Sapropterin dihydrochloride

Product NDC: 72603-194
Requested package NDC: 72603-194-30
11-digit product format: 726030194
Labeler code: 72603
Product ID: 72603-194_1ccf4222-e182-b467-e063-6394a90a76ec
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sapropterin dihydrochloride
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: NorthStar RxLLC
Application: ANDA215420
Marketing category: ANDA
Marketing start: 2023-12-01
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
A215420-001	SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	FOR SOLUTION / ORAL	AB		2022-08-18
A215420-002	SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	FOR SOLUTION / ORAL	AB		2022-08-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A215420-001	AB
A215420-002	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 · 54 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
2026-02-19 14:30 UTC	2026-02	A215420-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2022-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215420-002	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER / ORAL	AB	2022-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215420-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2022-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215420-002	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER / ORAL	AB	2022-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215420-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2022-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215420-002	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER / ORAL	AB	2022-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215420-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2022-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215420-002	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER / ORAL	AB	2022-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215420-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2022-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215420-002	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER / ORAL	AB	2022-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215420-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2022-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215420-002	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER / ORAL	AB	2022-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215420-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2022-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215420-002	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER / ORAL	AB	2022-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215420-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2022-08-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215420-002	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER / ORAL	AB	2022-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215420-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2022-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215420-002	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER / ORAL	AB	2022-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215420-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2022-08-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215420-002	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER / ORAL	AB	2022-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215420-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2022-08-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215420-002	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER / ORAL	AB	2022-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215420-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2022-08-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215420-002	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER / ORAL	AB	2022-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215420-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2022-08-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215420-002	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER / ORAL	AB	2022-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215420-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2022-08-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215420-002	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER / ORAL	AB	2022-08-18	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215420-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2022-08-18	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215420-002	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER / ORAL	AB	2022-08-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215420-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2022-08-18	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215420-002	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER / ORAL	AB	2022-08-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215420-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2022-08-18	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215420-002	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER / ORAL	AB	2022-08-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215420-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2022-08-18	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215420-002	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER / ORAL	AB	2022-08-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215420-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2022-08-18	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215420-002	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER / ORAL	AB	2022-08-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215420-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2022-08-18	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215420-002	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER / ORAL	AB	2022-08-18	`a67488948f0b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 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	A215420-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215420-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215420-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215420-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215420-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215420-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215420-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215420-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215420-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215420-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215420-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215420-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215420-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215420-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215420-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215420-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215420-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215420-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215420-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215420-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215420-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215420-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215420-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215420-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215420-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215420-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215420-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215420-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215420-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215420-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215420-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215420-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215420-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215420-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215420-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215420-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215420-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215420-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215420-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215420-002	AB	1	`a67488948f0b…`

Additional Listing Data#

Finished product: Yes
Brand name base: Sapropterin dihydrochloride
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1111018	Internal RxNorm lookup
1653217	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
b3999f74-920d-4444-afa7-f4211e4eb431	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8c453acf-b173-4ab3-9044-65304cdd78bf	Product name	5	20260211
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72603-194-01	Sapropterin dihydrochloride	1 in 1 PACKET	POWDER, FOR SOLUTION	1		3
72603-194-30	Sapropterin dihydrochloride	30 in 1 CARTON	POWDER, FOR SOLUTION	30		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72603-194-01	EA - Each	72603-194	48724ae9-c801-4bc0-9e1e-11de0fb3b19b	1	2024-07-12
72603-194-30	EA - Each	72603-194	9158e7b3-b6d9-48d7-976e-cba67d2c055b	1	2023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72603-194	SAPROPTERIN DIHYDROCHLORIDE (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [NORTHSTAR RXLLC]	3	Current NDC, 2 package rows	20240710_b3999f74-920d-4444-afa7-f4211e4eb431.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sapropterin dihydrochloride	SAPROPTERIN DIHYDROCHLORIDE	Camber Pharmaceuticals, Inc.	3f0d6820-ff59-40c0-882f-aeea2dd1d1ad	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215420 application number: ANDA215420
Sapropterin dihydrochloride	SAPROPTERIN DIHYDROCHLORIDE	NorthStar RxLLC	b3999f74-920d-4444-afa7-f4211e4eb431	2024-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215420 application number: ANDA215420 ndc (package): 72603-194-30 ndc (product): 72603-194 ndc11 (package): 72603019430

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
RG277LF5B3	SAPROPTERIN DIHYDROCHLORIDE	69056-38-8	SAPROPTERIN DIHYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1111018	sapropterin dihydrochloride 100 MG Powder for Oral Solution	PSN	b3999f74-920d-4444-afa7-f4211e4eb431	3
1653217	sapropterin dihydrochloride 500 MG Powder for Oral Solution	PSN	b3999f74-920d-4444-afa7-f4211e4eb431	3
1111018	sapropterin dihydrochloride 100 MG Powder for Oral Solution	SCD	b3999f74-920d-4444-afa7-f4211e4eb431	3
1653217	sapropterin dihydrochloride 500 MG Powder for Oral Solution	SCD	b3999f74-920d-4444-afa7-f4211e4eb431	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72603-194-30	72603019430	30 PACKET in 1 CARTON (72603-194-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (72603-194-01)	30 packet	2023-12-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sapropterin dihydrochloride	NorthStar RxLLC \| Annora Pharma Private Limited	2024-07-09	HUMAN PRESCRIPTION DRUG LABEL	3