NDC 31722-047-01 - Sapropterin dihydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 31722-047
Requested NDC: 31722-047-01
Package NDCs from labels: 31722-047-01, 31722-047-30, 31722-047-31
Manufacturer: Camber Pharmaceuticals, Inc. | Annora Pharma Private Limited
Effective date: 2026-03-05
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
ASCORBIC ACID - Camber Pharmaceuticals, Inc. \| Annora Pharma Private Limited	Camber Pharmaceuticals, Inc. \| Annora Pharma Private Limited	2026-03-05	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
31722-047-01	Sapropterin dihydrochloride	1 in 1 PACKET	POWDER, FOR SOLUTION	1	3
31722-047-30	Sapropterin dihydrochloride	30 in 1 CARTON	POWDER, FOR SOLUTION	30	3
31722-047-31	Sapropterin dihydrochloride	1 in 1 CARTON	POWDER, FOR SOLUTION	1	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
31722-047	SAPROPTERIN DIHYDROCHLORIDE (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [CAMBER PHARMACEUTICALS, INC.]	2	Current NDC, Legacy NDC, 3 package rows	20240710_3f0d6820-ff59-40c0-882f-aeea2dd1d1ad.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
31722-047-01	EA - Each	31722-047	6d999e39-c76a-4e90-a95f-2b63fee7baf5	1	2023-02-06
31722-047-30	EA - Each	31722-047	678de7e0-b1a3-4e6c-834f-d0a8baadefce	1	2023-02-06

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 14 of 14 · 269 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Food Additives	IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,	Newton Laboratories, Inc.	9aefc830-329c-5e35-e053-2a95a90a6ffe	2020-11-30	Warnings	Exact identifier unii: PQ6CK8PD0R
Food Additives	IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,	Newton Laboratories, Inc.	9af2d6f4-baa8-5da9-e053-2995a90a3dac	2020-11-30	Warnings	Exact identifier unii: PQ6CK8PD0R
GUNA ARTHRO RELIEF	ARTERIA SUIS - ALPHA KETOGLUTARICUM ACIDUM - ALPHA LIPOICUM ACIDUM - ASCORBICUM ACIDUM - BARIUM OXALSUCCINICUM - BRYONIA ALBA - CALCAREA CARBONICA - CARTILAGO SUIS - CHLORINUM - CIMICIFUGA RACEMOSA - COLCHICUM AUTUMNALE - DULCAMARA - EMBRYO SUIS - FUNICULUS UMBILICALIS SUIS - GLANDULA SUPRARENALIS SUIS - NADIDUM - NATRUM OXALACETICUM - NATRUM SULPHURICUM - PLACENTA TOTALIS SUIS - RHUS TOXICODENDRON - SULPHUR- VENA SUIS -	Guna spa	aebb990a-65bc-54ed-e053-2995a90a5682	2020-10-23	Warnings	Exact identifier unii: PQ6CK8PD0R
SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	Par Health USA, LLC	6b2172e4-42fc-42fe-b1ad-9d6a974d4343	2020-07-09	Warnings, Adverse reactions	Exact identifier rxcui: 1111018 unii: RG277LF5B3
GUNA-DIGEST	ANGELICA ARCHANGELICA ROOT - ANISUM - ARTEMISIA ABROTANUM FLOWERING TOP - ASCORBIC ACID - CITRULLUS COLOCYNTHIS FRUIT PULP - GENTIANA LUTEA ROOT - MELATONIN - NIACIN - PANCRELIPASE AMYLASE - PANCRELIPASE LIPASE - PORK LIVER - SEROTONIN - STRYCHNOS NUX-VOMICA SEED - SUS SCROFA DIENCEPHALON - SUS SCROFA DUODENUM - SUS SCROFA GALL BLADDER - SUS SCROFA PANCREAS - SUS SCROFA PYLORUS - THIAMINE HYDROCHLORIDE - TRYPSIN - TRYPTOPHAN -	Guna spa	624228b9-70be-43a1-93a5-f6e708814fa2	2018-12-22	Warnings	Exact identifier unii: PQ6CK8PD0R
GUNA-SINUS NOSE	ALTHAEA OFFICINALIS LEAF - ASCORBIC ACID - BLACK CURRANT - CALCIUM SULFIDE - COPPER - ECHINACEA ANGUSTIFOLIA - GOLDENSEAL - LACHESIS MUTA VENOM - LOBARIA PULMONARIA - MANGANESE - MERCURIC SULFIDE - ONION - PLANTAGO MAJOR - POTASSIUM CARBONATE - PULSATILLA VULGARIS - SILICON DIOXIDE - SILVER NITRATE - SINUSITISINUM - SUS SCROFA NASAL MUCOSA - SUS SCROFA THYMUS - SUS SCROFA URINARY BLADDER -	Guna spa	36fef678-17c6-4d2a-a0f0-ddb298611f25	2018-12-22	Warnings	Exact identifier unii: PQ6CK8PD0R
GUNA-RHINO NOSE	APIS MELLIFERA - ARALIA RACEMOSA ROOT - ASCORBIC ACID - BLACK CURRANT - COPPER - EUPHORBIA RESINIFERA RESIN - EUROPEAN ELDERBERRY - HELIANTHEMUM CANADENSE - HISTAMINE DIHYDROCHLORIDE - HUMAN INTERLEUKIN 12 - HUMAN INTERLEUKIN-10 (NONGLYCOSYLATED) - INTERFERON GAMMA-1B - MANGANESE GLUCONATE - MELILOTUS - ONION - PLANTAGO MAJOR - ROSA CANINA FRUIT - SILVER NITRATE -	Guna spa	5baeb698-1735-4586-9984-2a2cb0da871a	2018-12-21	Warnings	Exact identifier unii: PQ6CK8PD0R
OMEOSPORT	.ALPHA.-KETOGLUTARIC ACID - ACONITIC ACID, CIS - ADENOSINE TRIPHOSPHATE - ALPHA LIPOIC ACID - ASCORBIC ACID - ASIAN GINSENG - BARIUM CATION - BEET - CEROUS OXALATE NONAHYDRATE - COENZYME A - CYSTEINE - FUMARIC ACID - LACTIC ACID, DL - MAGNESIUM CARBONATE - MALIC ACID - MANGANESE PHOSPHATE, DIBASIC - PORK - PYRIDOXINE HYDROCHLORIDE - RIBOFLAVIN - SODIUM DIETHYL OXALACETATE - SODIUM PYRUVATE - SUCCINIC ACID - SUS SCROFA ADRENAL GLAND - THIAMINE HYDROCHLORIDE - SUS SCROFA EMBRYO -	Guna spa	119a205d-0074-48ff-ac78-e2300db45227	2018-12-21	Warnings	Exact identifier unii: PQ6CK8PD0R
Immuno Fortifier	ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LIGUSTICUM PORTERI, MYRRHA, NASTURTIUM AQUATICUM, TABEBUIA IMPETIGINOSA, TRIGONELLA FOENUM-GRAECUM, ASCORBIC ACID, PINUS SYLVESTRIS, LYMPH (SUIS), MEDULLA OSSIS SUIS, SPLEEN (SUIS), THYMUS (SUIS), HEPAR SULPHURIS CALCAREUM, PHOSPHORICUM ACIDUM, SILICEA	BioActive Nutritional, Inc.	04024663-0b11-438a-a21a-8e86edd8052a	2018-01-15	Warnings	Exact identifier unii: PQ6CK8PD0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.