FDA.reportPublic FDA data

Doxycycline

Product NDC
82449-008
11-digit product format
824490008
Labeler code
82449
Product ID
82449-008_43c652e3-b11e-251e-e063-6394a90a67a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Steriscience Specialties Private Limited
Application
ANDA217972
Marketing category
ANDA
Marketing start
2026-05-10
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/100mg
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217972-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2025-11-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A217972-001AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A217972-001DOXYCYCLINE HYCLATEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2025-11-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217972-001DOXYCYCLINE HYCLATEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2025-11-0631067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217972-001DOXYCYCLINE HYCLATEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2025-11-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A217972-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217972-001AP131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217972-001AP1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE HYCLATE100 mg/100mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
19XTS3T51UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310027Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6d1f7b0f-b71d-4cee-803b-fe418d000c9cAvailable on FDA.report

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
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
82449-008-02Doxycycline100 mg in 1 VIALINJECTION, POWDER, LYOPHILIZED,1001
82449-008-02Doxycycline10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,101

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxycyclineDOXYCYCLINESteriscience Specialties Private Limited6d1f7b0f-b71d-4cee-803b-fe418d000c9c2025-11-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217972
application number: ANDA217972
ndc (product): 82449-008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310027doxycycline hyclate 100 MG InjectionPSN6d1f7b0f-b71d-4cee-803b-fe418d000c9c1
310027doxycycline hyclate 100 MG InjectionSCD6d1f7b0f-b71d-4cee-803b-fe418d000c9c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82449-008-028244900080210 VIAL in 1 CARTON (82449-008-02) / 100 mg in 1 VIAL10 vial2026-05-10NoNoCurrent