FDA.reportPublic FDA data

doxycycline hyclate

Product NDC
71205-518
11-digit product format
712050518
Labeler code
71205
Product ID
71205-518_f8be598e-17df-45df-8c0b-13f2e61e4312
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA062500
Marketing category
ANDA
Marketing start
1984-09-11
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
doxycycline hyclate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE HYCLATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19XTS3T51U
Rxcui1649988

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-518-02doxycycline hyclate2 in 1 BOTTLECAPSULE22
71205-518-06doxycycline hyclate6 in 1 BOTTLECAPSULE62
71205-518-10doxycycline hyclate10 in 1 BOTTLECAPSULE102
71205-518-14doxycycline hyclate14 in 1 BOTTLECAPSULE142
71205-518-20doxycycline hyclate20 in 1 BOTTLECAPSULE202
71205-518-30doxycycline hyclate30 in 1 BOTTLECAPSULE302
71205-518-42doxycycline hyclate42 in 1 BOTTLECAPSULE422
71205-518-60doxycycline hyclate60 in 1 BOTTLECAPSULE602
71205-518-90doxycycline hyclate90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-518-14EA - Each71205-518754bfc18-2bbf-45eb-b5a9-64d16f02f84212024-05-16
71205-518-20EA - Each71205-518f12b423b-8304-4731-8de5-f60e9880d49312021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-518DOXYCYCLINE HYCLATE CAPSULE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 9 package rows20220426_2993ac3d-0ec4-4230-858e-9fd00063cf57.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN2993ac3d-0ec4-4230-858e-9fd00063cf572
1649988doxycycline hyclate 100 MG Oral CapsuleSCD2993ac3d-0ec4-4230-858e-9fd00063cf572
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY2993ac3d-0ec4-4230-858e-9fd00063cf572

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-518-02712050518022 CAPSULE in 1 BOTTLE (71205-518-02) 2 capsule2021-01-070000-00-00NoNoCurrent
71205-518-06712050518066 CAPSULE in 1 BOTTLE (71205-518-06) 6 capsule2021-01-070000-00-00NoNoCurrent
71205-518-107120505181010 CAPSULE in 1 BOTTLE (71205-518-10) 10 capsule2021-01-070000-00-00NoNoCurrent
71205-518-147120505181414 CAPSULE in 1 BOTTLE (71205-518-14) 14 capsule2021-01-070000-00-00NoNoCurrent
71205-518-207120505182020 CAPSULE in 1 BOTTLE (71205-518-20) 20 capsule2021-01-070000-00-00NoNoCurrent
71205-518-307120505183030 CAPSULE in 1 BOTTLE (71205-518-30) 30 capsule2021-01-070000-00-00NoNoCurrent
71205-518-427120505184242 CAPSULE in 1 BOTTLE (71205-518-42) 42 capsule2021-01-070000-00-00NoNoCurrent
71205-518-607120505186060 CAPSULE in 1 BOTTLE (71205-518-60) 60 capsule2021-01-070000-00-00NoNoCurrent
71205-518-907120505189090 CAPSULE in 1 BOTTLE (71205-518-90) 90 capsule2021-01-070000-00-00NoNoCurrent