSCD44125b2f-10ac-435c-bdb4-a29bf8450dbf10
1359127{28 (estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet) } PackGPCKb85df980-7df1-4973-bee3-ae51274b588f1
1359127Estra-Noreth Ac 1-0.5 MG (28) Oral Tablet 28 Day PackPSNb85df980-7df1-4973-bee3-ae51274b588f1
1359126estradiol 1 MG / norethindrone acetate 0.5 MG Oral TabletPSNb85df980-7df1-4973-bee3-ae51274b588f1
1359126estradiol 1 MG / norethindrone acetate 0.5 MG Oral TabletSCDb85df980-7df1-4973-bee3-ae51274b588f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51991-474-28519910474281 BLISTER PACK in 1 CARTON (51991-474-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2008-04-170000-00-00NoNoCurrent