FDA.reportPublic FDA data

Doxycycline

Product NDC
71335-3064
11-digit product format
713353064
Labeler code
71335
Product ID
71335-3064_6abca45c-7c23-4c1b-994e-f36b42e98a0c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA065055
Marketing category
ANDA
Marketing start
2022-08-01
Substance
DOXYCYCLINE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Doxycycline
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN12000U13O
Rxcui1649990

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
71335-3064-0Doxycycline2 in 1 BOTTLECAPSULE21
71335-3064-1Doxycycline30 in 1 BOTTLECAPSULE301
71335-3064-2Doxycycline14 in 1 BOTTLECAPSULE141
71335-3064-3Doxycycline20 in 1 BOTTLECAPSULE201
71335-3064-4Doxycycline12 in 1 BOTTLECAPSULE121
71335-3064-5Doxycycline40 in 1 BOTTLECAPSULE401
71335-3064-6Doxycycline10 in 1 BOTTLECAPSULE101
71335-3064-7Doxycycline50 in 1 BOTTLECAPSULE501
71335-3064-8Doxycycline21 in 1 BOTTLECAPSULE211
71335-3064-9Doxycycline60 in 1 BOTTLECAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-3064-0EA - Each71335-306420e89d97-3f3e-4399-91d7-99ad6edde43b12026-03-17
71335-3064-1EA - Each71335-3064bb6c567b-0b29-437b-9f4e-1328faabe3a012026-03-17
71335-3064-2EA - Each71335-3064ce240c4e-694c-4895-a27b-f49ad0acfd3712026-03-17
71335-3064-3EA - Each71335-3064ed56a29b-b447-4990-a8ee-9ee08340e17c12026-03-17
71335-3064-4EA - Each71335-30641899e9e5-1fed-4af4-994e-6317772a16e812026-03-17
71335-3064-5EA - Each71335-3064e2e626cc-a5f4-4f3e-8036-e2940d1ba89612026-03-17
71335-3064-6EA - Each71335-30641200d070-899e-450d-bd14-8e712545785812026-03-17
71335-3064-7EA - Each71335-3064593c7b7c-b6d7-4907-84f5-e8fb2555786112026-03-17
71335-3064-8EA - Each71335-306411fa12ba-41a3-41f3-8a0f-b52beabe4bfd12026-03-17
71335-3064-9EA - Each71335-30644382d037-7259-423e-86e7-eafa836aa48a12026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649990doxycycline monohydrate 100 MG Oral CapsulePSN6285181d-e34d-4def-abe6-2c41254ada751
1649990doxycycline monohydrate 100 MG Oral CapsuleSCD6285181d-e34d-4def-abe6-2c41254ada751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3064-0713353064002 CAPSULE in 1 BOTTLE (71335-3064-0) 2 capsule2026-02-06NoNoHistorical
71335-3064-17133530640130 CAPSULE in 1 BOTTLE (71335-3064-1) 30 capsule2026-02-06NoNoHistorical
71335-3064-27133530640214 CAPSULE in 1 BOTTLE (71335-3064-2) 14 capsule2026-02-06NoNoHistorical
71335-3064-37133530640320 CAPSULE in 1 BOTTLE (71335-3064-3) 20 capsule2026-02-06NoNoHistorical
71335-3064-47133530640412 CAPSULE in 1 BOTTLE (71335-3064-4) 12 capsule2026-02-06NoNoHistorical
71335-3064-57133530640540 CAPSULE in 1 BOTTLE (71335-3064-5) 40 capsule2026-02-06NoNoHistorical
71335-3064-67133530640610 CAPSULE in 1 BOTTLE (71335-3064-6) 10 capsule2026-02-06NoNoHistorical
71335-3064-77133530640750 CAPSULE in 1 BOTTLE (71335-3064-7) 50 capsule2026-02-06NoNoHistorical
71335-3064-87133530640821 CAPSULE in 1 BOTTLE (71335-3064-8) 21 capsule2026-02-06NoNoHistorical
71335-3064-97133530640960 CAPSULE in 1 BOTTLE (71335-3064-9) 60 capsule2026-02-06NoNoHistorical