doxycycline hyclate

Product NDC: 0378-0145
11-digit product format: 003780145
Labeler code: 0378
Product ID: 0378-0145_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: 50 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0378-0145		D	Discontinued by firm		2026-07-31
excluded package	package	0378-0145	0378-0145-89	D	Discontinued by firm		2026-07-31

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A062337-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1982-03-29
A062337-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1982-03-29

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A062337-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1982-03-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A062337-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1982-03-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A062337-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A062337-002	AB	1	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-0145-89	EA - Each	0378-0145	2228f203-9145-4a26-8f5b-dd779b6f9f6f	1	2014-08-01