Matulane

Product NDC: 54482-053
11-digit product format: 544820053
Labeler code: 54482
Product ID: 54482-053_97f59bac-2506-a98b-e053-2a95a90a8030
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: procarbazine hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Sigma-Tau Pharmaceuticals, Inc.
Application: NDA016785
Marketing category: NDA
Marketing start: 1985-12-27
Marketing end: 2020-03-31
Substance: PROCARBAZINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Alkylating Activity [MoA],Alkylating Drug [EPC]
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	54482-053		D	Discontinued by firm		2026-08-03
excluded package	package	54482-053	54482-053-01	D	Discontinued by firm		2026-08-03

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
N016785-001	MATULANE	PROCARBAZINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL		RLD, RS, Approved before 1982

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`cb3db0bc1861…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Matulane	PROCARBAZINE HYDROCHLORIDE	Leadiant Biosciences, Inc.	1aa75a3a-18c9-49e1-91a6-293d0b7da756	2024-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 016785 application number: NDA016785

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54482-053-01	EA - Each	54482-053	0f4cda35-a574-4e64-8a78-3824b87fb401	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PROCARBAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	XH0NPH5ZX8	MATULANE (PROCARBAZINE HYDROCHLORIDE) CAPSULE [SIGMA-TAU PHARMACEUTICALS, INC.]	5
PROCARBAZINE	ACTIVE MOIETY	35S93Y190K	MATULANE (PROCARBAZINE HYDROCHLORIDE) CAPSULE [SIGMA-TAU PHARMACEUTICALS, INC.]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	MATULANE (PROCARBAZINE HYDROCHLORIDE) CAPSULE [SIGMA-TAU PHARMACEUTICALS, INC.]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	MATULANE (PROCARBAZINE HYDROCHLORIDE) CAPSULE [SIGMA-TAU PHARMACEUTICALS, INC.]	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	MATULANE (PROCARBAZINE HYDROCHLORIDE) CAPSULE [SIGMA-TAU PHARMACEUTICALS, INC.]	5
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	MATULANE (PROCARBAZINE HYDROCHLORIDE) CAPSULE [SIGMA-TAU PHARMACEUTICALS, INC.]	5
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	MATULANE (PROCARBAZINE HYDROCHLORIDE) CAPSULE [SIGMA-TAU PHARMACEUTICALS, INC.]	5
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	MATULANE (PROCARBAZINE HYDROCHLORIDE) CAPSULE [SIGMA-TAU PHARMACEUTICALS, INC.]	5
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	MATULANE (PROCARBAZINE HYDROCHLORIDE) CAPSULE [SIGMA-TAU PHARMACEUTICALS, INC.]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MATULANE (PROCARBAZINE HYDROCHLORIDE) CAPSULE [SIGMA-TAU PHARMACEUTICALS, INC.]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	MATULANE (PROCARBAZINE HYDROCHLORIDE) CAPSULE [SIGMA-TAU PHARMACEUTICALS, INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MATULANE (PROCARBAZINE HYDROCHLORIDE) CAPSULE [SIGMA-TAU PHARMACEUTICALS, INC.]	5

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
XH0NPH5ZX8	PROCARBAZINE HYDROCHLORIDE	366-70-1	PROCARBAZINE HYDROCHLORIDE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MATULANE ® (procarbazine hydrochloride) Capsules	Sigma-Tau Pharmaceuticals, Inc. \| F.I.S. Fabbrica Italiana Sintetici S.p.A. \| Alcami Carolinas Corporation	2019-11-22	HUMAN PRESCRIPTION DRUG LABEL	8