FDA.reportPublic FDA data

Doxycycline

Product NDC
0143-9381
11-digit product format
001439381
Labeler code
0143
Product ID
0143-9381_fa074f92-7cf9-4290-8cf7-7a2b94447cf3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA062992
Marketing category
ANDA
Marketing start
2021-05-17
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

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A062992-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP1989-02-16
A062992-002DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 200MG BASE/VIALINJECTABLE / INJECTIONAP1989-02-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A062992-001AP
A062992-002AP

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
2026-08-01 22:54:322026-06A062992-001DOXYCYCLINE HYCLATEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP1989-02-16a50c72e98297…
2026-08-01 22:54:322026-06A062992-002DOXYCYCLINE HYCLATEEQ 200MG BASE/VIALINJECTABLE / INJECTIONAP1989-02-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A062992-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A062992-002AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxycyclineDOXYCYCLINEHikma Pharmaceuticals USA Inc.2aa835bd-6fac-46b8-9716-9622fb550c8f2025-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062992
application number: ANDA062992
ndc (product): 0143-9381

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 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
2aa835bd-6fac-46b8-9716-9622fb550c8fAvailable 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9381-01Doxycycline1 in 1 VIALINJECTION, POWDER, FOR SOLUTION14
0143-9381-10Doxycycline10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9381-01EA - Each0143-9381e70a4d78-ed04-4286-9455-d7f00a9137a312021-06-02
0143-9381-10EA - Each0143-9381faff4297-0671-46f9-b8f2-38fdbc5d24a812021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9381DOXYCYCLINE INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]4Current NDC, Legacy NDC, 2 package rows20250502_2aa835bd-6fac-46b8-9716-9622fb550c8f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310027doxycycline hyclate 100 MG InjectionPSN2aa835bd-6fac-46b8-9716-9622fb550c8f4
310027doxycycline hyclate 100 MG InjectionSCD2aa835bd-6fac-46b8-9716-9622fb550c8f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9381-01001439381011 in 1 VIALHistorical
0143-9381-100014393811010 VIAL in 1 CARTON (0143-9381-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9381-01) 10 vial2021-05-170000-00-00NoNoCurrent