Incassia

Product NDC
65862-925
11-digit product format
658620925
Labeler code
65862
Product ID
65862-925_0caa1c4e-9536-49b0-a523-b6a6676434ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NORETHINDRONE
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA207304
Marketing category
ANDA
Marketing start
2016-09-23
Substance
NORETHINDRONE
Active strength
.35 mg/1
Pharmacologic classes
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
Incassia
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NORETHINDRONE.35 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT18F433X4S
Rxcui198042, 748961, 2052064

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d39a542a-f5b0-4c2d-a820-0f5d39e6621fProduct name120250307
859c4b0b-8cba-4f41-9afe-cc181a01fb62Product name220240215
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
0d9f32e2-f85b-4d63-9f04-b06059c34749Product name320230323
833edb59-a012-45c2-aff5-2ed74b66fa59Product name120201207
cec4644c-0fed-4608-a5ea-d3a1b1b6d697Product name220200728
00a01e22-7ea3-6f8f-0cc1-380aac10f424Product name620200716
f4d31098-441e-52d3-27f1-49c829f8a3a1Product name520190703
c21bcd2e-ecbd-48e6-ab68-12cc12256c0fProduct name220190213
c6636356-4ccb-40e9-a952-59eb1f2fc859Product name420180806
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-925-28Incassia1 in 1 CARTONTABLET18
65862-925-28Incassia1 in 1 BLISTER PACKTABLET18
65862-925-85Incassia3 in 1 CARTONTABLET38
65862-925-85Incassia1 in 1 BLISTER PACKTABLET18
65862-925-86Incassia6 in 1 CARTONTABLET68
65862-925-86Incassia1 in 1 BLISTER PACKTABLET18
65862-925-87Incassia1 in 1 POUCHTABLET18
65862-925-87Incassia1 in 1 CARTONTABLET18
65862-925-88Incassia1 in 1 POUCHTABLET18
65862-925-88Incassia3 in 1 CARTONTABLET38
65862-925-92Incassia6 in 1 CARTONTABLET68
65862-925-92Incassia1 in 1 POUCHTABLET18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-925-28EA - Each65862-925ebdf751f-25ae-47fe-957c-fe6e73b27be712018-08-13
65862-925-85EA - Each65862-925247fa9fb-7f3d-481f-b244-123762a7c37012018-08-13
65862-925-87EA - Each65862-925a8002607-3196-4e79-a9c5-2d06063f4cba12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-925INCASSIA (NORETHINDRONE) TABLET [AUROBINDO PHARMA LIMITED]8Current NDC, Legacy NDC, 12 package rows20210918_0b87cef0-610c-469d-92ba-4007f4bc3878.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2052064{28 (norethindrone 0.35 MG Oral Tablet) } Pack [Incassia 28 Day]BPCK0b87cef0-610c-469d-92ba-4007f4bc38788
748961{28 (norethindrone 0.35 MG Oral Tablet) } PackGPCK0b87cef0-610c-469d-92ba-4007f4bc38788
2052064Incassia 28 DayPSN0b87cef0-610c-469d-92ba-4007f4bc38788
748961Noreth 0.35 MG (28) Oral Tablet 28 Day PackPSN0b87cef0-610c-469d-92ba-4007f4bc38788
198042norethindrone 0.35 MG Oral TabletPSN0b87cef0-610c-469d-92ba-4007f4bc38788
198042norethindrone 0.35 MG Oral TabletSCD0b87cef0-610c-469d-92ba-4007f4bc38788
2052064Incassia 28 DaySY0b87cef0-610c-469d-92ba-4007f4bc38788

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-925-28658620925281 BLISTER PACK in 1 CARTON (65862-925-28) / 1 TABLET in 1 BLISTER PACK1 blister pack2016-09-230000-00-00NoNoCurrent
65862-925-85658620925853 BLISTER PACK in 1 CARTON (65862-925-85) / 1 TABLET in 1 BLISTER PACK3 blister pack2016-09-230000-00-00NoNoCurrent
65862-925-86658620925866 BLISTER PACK in 1 CARTON (65862-925-86) / 1 TABLET in 1 BLISTER PACK6 blister pack2016-09-230000-00-00NoNoCurrent
65862-925-87658620925871 POUCH in 1 CARTON (65862-925-87) / 1 TABLET in 1 POUCH1 pouch2016-09-230000-00-00NoNoCurrent
65862-925-88658620925883 POUCH in 1 CARTON (65862-925-88) / 1 TABLET in 1 POUCH3 pouch2016-09-230000-00-00NoNoCurrent
65862-925-92658620925926 POUCH in 1 CARTON (65862-925-92) / 1 TABLET in 1 POUCH6 pouch2016-09-230000-00-00NoNoCurrent