Matulane

Product NDC: 54482-054
11-digit product format: 544820054
Labeler code: 54482
Product ID: 54482-054_caa705fa-c467-49b5-a7cb-ae2c8b872a86
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: procarbazine hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Leadiant Biosciences, Inc.
Application: NDA016785
Marketing category: NDA
Marketing start: 1985-12-27
Substance: PROCARBAZINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Matulane
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PROCARBAZINE HYDROCHLORIDE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
XH0NPH5ZX8	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
207588	Internal RxNorm lookup
314167	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1aa75a3a-18c9-49e1-91a6-293d0b7da756	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
9959d3f4-2b18-1fd3-aaf3-9a802c197175	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54482-054-01	Matulane	100 in 1 BOTTLE	CAPSULE	100		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54482-054-01	EA - Each	54482-054	5984c775-4812-4aa3-8d37-0606f27faeb5	1	2018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54482-054	MATULANE (PROCARBAZINE HYDROCHLORIDE) CAPSULE [LEADIANT BIOSCIENCES, INC.]	9	Current NDC, Legacy NDC, 1 package rows	20240925_1aa75a3a-18c9-49e1-91a6-293d0b7da756.zip

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 ndc (product): 54482-054

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
207588	Matulane 50 MG Oral Capsule	PSN	1aa75a3a-18c9-49e1-91a6-293d0b7da756	9
314167	procarbazine HCl 50 MG Oral Capsule	PSN	1aa75a3a-18c9-49e1-91a6-293d0b7da756	9
207588	procarbazine 50 MG Oral Capsule [Matulane]	SBD	1aa75a3a-18c9-49e1-91a6-293d0b7da756	9
314167	procarbazine 50 MG Oral Capsule	SCD	1aa75a3a-18c9-49e1-91a6-293d0b7da756	9
207588	Matulane 50 MG Oral Capsule	SY	1aa75a3a-18c9-49e1-91a6-293d0b7da756	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54482-054-01	54482005401	100 CAPSULE in 1 BOTTLE (54482-054-01)	100 capsule	1985-12-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MATULANE ® (procarbazine hydrochloride) Capsules	Leadiant Biosciences, Inc.	2024-09-16	HUMAN PRESCRIPTION DRUG LABEL	9