MILLIPRED

Product NDC: 73534-505
11-digit product format: 735340505
Labeler code: 73534
Product ID: 73534-505_99178428-6ca6-466e-9596-4a422c9d4fe2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREDNISOLONE
Dosage form: TABLET
Route: ORAL
Labeler: Avalo Therapeutics Inc.
Application: ANDA080354
Marketing category: ANDA
Marketing start: 2022-03-31
Marketing end: 0000-00-00
Substance: PREDNISOLONE
Active strength: 5 mg/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	73534-505		D	Discontinued by firm		2026-07-31
excluded package	package	73534-505	73534-505-01	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A080354-001	PREDNISOLONE	PREDNISOLONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A080354-001	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	A080354-001	PREDNISOLONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`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	A080354-001	AB	1	`a50c72e98297…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
73534-505-01	2024-07-22	C162847	48780-1	1030e365-4422-111a-e063-dadaa90a10e2	MILLIPRED™ Tablet (prednisolone tablets USP) Rx only
73534-505-01	2024-01-30	C162847	48780-1	1030e365-4422-111a-e063-dadaa90a10e2	MILLIPRED™ Tablet (prednisolone tablets USP) Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
73534-505-01	EA - Each	73534-505	13dadec9-ba2d-415d-b8c2-a8ccc09db442	1	2022-08-04

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9PHQ9Y1OLM	PREDNISOLONE	50-24-8	PREDNISOLONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
73534-505-01	73534050501	100 TABLET in 1 BOTTLE (73534-505-01)	100 tablet	2022-03-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MILLIPRED™ Tablet (prednisolone tablets USP) Rx only	Avalo Therapeutics Inc.	2024-08-09	HUMAN PRESCRIPTION DRUG LABEL	3