FDA.reportPublic FDA data

DOXYCYCLINE

Product NDC
43598-086
11-digit product format
435980086
Labeler code
43598
Product ID
43598-086_d81118bc-54c2-51cd-4ddd-d3afcf12ddf8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXYCYCLINE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Dr. Reddy's Laboratories, Inc.
Application
ANDA218753
Marketing category
ANDA
Marketing start
2025-07-18
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/10mL
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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
A218753-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2025-07-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218753-001AP

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 UTC2026-02A218753-001DOXYCYCLINE HYCLATEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2025-07-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218753-001DOXYCYCLINE HYCLATEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2025-07-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218753-001DOXYCYCLINE HYCLATEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2025-07-016a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218753-001DOXYCYCLINE HYCLATEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2025-07-01a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218753-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218753-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218753-001AP16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218753-001AP1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE HYCLATE100 mg/10mL

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
c0206e91-d87f-311c-80dc-aad543d001e8Available 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
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
43598-086-58DOXYCYCLINE DOXYCYCLINE10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,105
43598-086-58DOXYCYCLINE DOXYCYCLINE10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-086-58EA - Each43598-086a0126a42-fd4d-4d9f-b924-b5bf0deaa2f412025-08-11

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
DOXYCYCLINE DOXYCYCLINEDOXYCYCLINEDr. Reddy's Laboratories, Inc.c0206e91-d87f-311c-80dc-aad543d001e82025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218753
application number: ANDA218753
ndc (product): 43598-086

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310027doxycycline hyclate 100 MG InjectionPSNc0206e91-d87f-311c-80dc-aad543d001e85
310027doxycycline hyclate 100 MG InjectionSCDc0206e91-d87f-311c-80dc-aad543d001e85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
43598-086-584359800865810 VIAL, SINGLE-DOSE in 1 CARTON (43598-086-58) / 10 mL in 1 VIAL, SINGLE-DOSE2025-07-18NoNoCurrent