FDA.reportPublic FDA data

NDC 70700-316-84 - Orquidea

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
70700-316
Requested NDC
70700-316-84
Package NDCs from labels
70700-316-84, 70700-316-85
Manufacturer
Xiromed, LLC | Xiromed LLC
Effective date
2025-01-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Orquidea - Xiromed, LLC | Xiromed LLCXiromed, LLC | Xiromed LLC2025-01-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70700-316-84Orquidea1 in 1 POUCHTABLET11
70700-316-84Orquidea28 in 1 BLISTER PACKTABLET281
70700-316-85Orquidea3 in 1 CARTONTABLET31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70700-316ORQUIDEA (NORETHINDRONE) TABLET [XIROMED, LLC]1Current NDC, 3 package rows20250207_6e9f61a1-93ff-291a-bea8-9307a3b0378e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70700-316-84EA - Each70700-316a4eb0fa6-e0b1-416b-91d0-4905251b3c3512025-08-11
70700-316-85EA - Each70700-316a3e541ba-ea49-4e3a-801a-0e6771429b6d12025-08-11

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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
NorethindroneNORETHINDRONEGlenmark Pharmaceuticals Inc., USA0d2f8fea-3675-40d2-afd9-9fcb148dbd4b2026-01-31Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
unii: T18F433X4S
HEATHERNORETHINDRONEGlenmark Pharmaceuticals Inc., USA35b5ddb5-1729-4588-b2a2-ead56d78b6f92026-01-23Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
unii: T18F433X4S
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
NORETHINDRONENORETHINDRONEProficient Rx LPbbd54f1e-2d48-4efa-a57e-7fa7b478c4572026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
unii: T18F433X4S
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
JencyclaNORETHINDRONELupin Pharmaceuticals, Inc.e91e7bdd-2984-4332-9b0b-04322792d7f62025-12-08Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
unii: T18F433X4S
DEBLITANENORETHINDRONENorthstar Rx LLCe75367ff-78af-4bd2-a99d-d291cb1d21eb2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
SHAROBELNORETHINDRONENorthstar Rx LLCa96f5194-ad2a-4783-a9a9-22a288caff252025-12-05Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
MELEYANORETHINDRONEXiromed LLC534c5717-382c-4109-3208-e21b32e4c4c92025-03-06Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
unii: T18F433X4S
NORETHINDRONENORETHINDRONELupin Pharmaceuticals, Inc.121fbf86-1d76-4579-be2f-be9a957b23ab2025-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
unii: T18F433X4S
NORETHINDRONENORETHINDRONEA-S Medication Solutions70231aa1-9dd2-420f-9cb3-432d3c2477d12025-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
unii: T18F433X4S
OrquideaNORETHINDRONEXiromed, LLC6e9f61a1-93ff-291a-bea8-9307a3b0378e2025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201483
ndc (package): 70700-316-85
ndc (package): 70700-316-84
ndc (product): 70700-316
ndc11 (package): 70700031684
rxcui: 2704560
rxcui: 748961
rxcui: 198042
spl id: a54bf859-7035-5948-0a50-9c42bb791c9f
spl set id: 6e9f61a1-93ff-291a-bea8-9307a3b0378e
unii: T18F433X4S
AffodelNORETHINDRONENaari Pte. Limited8ec64ec8-fbc9-440d-9838-654a605d57da2024-04-22Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
unii: T18F433X4S
CAMILANORETHINDRONEDr. Reddy's Labratories Inc.59985565-af09-21ba-0336-3f6db7711bd12024-04-01Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
unii: T18F433X4S
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
ERRINNORETHINDRONEDr. Reddy's Labratories Inc.df29577b-c2f0-bea8-b048-7719972707aa2024-03-01Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
unii: T18F433X4S
ERRINNORETHINDRONEProficient Rx LP904899f2-9c54-44d2-901e-47e8945715002024-01-01Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
unii: T18F433X4S
EmzahhNORETHINDRONEAurobindo Pharma Limited197d31d3-eec8-49c7-9640-918ff138fea22023-04-10Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
unii: T18F433X4S

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.