FDA.reportPublic FDA data

MELEYA

Product NDC
70700-317
11-digit product format
707000317
Labeler code
70700
Product ID
70700-317_a3bb0699-e518-4526-e81e-df5e1afefe38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norethindrone
Dosage form
TABLET
Route
ORAL
Labeler
Xiromed LLC
Application
ANDA200980
Marketing category
ANDA
Marketing start
2025-01-29
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
MELEYA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NORETHINDRONE.35 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT18F433X4S
Rxcui198042, 748961, 2716571

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d39a542a-f5b0-4c2d-a820-0f5d39e6621fProduct name120250307
859c4b0b-8cba-4f41-9afe-cc181a01fb62Product name220240215
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
70700-317-84MELEYA1 in 1 POUCHTABLET12
70700-317-84MELEYA28 in 1 BLISTER PACKTABLET282
70700-317-85MELEYA3 in 1 CARTONTABLET32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70700-317-84EA - Each70700-3171dd516fa-81a0-4b3a-a8bd-e58bd613b3ae12025-07-08
70700-317-85EA - Each70700-3176c384389-d1e6-4f7b-a9ed-afb74c58676612025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70700-317MELEYA (NORETHINDRONE) TABLET [XIROMED LLC]2Current NDC, 3 package rows20250418_534c5717-382c-4109-3208-e21b32e4c4c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2716571{28 (norethindrone 0.35 MG Oral Tablet) } Pack [Meleya 28 Day]BPCK534c5717-382c-4109-3208-e21b32e4c4c92
748961{28 (norethindrone 0.35 MG Oral Tablet) } PackGPCK534c5717-382c-4109-3208-e21b32e4c4c92
2716571Meleya 28 Day PackPSN534c5717-382c-4109-3208-e21b32e4c4c92
748961Noreth 0.35 MG (28) Oral Tablet 28 Day PackPSN534c5717-382c-4109-3208-e21b32e4c4c92
198042norethindrone 0.35 MG Oral TabletPSN534c5717-382c-4109-3208-e21b32e4c4c92
198042norethindrone 0.35 MG Oral TabletSCD534c5717-382c-4109-3208-e21b32e4c4c92
2716571Meleya 28 Day PackSY534c5717-382c-4109-3208-e21b32e4c4c92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70700-317-84707000317841 in 1 POUCHHistorical
70700-317-85707000317853 POUCH in 1 CARTON (70700-317-85) / 1 BLISTER PACK in 1 POUCH (70700-317-84) / 28 TABLET in 1 BLISTER PACK3 pouch2025-01-29NoNoHistorical