FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
70934-085
11-digit product format
709340085
Labeler code
70934
Product ID
70934-085_b8b7df02-596b-0766-e053-2a95a90ae1ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA207289
Marketing category
ANDA
Marketing start
2018-03-05
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
2022-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70934-085-142023-01-30C16284748780-1ba0f9c33-48ae-a910-e053-dadaa90a0b85Doxycycline Hyclate Capsules, USP (100 mg) Rx Only
70934-085-202023-01-30C16284748780-1ba0f9c33-48ae-a910-e053-dadaa90a0b85Doxycycline Hyclate Capsules, USP (100 mg) Rx Only
70934-085-142021-01-31C16284748780-1ba0f9c33-48ae-a910-e053-dadaa90a0b85Doxycycline Hyclate Capsules, USP (100 mg) Rx Only
70934-085-202021-01-31C16284748780-1ba0f9c33-48ae-a910-e053-dadaa90a0b85Doxycycline Hyclate Capsules, USP (100 mg) Rx Only
70934-085-142021-01-29C16284748780-1ba0f9c33-48ae-a910-e053-dadaa90a0b85Doxycycline Hyclate Capsules, USP (100 mg) Rx Only
70934-085-202021-01-29C16284748780-1ba0f9c33-48ae-a910-e053-dadaa90a0b85Doxycycline Hyclate Capsules, USP (100 mg) Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-085-14Doxycycline Hyclate14 in 1 BOTTLE, PLASTICCAPSULE144
70934-085-20Doxycycline Hyclate20 in 1 BOTTLE, PLASTICCAPSULE204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-085-14EA - Each70934-08511b71f6a-1b47-4a08-89f7-4239d43ce1fe12018-09-05
70934-085-20EA - Each70934-085538fa249-9f14-4ca0-b874-81f1a7b4e0e512018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-085DOXYCYCLINE HYCLATE (DOXYCYCLINE) CAPSULE [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]4Legacy NDC, 2 package rows20210131_696f8eba-68c5-8f1c-e053-2991aa0a1124.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN696f8eba-68c5-8f1c-e053-2991aa0a11244
1649988doxycycline hyclate 100 MG Oral CapsuleSCD696f8eba-68c5-8f1c-e053-2991aa0a11244
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY696f8eba-68c5-8f1c-e053-2991aa0a11244

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-085-147093400851414 CAPSULE in 1 BOTTLE, PLASTIC (70934-085-14) 14 capsule2018-04-110000-00-00NoNoCurrent
70934-085-207093400852020 CAPSULE in 1 BOTTLE, PLASTIC (70934-085-20) 20 capsule2018-03-050000-00-00NoNoCurrent