FDA.reportPublic FDA data

doxycycline

Product NDC
62135-417
11-digit product format
621350417
Labeler code
62135
Product ID
62135-417_40077986-5ebb-f8f0-e063-6394a90ad09f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Chartwell RX LLC
Application
ANDA065454
Marketing category
ANDA
Marketing start
2008-07-16
Substance
DOXYCYCLINE
Active strength
25 mg/5mL
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
A065454-001DOXYCYCLINEDOXYCYCLINEEQ 25MG BASE/5MLFOR SUSPENSION / ORALAB2008-07-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065454-001AB

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 22:54:322026-06A065454-001DOXYCYCLINEEQ 25MG BASE/5MLFOR SUSPENSION / ORALAB2008-07-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A065454-001AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
doxycyclineDOXYCYCLINEChartwell Governmental & Specialty RX, LLCb8486639-7eb9-4610-9cd4-0e922045d5922025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065454
application number: ANDA065454
doxycyclineDOXYCYCLINEChartwell RX LLC3e7cf78f-3b48-4614-9fa4-c6d1e0c05a352025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065454
application number: ANDA065454
ndc (product): 62135-417

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE25 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
19XTS3T51UInternal UNII lookup
N12000U13OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1649405Internal RxNorm lookup
1649988Internal RxNorm lookup
1650030Internal RxNorm lookup
1650143Internal RxNorm lookup
1652674Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3e7cf78f-3b48-4614-9fa4-c6d1e0c05a35Available 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
62135-417-46doxycycline60 mL in 1 BOTTLE, GLASSPOWDER, FOR SUSPENSION6016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-417-46ML - Milliliter62135-417caef6e13-7571-4564-8c42-3686dfb068bd12020-04-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Doxycycline HyclateACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]3
Doxycycline AnhydrousACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]3
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKDOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]3
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]3
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOADOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]3
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]3
hypromellosesINACTIVE INGREDIENT3NXW29V3WODOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]3
magnesium stearateINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]3
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ADOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]3
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]3
stearic acidINACTIVE INGREDIENT4ELV7Z65APDOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]3
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-417DOXYCYCLINE HYCLATE TABLET, FILM COATED DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE POWDER, FOR SUSPENSION [CHARTWELL RX LLC]15Current NDC, Legacy NDC, 1 package rows20240402_3e7cf78f-3b48-4614-9fa4-c6d1e0c05a35.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN3e7cf78f-3b48-4614-9fa4-c6d1e0c05a3516
1650143doxycycline hyclate 100 MG Oral TabletPSN3e7cf78f-3b48-4614-9fa4-c6d1e0c05a3516
1649405doxycycline hyclate 50 MG Oral CapsulePSN3e7cf78f-3b48-4614-9fa4-c6d1e0c05a3516
1652674doxycycline hyclate 50 MG Oral TabletPSN3e7cf78f-3b48-4614-9fa4-c6d1e0c05a3516
1650030doxycycline monohydrate 25 MG in 5 mL Oral SuspensionPSN3e7cf78f-3b48-4614-9fa4-c6d1e0c05a3516
1649988doxycycline hyclate 100 MG Oral CapsuleSCD3e7cf78f-3b48-4614-9fa4-c6d1e0c05a3516
1650143doxycycline hyclate 100 MG Oral TabletSCD3e7cf78f-3b48-4614-9fa4-c6d1e0c05a3516
1649405doxycycline hyclate 50 MG Oral CapsuleSCD3e7cf78f-3b48-4614-9fa4-c6d1e0c05a3516
1652674doxycycline hyclate 50 MG Oral TabletSCD3e7cf78f-3b48-4614-9fa4-c6d1e0c05a3516
1650030doxycycline monohydrate 5 MG/ML Oral SuspensionSCD3e7cf78f-3b48-4614-9fa4-c6d1e0c05a3516
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY3e7cf78f-3b48-4614-9fa4-c6d1e0c05a3516
1650030doxycycline monohydrate 25 MG per 5 ML Oral SuspensionSY3e7cf78f-3b48-4614-9fa4-c6d1e0c05a3516

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-417-466213504174660 mL in 1 BOTTLE, GLASS (62135-417-46) 60 ml2018-01-010000-00-00NoNoCurrent