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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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		2026-09-14
excluded package	package	54482-053	54482-053-01	D	Discontinued by firm		2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54482-053-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54482-053-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54482-053-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54482-053-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54482-053-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54482-053-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54482-053-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54482-053-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54482-053-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54482-053-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54482-053-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54482-053-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`caaa826d4ba7…`
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…`

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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

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