Doxycycline Hyclate

Product NDC
70934-046
11-digit product format
709340046
Labeler code
70934
Product ID
70934-046_a12a6e17-b577-1802-e053-2a95a90a793b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXYCYCLINE HYCLATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA062500
Marketing category
ANDA
Marketing start
2017-11-21
Marketing end
0000-00-00
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b4321c75-2e87-4d90-9726-9a28fb2293a3Product name320260112
5e99724e-0654-4aec-b7a2-0b9b10e312eeProduct name320250227
d2d36660-68ce-7e7d-0630-ec4b0d859fadProduct name620220921
a239f4dd-cf93-4660-b190-f97d000f249fProduct name720210607
a9d03566-caeb-4466-8021-74599b048880Product name320210604
12750814-20f7-4f35-b5fa-dbc8811ba858Product name920201007
00a5dbaa-1b7d-4e56-be0c-fedc7bbf5adeProduct name120200706
7b4b06ac-8c50-45f0-9556-293ea558a294Product name120180808
6a5b4392-5ab0-af0d-e0be-47b34e9dbb84Product name520171121
01a4aa74-7e05-63bd-bc10-1b5ceb111371Product name220171115
58b1278c-6dce-49b6-a05e-ea16f389acbaProduct name120160620

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-046-10Doxycycline Hyclate10 in 1 BOTTLE, PLASTICCAPSULE104
70934-046-14Doxycycline Hyclate14 in 1 BOTTLE, PLASTICCAPSULE144
70934-046-20Doxycycline Hyclate20 in 1 BOTTLECAPSULE204
70934-046-28Doxycycline Hyclate28 in 1 BOTTLE, PLASTICCAPSULE284

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-046-20EA - Each70934-046a81b0e65-7caa-4cc0-8835-21922a91683b12018-01-12
70934-046-28EA - Each70934-046defa5405-bffd-463e-90ff-53f3f8a36ccb12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-046DOXYCYCLINE HYCLATE CAPSULE [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]4Legacy NDC, 4 package rows20200319_5f899351-1c5d-62d7-e053-2991aa0ae2cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN5f899351-1c5d-62d7-e053-2991aa0ae2cb4
1649988doxycycline hyclate 100 MG Oral CapsuleSCD5f899351-1c5d-62d7-e053-2991aa0ae2cb4
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY5f899351-1c5d-62d7-e053-2991aa0ae2cb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-046-107093400461010 CAPSULE in 1 BOTTLE, PLASTIC (70934-046-10) 10 capsule2020-02-180000-00-00NoNoCurrent
70934-046-147093400461414 CAPSULE in 1 BOTTLE, PLASTIC (70934-046-14) 14 capsule2019-03-210000-00-00NoNoCurrent
70934-046-207093400462020 CAPSULE in 1 BOTTLE (70934-046-20) 20 capsule2017-11-210000-00-00NoNoCurrent
70934-046-287093400462828 CAPSULE in 1 BOTTLE, PLASTIC (70934-046-28) 28 capsule2018-01-080000-00-00NoNoCurrent