Matulane

Product NDC: 54482-054
11-digit product format: 544820054
Labeler code: 54482
Product ID: 54482-054_63cfdccc-7bfd-44a1-894e-236292c7ea47
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-10-15 13:18:30	2026-09	N016785-001	MATULANE	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS, Approved before 1982	`c2088c7a36db…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Matulane
Listing expiration: 2027-12-31

Active Ingredients#

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

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

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