Depen

Product NDC: 0037-4401
11-digit product format: 000374401
Labeler code: 0037
Product ID: 0037-4401_d5cb9986-f53c-4f8c-acb9-d5bdff6f07b2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Penicillamine
Dosage form: TABLET
Route: ORAL
Labeler: Viatris Specialty LLC
Application: NDA019854
Marketing category: NDA
Marketing start: 1978-11-30
Substance: PENICILLAMINE
Active strength: 250 mg/1
Pharmacologic classes: Antirheumatic Agent [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 42.

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
N019854-001	DEPEN	PENICILLAMINE	250MG	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
N019854-001	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 · 42 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
2026-08-18 06:07:40	2026-07	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019854-001	DEPEN	250MG	TABLET / ORAL		RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019854-001	DEPEN	250MG	TABLET / ORAL		RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019854-001	DEPEN	250MG	TABLET / ORAL		RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019854-001	DEPEN	250MG	TABLET / ORAL		RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019854-001	DEPEN	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N019854-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019854-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019854-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019854-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019854-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019854-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019854-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019854-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019854-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019854-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019854-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019854-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019854-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019854-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019854-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019854-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019854-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019854-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N019854-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019854-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019854-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019854-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019854-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019854-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019854-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019854-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019854-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019854-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019854-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019854-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019854-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019854-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019854-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019854-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019854-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019854-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019854-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019854-001	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PENICILLAMINE	250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
GNN1DV99GX	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198071	Internal RxNorm lookup
207370	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
38f8ae60-b354-11de-8a39-0800200c9a66	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4c108ea3-9ba7-fa75-c564-24ad70498a68	Product name	5	20220224
0e1adcb6-6a1d-c55b-4ff0-e09ab9548f27	Product name	3	20210602

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0037-4401-01	Depen	100 in 1 BOTTLE	TABLET	100		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0037-4401-01	EA - Each	0037-4401	19e2faf3-7bfa-4d0a-a398-414d5bf19b88	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
PENICILLAMINE	ACTIVE INGREDIENT	GNN1DV99GX	DEPEN (PENICILLAMINE) TABLET [MEDA PHARMACEUTICALS INC.]	2
PENICILLAMINE	ACTIVE MOIETY	GNN1DV99GX	DEPEN (PENICILLAMINE) TABLET [MEDA PHARMACEUTICALS INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0037-4401	DEPEN (PENICILLAMINE) TABLET [MEDA PHARMACEUTICALS INC.]	6	Current NDC, Legacy NDC, 1 package rows	20231102_38f8ae60-b354-11de-8a39-0800200c9a66.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
Depen	PENICILLAMINE	Viatris Specialty LLC	38f8ae60-b354-11de-8a39-0800200c9a66	2025-09-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019854 application number: NDA019854 ndc (product): 0037-4401

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
GNN1DV99GX	PENICILLAMINE	52-67-5	PENICILLAMINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
207370	Depen Titratable Tablets 250 MG Oral Tablet	PSN	38f8ae60-b354-11de-8a39-0800200c9a66	8
198071	penicillAMINE 250 MG Oral Tablet	PSN	38f8ae60-b354-11de-8a39-0800200c9a66	8
207370	penicillamine 250 MG Oral Tablet [Depen]	SBD	38f8ae60-b354-11de-8a39-0800200c9a66	8
198071	penicillamine 250 MG Oral Tablet	SCD	38f8ae60-b354-11de-8a39-0800200c9a66	8
207370	Depen 250 MG Oral Tablet	SY	38f8ae60-b354-11de-8a39-0800200c9a66	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0037-4401-01	00037440101	100 TABLET in 1 BOTTLE (0037-4401-01)	100 tablet	1978-11-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DEPEN® (penicillamine tablets, USP) Titratable Tablets	Viatris Specialty LLC	2025-09-21	HUMAN PRESCRIPTION DRUG LABEL	8