FDA.reportPublic FDA data

Doxycycline

Product NDC
0378-6022
11-digit product format
003786022
Labeler code
0378
Product ID
0378-6022_5459d333-a2a5-460b-adc4-0099e50babce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc
Application
ANDA065377
Marketing category
ANDA
Marketing start
2006-11-17
Marketing end
2019-03-31
Substance
DOXYCYCLINE
Active strength
75 mg/1
Pharmacologic classes
Tetracycline-cl
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0378-6022DDiscontinued by firm2026-08-03
excluded packagepackage0378-60220378-6022-01DDiscontinued by firm2026-08-03

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065377-001DOXYCYCLINEDOXYCYCLINEEQ 50MG BASETABLET / ORAL2006-11-07
A065377-002DOXYCYCLINEDOXYCYCLINEEQ 75MG BASETABLET / ORAL2006-11-07
A065377-003DOXYCYCLINEDOXYCYCLINEEQ 100MG BASETABLET / ORAL2006-11-07

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 22:54:322026-06A065377-001DOXYCYCLINEEQ 50MG BASETABLET / ORAL2006-11-07a50c72e98297…
2026-08-01 22:54:322026-06A065377-002DOXYCYCLINEEQ 75MG BASETABLET / ORAL2006-11-07a50c72e98297…
2026-08-01 22:54:322026-06A065377-003DOXYCYCLINEEQ 100MG BASETABLET / ORAL2006-11-07a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-6022-01EA - Each0378-6022bba48734-ca2f-4eaf-8768-bfa54d28e1db12012-07-24