Nardil Phenelzine Sulfate

Product NDC: 24822-350
11-digit product format: 248220350
Labeler code: 24822
Product ID: 24822-350_ba71c2fb-1b5c-5eaf-e053-2a95a90ad672
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PHENELZINE SULFATE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Farmea
Application: NDA011909
Marketing category: NDA
Marketing start: 1961-06-09
Marketing end: 0000-00-00
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: 2022-12-31
Current FDA listing: Historical FDA.report record

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…`

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

Nardil Phenelzine Sulfate

Orange Book products#

Therapeutic equivalence codes#

Observed Orange Book product history#

Observed Orange Book normalized TE history#

openFDA label cross-check#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#