FDA.reportPublic FDA data

doxycycline hyclate

Product NDC
0378-0148
11-digit product format
003780148
Labeler code
0378
Product ID
0378-0148_23d6574e-a510-4187-84f7-194cd39f7e9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc
Application
ANDA062337
Marketing category
ANDA
Marketing start
1982-03-29
Marketing end
0000-00-00
Substance
DOXYCYCLINE HYC
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-cl
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0378-0148DDiscontinued by firm2026-08-03
excluded packagepackage0378-01480378-0148-05DDiscontinued by firm2026-08-03
excluded packagepackage0378-01480378-0148-89DDiscontinued 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A062337-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-03-29
A062337-002DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1982-03-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062337-001AB
A062337-002AB

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 22:54:322026-06A062337-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-03-29a50c72e98297…
2026-08-01 22:54:322026-06A062337-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1982-03-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A062337-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A062337-002AB1a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0148-05EA - Each0378-0148e9be6a4f-6a8a-46dc-bea5-d9ffd25abf4912014-08-01
0378-0148-89EA - Each0378-0148cdc6879b-6413-4233-824f-2e4c7ac09e6712014-08-01