Penicillamine

Product NDC
0591-4171
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct0591-4171UNFINISHEDActive or certified unfinished drug listing2026-08-17
unfinished packagepackage0591-41710591-4171-00UNFINISHEDActive or certified unfinished drug listing2026-08-17

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 · 40 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05unfinished productproducta6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage0591-4171-00a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-26unfinished productproduct1d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage0591-4171-001d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14unfinished productproduct390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage0591-4171-00390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31unfinished productproducte30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage0591-4171-00e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28unfinished productproductbbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage0591-4171-00bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductf268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage0591-4171-00f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductf764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage0591-4171-00f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproduct68b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage0591-4171-0068b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproduct05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage0591-4171-0005c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-08unfinished productproduct48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage0591-4171-0048b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-08unfinished productproduct27f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage0591-4171-0027f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-09unfinished productproduct8d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage0591-4171-008d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished productproductd1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage0591-4171-00d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-14unfinished productproduct50b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage0591-4171-0050b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08unfinished productproduct906f6e251498…bf70b80e44f0…
2022-04-09 23:13 UTC · source 2022-04-08unfinished packagepackage0591-4171-00906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-27unfinished productproduct6db9cb8d1e19…3449e1ec5b70…
2021-12-27 23:28 UTC · source 2021-12-27unfinished packagepackage0591-4171-006db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-18unfinished productproduct8fc7167e32ce…e96bbc724034…
2021-02-18 23:40 UTC · source 2021-02-18unfinished packagepackage0591-4171-008fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-17unfinished productproduct4184dd79f89f…545327b3e20f…
2020-12-18 03:04 UTC · source 2020-12-17unfinished packagepackage0591-4171-004184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished productproduct4bd3596a7b87…5c64c6f6865f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished packagepackage0591-4171-004bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05unfinished productproduct263afe128892…91768de4ddbe…
2019-12-08 06:16 UTC · source 2019-12-05unfinished packagepackage0591-4171-00263afe128892…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210976-001PENICILLAMINEPENICILLAMINE250MGCAPSULE / ORALAB2019-06-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210976-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-243f01610625f2…
2019-09-15 20:21 UTC2019-09A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-24b00525d2431f…
2019-07-19 19:46 UTC2019-07A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210976-001PENICILLAMINE250MGCAPSULE / ORALAB2019-06-24e64feba35796…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A210976-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210976-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210976-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210976-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210976-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210976-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210976-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210976-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210976-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210976-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210976-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210976-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210976-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210976-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210976-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210976-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210976-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210976-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210976-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210976-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210976-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210976-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A210976-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210976-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210976-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210976-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A210976-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A210976-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210976-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210976-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210976-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210976-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210976-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210976-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210976-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A210976-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A210976-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210976-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210976-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210976-001AB1e64feba35796…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12A210976-001CGT2019-12-2274a2ff9319b5…
2019-12-14 00:12 UTC2019-12A210976-001CGT2019-12-223f01610625f2…
2019-09-15 20:21 UTC2019-09A210976-001CGT2019-12-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A210976-001CGT2019-12-22ea99ee380514…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PENICILLAMINE250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
GNN1DV99GXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198070Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
594d7a82-af1d-41c4-98ee-0ea6895fc237Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4c108ea3-9ba7-fa75-c564-24ad70498a68Product name520220224
0e1adcb6-6a1d-c55b-4ff0-e09ab9548f27Product name320210602

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-4171-01Penicillamine100 in 1 BOTTLECAPSULE1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-4171-01EA - Each0591-417149e58390-99f0-4c47-b2f3-f48332513f9012019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-4171PENICILLAMINE CAPSULE [ACTAVIS PHARMA, INC.]3Current NDC, Legacy NDC, 1 package rows20241109_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PenicillaminePENICILLAMINEActavis Pharma, Inc.594d7a82-af1d-41c4-98ee-0ea6895fc2372024-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210976
application number: ANDA210976
ndc (product): 0591-4171

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198070penicillAMINE 250 MG Oral CapsulePSN594d7a82-af1d-41c4-98ee-0ea6895fc2374
198070penicillamine 250 MG Oral CapsuleSCD594d7a82-af1d-41c4-98ee-0ea6895fc2374

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-4171-00005914171006234 CAPSULE in 1 BOX (0591-4171-00)6234 capsule25-JUN-1930-JUN-27Historical
0591-4171-0100591417101100 CAPSULE in 1 BOTTLE (0591-4171-01) 100 capsule2019-06-250000-00-00NoNoCurrent