FDA.reportPublic FDA data

ABIGALE

Product NDC
70700-330
11-digit product format
707000330
Labeler code
70700
Product ID
70700-330_35d8f763-8f98-f5ea-fae8-1367b638e82c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
estradiol and norethindrone acetate
Dosage form
TABLET
Route
ORAL
Labeler
Xiromed LLC
Application
ANDA207261
Marketing category
ANDA
Marketing start
2025-01-29
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

Additional Listing Data#

Finished product
Yes
Brand name base
ABIGALE
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4TI98Z838E, 9S44LIC7OJ
Rxcui1359123, 1359124, 1359126, 1359127, 2706646, 2706647

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
70700-330-84ABIGALE28 in 1 BLISTER PACKTABLET281
70700-330-84ABIGALE1 in 1 POUCHTABLET11
70700-330-85ABIGALE3 in 1 CARTONTABLET31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70700-330ABIGALE (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET ABIGALE LO (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET [XIROMED LLC]1Current NDC, 3 package rows20250306_df013d36-de10-0607-7e12-95ed43bf7ee9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2706647{28 (estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral Tablet) } Pack [Abigale Lo 0.5/0.1 28 Day]BPCKdf013d36-de10-0607-7e12-95ed43bf7ee91
2706646{28 (estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet) } Pack [Abigale 1/0.5 28 Day]BPCKdf013d36-de10-0607-7e12-95ed43bf7ee91
1359124{28 (estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral Tablet) } PackGPCKdf013d36-de10-0607-7e12-95ed43bf7ee91
1359127{28 (estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet) } PackGPCKdf013d36-de10-0607-7e12-95ed43bf7ee91
2706646Abigale 1/0.5 28 Day PackPSNdf013d36-de10-0607-7e12-95ed43bf7ee91
2706647Abigale Lo 0.5/0.1 28 Day PackPSNdf013d36-de10-0607-7e12-95ed43bf7ee91
1359124Estra-Noreth Ac 0.5-0.1 MG (28) Oral Tablet 28 Day PackPSNdf013d36-de10-0607-7e12-95ed43bf7ee91
1359127Estra-Noreth Ac 1-0.5 MG (28) Oral Tablet 28 Day PackPSNdf013d36-de10-0607-7e12-95ed43bf7ee91
1359123estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral TabletPSNdf013d36-de10-0607-7e12-95ed43bf7ee91
1359126estradiol 1 MG / norethindrone acetate 0.5 MG Oral TabletPSNdf013d36-de10-0607-7e12-95ed43bf7ee91
1359123estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral TabletSCDdf013d36-de10-0607-7e12-95ed43bf7ee91
1359126estradiol 1 MG / norethindrone acetate 0.5 MG Oral TabletSCDdf013d36-de10-0607-7e12-95ed43bf7ee91
2706646Abigale 1/0.5 28 Day PackSYdf013d36-de10-0607-7e12-95ed43bf7ee91
2706647Abigale Lo 0.5/0.1 28 Day PackSYdf013d36-de10-0607-7e12-95ed43bf7ee91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70700-330-847070003308428 in 1 BLISTER PACKHistorical
70700-330-85707000330853 POUCH in 1 CARTON (70700-330-85) / 1 BLISTER PACK in 1 POUCH (70700-330-84) / 28 TABLET in 1 BLISTER PACK3 pouch2025-01-29NoNoCurrent