FDA.reportPublic FDA data

doxycycline

Product NDC
71335-2100
11-digit product format
713352100
Labeler code
71335
Product ID
71335-2100_a08770d5-2788-4264-9790-cdddb6e59d61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209402
Marketing category
ANDA
Marketing start
2021-11-19
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
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
71335-2100-0doxycycline6 in 1 BOTTLECAPSULE6103
71335-2100-1doxycycline10 in 1 BOTTLECAPSULE10103
71335-2100-2doxycycline20 in 1 BOTTLECAPSULE20103
71335-2100-3doxycycline30 in 1 BOTTLECAPSULE30103
71335-2100-4doxycycline40 in 1 BOTTLECAPSULE40103
71335-2100-5doxycycline60 in 1 BOTTLECAPSULE60103
71335-2100-6doxycycline28 in 1 BOTTLECAPSULE28103
71335-2100-7doxycycline14 in 1 BOTTLECAPSULE14103
71335-2100-8doxycycline90 in 1 BOTTLECAPSULE90103
71335-2100-9doxycycline365 in 1 BOTTLECAPSULE365103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2100-1EA - Each71335-2100364046f3-bea3-4b76-84a9-ea07964102a212024-02-14
71335-2100-2EA - Each71335-21000da7f377-01dd-4451-b941-18731730cf4c12024-02-14
71335-2100-4EA - Each71335-2100c928b5e7-27b7-4b4c-aa2f-e430c14122f112024-02-14
71335-2100-5EA - Each71335-21006c489f61-1d21-4364-a93d-7e77e38e315a12024-02-14
71335-2100-6EA - Each71335-210078da27a9-9c50-47f4-85c4-6f648fe2bcf912024-02-14
71335-2100-7EA - Each71335-2100f819c1da-2cf7-4aa7-8a10-2df67bf50cad12024-02-14
71335-2100-8EA - Each71335-21001f290442-9469-4c31-8803-ca8a0e452e8812024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2100DOXYCYCLINE CAPSULE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 10 package rows20240823_1df9e905-d2e7-4a5a-8bd6-43f4850ba900.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN1df9e905-d2e7-4a5a-8bd6-43f4850ba900103
1649988doxycycline hyclate 100 MG Oral CapsuleSCD1df9e905-d2e7-4a5a-8bd6-43f4850ba900103
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY1df9e905-d2e7-4a5a-8bd6-43f4850ba900103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2100-0713352100006 CAPSULE in 1 BOTTLE (71335-2100-0) 6 capsule2022-06-060000-00-00NoNoCurrent
71335-2100-17133521000110 CAPSULE in 1 BOTTLE (71335-2100-1) 10 capsule2022-06-060000-00-00NoNoCurrent
71335-2100-27133521000220 CAPSULE in 1 BOTTLE (71335-2100-2) 20 capsule2022-06-060000-00-00NoNoCurrent
71335-2100-37133521000330 CAPSULE in 1 BOTTLE (71335-2100-3) 30 capsule2022-06-060000-00-00NoNoCurrent
71335-2100-47133521000440 CAPSULE in 1 BOTTLE (71335-2100-4) 40 capsule2022-06-060000-00-00NoNoCurrent
71335-2100-57133521000560 CAPSULE in 1 BOTTLE (71335-2100-5) 60 capsule2022-06-060000-00-00NoNoCurrent
71335-2100-67133521000628 CAPSULE in 1 BOTTLE (71335-2100-6) 28 capsule2022-06-060000-00-00NoNoCurrent
71335-2100-77133521000714 CAPSULE in 1 BOTTLE (71335-2100-7) 14 capsule2022-06-060000-00-00NoNoCurrent
71335-2100-87133521000890 CAPSULE in 1 BOTTLE (71335-2100-8) 90 capsule2022-06-060000-00-00NoNoCurrent
71335-2100-971335210009365 CAPSULE in 1 BOTTLE (71335-2100-9) 365 capsule2022-06-060000-00-00NoNoCurrent