Home NDC 68135-482 Kuvan
Product NDC 68135-482
11-digit product format 681350482
Labeler code 68135
Product ID 68135-482_c4286a54-6e01-4444-94a0-943411790e1d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sapropterin dihydrochloride
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler BioMarin Pharmaceutical Inc.
Application NDA205065
Marketing category NDA
Marketing start 2015-05-27
Substance SAPROPTERIN DIHYDROCHLORIDE
Active strength 500 mg/1
Pharmacologic classes Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N205065-001 KUVAN SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET FOR SOLUTION / ORAL AB RLD, RS 2013-12-19 N205065-002 KUVAN SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET FOR SOLUTION / ORAL AB RLD, RS 2015-10-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205065-001 9216178 2032-11-01 Drug product 2016-01-15 N205065-001 9216178*PED 2033-05-01 Pediatric extension N205065-002 9216178 2032-11-01 Drug product 2016-01-15 N205065-002 9216178*PED 2033-05-01 Pediatric extension
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 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD, RS 2015-10-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL RLD 2015-10-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205065-001 KUVAN 100MG/PACKET POWDER / ORAL AB RLD, RS 2013-12-19 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N205065-002 KUVAN 500MG/PACKET POWDER / ORAL AB RLD 2015-10-27 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 observed states.
Observed Orange Book patent history# Patent history page 1 of 22 · 846 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N205065-001 9216178 2032-11-01 Drug product 2016-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205065-001 9216178*PED 2033-05-01 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205065-002 9216178 2032-11-01 Drug product 2016-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205065-002 9216178*PED 2033-05-01 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-001 7566714 2024-11-17 U-1589 2014-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-001 7612073 2024-11-17 U-1010 2014-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-001 8067416 2024-11-17 U-1589 2014-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-001 9433624 2024-11-17 U-1589 2016-10-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-001 RE43797 2024-11-17 U-1590 2014-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-001 7566714*PED 2025-05-17 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-001 7612073*PED 2025-05-17 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-001 8067416*PED 2025-05-17 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-001 9433624*PED 2025-05-17 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-001 RE43797*PED 2025-05-17 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-001 9216178 2032-11-01 Drug product 2016-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-001 9216178*PED 2033-05-01 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-002 7566714 2024-11-17 U-1589 2015-11-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-002 7612073 2024-11-17 U-1010 2015-11-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-002 8067416 2024-11-17 U-1589 2015-11-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-002 9433624 2024-11-17 U-1589 2016-10-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-002 RE43797 2024-11-17 U-1590 2015-11-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-002 7566714*PED 2025-05-17 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-002 7612073*PED 2025-05-17 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-002 8067416*PED 2025-05-17 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-002 9433624*PED 2025-05-17 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-002 RE43797*PED 2025-05-17 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-002 9216178 2032-11-01 Drug product 2016-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205065-002 9216178*PED 2033-05-01 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205065-001 7566714*PED 2025-05-17 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205065-001 7612073*PED 2025-05-17 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205065-001 8067416*PED 2025-05-17 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205065-001 9433624*PED 2025-05-17 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205065-001 RE43797*PED 2025-05-17 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205065-001 9216178 2032-11-01 Drug product 2016-01-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205065-001 9216178*PED 2033-05-01 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205065-002 7566714*PED 2025-05-17 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205065-002 7612073*PED 2025-05-17 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205065-002 8067416*PED 2025-05-17 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205065-002 9433624*PED 2025-05-17 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205065-002 RE43797*PED 2025-05-17 Pediatric extension 6a471c1ec25d…
Additional Listing Data#
Finished product Yes
Brand name base Kuvan
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SAPROPTERIN DIHYDROCHLORIDE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination RG277LF5B3 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1111018 Internal RxNorm lookup 1111020 Internal RxNorm lookup 1486687 Internal RxNorm lookup 1486691 Internal RxNorm lookup 1653217 Internal RxNorm lookup 1653221 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68135-482-10 Kuvan 1 in 1 PACKET POWDER, FOR SOLUTION 1 79 68135-482-11 Kuvan 30 in 1 CARTON POWDER, FOR SOLUTION 30 79
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SAPROPTERIN DIHYDROCHLORIDE ACTIVE INGREDIENT RG277LF5B3 KUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.] 35 SAPROPTERIN ACTIVE MOIETY EGX657432I KUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.] 35 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R KUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.] 35 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J KUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.] 35 CROSPOVIDONE (15 MPA.S AT 5%) INACTIVE INGREDIENT 68401960MK KUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.] 35 MANNITOL INACTIVE INGREDIENT 3OWL53L36A KUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.] 35 POTASSIUM CITRATE INACTIVE INGREDIENT EE90ONI6FF KUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.] 35 RIBOFLAVIN INACTIVE INGREDIENT TLM2976OFR KUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.] 35 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI KUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.] 35 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 KUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.] 35
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68135-482 KUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.] 78 Current NDC, Legacy NDC, 2 package rows 20240912_af38711e-8873-4790-a92d-4d583e23fb89.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 Kuvan SAPROPTERIN DIHYDROCHLORIDE BioMarin Pharmaceutical Inc. af38711e-8873-4790-a92d-4d583e23fb89 2024-08-26 Warnings, Adverse reactions Exact identifier application applno (NDA): 205065 application number: NDA205065 ndc (product): 68135-482
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68135-482-10 68135048210 1 in 1 PACKET Historical 68135-482-11 68135048211 30 PACKET in 1 CARTON (68135-482-11) / 1 POWDER, FOR SOLUTION in 1 PACKET (68135-482-10) 30 packet 2015-05-27 0000-00-00 No No Current