Nardil

Product NDC: 0071-0350
11-digit product format: 000710350
Labeler code: 0071
Product ID: 0071-0350_87512ea9-1c68-4ec1-a8d0-37776f006227
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenelzine Sulfate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Parke-Davis Div of Pfizer Inc
Application: NDA011909
Marketing category: NDA
Marketing start: 1961-06-09
Substance: PHENELZINE SULFATE
Active strength: 15 mg/1
Pharmacologic classes: Monoamine Oxidase Inhibitor [EPC], Monoamine Oxidase Inhibitors [MoA]
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 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
N011909-002	NARDIL	PHENELZINE SULFATE	EQ 15MG BASE	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
N011909-002	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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N011909-002	NARDIL	EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N011909-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011909-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011909-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011909-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011909-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011909-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011909-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011909-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011909-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N011909-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011909-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011909-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011909-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N011909-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N011909-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N011909-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N011909-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N011909-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N011909-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N011909-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N011909-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N011909-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N011909-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N011909-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N011909-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N011909-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N011909-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N011909-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N011909-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N011909-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N011909-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N011909-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N011909-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N011909-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N011909-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N011909-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N011909-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N011909-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N011909-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N011909-002	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENELZINE SULFATE	15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2681D7P965	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
104836	Internal RxNorm lookup
312347	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
513a41d0-37d4-4355-8a6d-a2c643bce6fa	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
0cd971f4-e45f-4585-82c3-177043058d35	Product name	1	20170614
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	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
0071-0350-60	Nardil	60 in 1 BOTTLE	TABLET, FILM COATED	60		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0071-0350-60	EA - Each	0071-0350	ca90d127-b835-4239-bbd2-3ff3c72a0428	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENELZINE SULFATE	ACTIVE INGREDIENT	2681D7P965	NARDIL (PHENELZINE SULFATE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	8
PHENELZINE	ACTIVE MOIETY	O408N561GF	NARDIL (PHENELZINE SULFATE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	8
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NARDIL (PHENELZINE SULFATE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	8
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	NARDIL (PHENELZINE SULFATE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	8
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	NARDIL (PHENELZINE SULFATE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NARDIL (PHENELZINE SULFATE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	8
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	NARDIL (PHENELZINE SULFATE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	8
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NARDIL (PHENELZINE SULFATE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	NARDIL (PHENELZINE SULFATE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0071-0350	NARDIL (PHENELZINE SULFATE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	10	Current NDC, Legacy NDC, 1 package rows	20201210_513a41d0-37d4-4355-8a6d-a2c643bce6fa.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
phenelzine sulfate	PHENELZINE SULFATE	Mylan Pharmaceuticals Inc.	fa041652-fdde-4794-a8d2-279dd309e075	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 011909 application number: NDA011909
Nardil	PHENELZINE SULFATE	Parke-Davis Div of Pfizer Inc	513a41d0-37d4-4355-8a6d-a2c643bce6fa	2025-06-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 011909 application number: NDA011909 ndc (product): 0071-0350

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2681D7P965	PHENELZINE SULFATE	156-51-4	PHENELZINE SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
104836	Nardil 15 MG Oral Tablet	PSN	513a41d0-37d4-4355-8a6d-a2c643bce6fa	11
312347	phenelzine sulfate 15 MG Oral Tablet	PSN	513a41d0-37d4-4355-8a6d-a2c643bce6fa	11
104836	phenelzine 15 MG Oral Tablet [Nardil]	SBD	513a41d0-37d4-4355-8a6d-a2c643bce6fa	11
312347	phenelzine 15 MG Oral Tablet	SCD	513a41d0-37d4-4355-8a6d-a2c643bce6fa	11
104836	Nardil (as phenelzine sulfate) 15 MG Oral Tablet	SY	513a41d0-37d4-4355-8a6d-a2c643bce6fa	11
104836	Nardil 15 MG Oral Tablet	SY	513a41d0-37d4-4355-8a6d-a2c643bce6fa	11
312347	phenelzine (as phenelzine sulfate) 15 MG Oral Tablet	SY	513a41d0-37d4-4355-8a6d-a2c643bce6fa	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0071-0350-60	00071035060	60 TABLET, FILM COATED in 1 BOTTLE (0071-0350-60)	1961-06-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NARDIL ® (Phenelzine Sulfate Tablets, USP)	Parke-Davis Div of Pfizer Inc \| Farmea \| Siegfried Evionnaz SA	2025-06-06	HUMAN PRESCRIPTION DRUG LABEL	11