Penicillamine

Product NDC: 0591-4171
Requested package NDC: 0591-4171-00
11-digit product format: 005914171
Labeler code: 0591
Product ID: 0591-4171_24e42ecc-c15e-499d-85a9-bf4b5e277bea
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Penicillamine
Dosage form: CAPSULE
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA210976
Marketing category: ANDA
Marketing start: 2019-06-25
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	0591-4171	0591-4171-00	UNFINISHED	Active or certified unfinished drug listing		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 20 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	`263afe128892…`	`91768de4ddbe…`

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
A210976-001	PENICILLAMINE	PENICILLAMINE	250MG	CAPSULE / ORAL	AB		2019-06-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A210976-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210976-001	PENICILLAMINE	250MG	CAPSULE / ORAL	AB	2019-06-24	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A210976-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210976-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210976-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210976-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210976-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210976-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210976-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210976-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210976-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210976-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210976-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210976-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210976-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210976-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210976-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210976-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210976-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210976-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210976-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210976-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210976-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210976-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210976-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210976-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210976-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210976-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210976-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210976-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210976-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210976-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210976-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210976-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210976-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210976-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210976-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210976-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210976-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210976-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210976-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210976-001	AB	1	`e64feba35796…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A210976-001	CGT	2019-12-22	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A210976-001	CGT	2019-12-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210976-001	CGT	2019-12-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210976-001	CGT	2019-12-22	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: Penicillamine
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198070	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
594d7a82-af1d-41c4-98ee-0ea6895fc237	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
0591-4171-01	Penicillamine	100 in 1 BOTTLE	CAPSULE	100		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-4171-01	EA - Each	0591-4171	49e58390-99f0-4c47-b2f3-f48332513f90	1	2019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-4171	PENICILLAMINE CAPSULE [ACTAVIS PHARMA, INC.]	3	Current NDC, Legacy NDC, 1 package rows	20241109_594d7a82-af1d-41c4-98ee-0ea6895fc237.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
Penicillamine	PENICILLAMINE	Actavis Pharma, Inc.	594d7a82-af1d-41c4-98ee-0ea6895fc237	2024-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210976 application number: ANDA210976 ndc (product): 0591-4171

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
198070	penicillAMINE 250 MG Oral Capsule	PSN	594d7a82-af1d-41c4-98ee-0ea6895fc237	4
198070	penicillamine 250 MG Oral Capsule	SCD	594d7a82-af1d-41c4-98ee-0ea6895fc237	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Status
0591-4171-00	00591417100	6234 CAPSULE in 1 BOX (0591-4171-00)	6234 capsule	25-JUN-19	30-JUN-27	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Penicillamine Capsules, USP Rx only	Actavis Pharma, Inc.	2024-09-25	HUMAN PRESCRIPTION DRUG LABEL	4