NDC 43598-477-11 - 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
- 43598-477
- Requested NDC
- 43598-477-11
- Package NDCs from labels
- 43598-477-11, 43598-477-30
- Manufacturer
- Dr. Reddys Laboratories Inc | Dr. Reddys Laboratories Limited (SEZ UNIT)
- Effective date
- 2024-08-23
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Sapropterin Dihydrochloride - Dr. Reddys Laboratories Inc | Dr. Reddys Laboratories Limited (SEZ UNIT) | Dr. Reddys Laboratories Inc | Dr. Reddys Laboratories Limited (SEZ UNIT) | 2024-08-23 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43598-477-11 | EA - Each | 43598-477 | 65021f2a-f1de-4221-bef9-b62ce1889071 | 1 | 2021-05-05 |
| 43598-477-30 | EA - Each | 43598-477 | 2ebbfc37-012e-48b4-8612-96e17079c606 | 1 | 2021-05-05 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| M-Natal Plus | VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, THIAMINE, RIBOFLAVIN, NIACIN, VITAMIN B6, FOLIC ACID, VITAMIN B12, CALCIUM, IRON, ZINC, COPPER | Bryant Ranch Prepack | 790a9ec0-eb61-4148-86e9-91439e4dce89 | 2026-03-27 | Warnings | PQ6CK8PD0R |
| Potassium Citrate | POTASSIUM CITRATE | Bryant Ranch Prepack | 6271d84e-d991-4bb8-ac9f-6d5cc879b631 | 2026-03-25 | Warnings, Adverse reactions | EE90ONI6FF |
| Potassium Citrate | POTASSIUM CITRATE | Bryant Ranch Prepack | 595343aa-b760-4158-9c49-dd5368f45e2c | 2026-03-25 | Warnings, Adverse reactions | EE90ONI6FF |
| Multivitamin with Fluoride | .ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN D | Bryant Ranch Prepack | f28c8928-81c3-458a-9ce2-2aaca3b7527d | 2026-03-18 | Warnings, Adverse reactions | PQ6CK8PD0R |
| Multivitamin with Fluoride | .ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN D | Bryant Ranch Prepack | ef79cadb-c553-4af1-9a53-6ea1ab26b4bb | 2026-03-18 | Warnings, Adverse reactions | PQ6CK8PD0R |
| Adaptagen | ARALIA QUINQUEFOLIA, AVENA SATIVA, CAPSICUM ANNUUM, GINKGO BILOBA, GLYCYRRHIZA GLABRA, HYDROCOTYLE ASIATICA, THIAMINUM HYDROCHLORICUM, ASCORBICUM ACIDUM, RIBOFLAVINUM, GLANDULA SUPRARENALIS SUIS, SPLEEN (SUIS), THYROIDINUM (SUIS), CUPRUM GLUCONATE, IODIUM, LEDUM PALUSTRE, MOLYBDENUM METALLICUM, NATRUM CARBONICUM, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, SELENIUM METALLICUM, SEPIA, VANADIUM METALLICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM | BioActive Nutritional, Inc. | 9404d71c-8a2e-4e68-bf48-8536bb14fc88 | 2026-03-18 | Warnings | PQ6CK8PD0R |
| Tri-Vite Drops with Fluoride | ASCORBIC ACID, SODIUM FLUORIDE, VITAMIN A AND VITAMIN D | Bryant Ranch Prepack | fe9da1e9-9b36-4702-bec2-13187f0f6548 | 2026-03-18 | Warnings, Adverse reactions | PQ6CK8PD0R |
| M-Natal Plus | VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, THIAMINE, RIBOFLAVIN, NIACIN, VITAMIN B6, FOLIC ACID, VITAMIN B12, CALCIUM, IRON, ZINC, COPPER | Bryant Ranch Prepack | f9f15374-4809-4b96-8a07-3c2f1011d110 | 2026-03-18 | Warnings | PQ6CK8PD0R |
| Multivitamin with Fluoride | .ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN D | Bryant Ranch Prepack | 6607fcec-2da9-47df-ad92-1d545f7bf535 | 2026-03-17 | Warnings, Adverse reactions | PQ6CK8PD0R |
| Multivitamin with Fluoride | .ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN D | Bryant Ranch Prepack | 3c3acbdd-0bcb-4798-b6c5-242bdcd352b1 | 2026-03-17 | Warnings, Adverse reactions | PQ6CK8PD0R |
| Multivitamin with Fluoride | .ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN D | Bryant Ranch Prepack | 5568579f-3445-4f04-a936-33c78b33392c | 2026-03-17 | Warnings, Adverse reactions | PQ6CK8PD0R |
| Multivitamin with Fluoride | .ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN D | Bryant Ranch Prepack | b7f1c321-5a00-4b89-8cb4-fa250e74d9db | 2026-03-17 | Warnings, Adverse reactions | PQ6CK8PD0R |
| Sapropterin dihydrochloride | SAPROPTERIN DIHYDROCHLORIDE | Camber Pharmaceuticals, Inc. | 3f0d6820-ff59-40c0-882f-aeea2dd1d1ad | 2026-03-05 | Warnings, Adverse reactions | RG277LF5B3 |
| Osteoplex | EQUISETUM HYEMALE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, MANGANUM MURIATICUM, SYMPHYTUM OFFICINALE, MEDULLA OSSIS SUIS, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEA, PARATHYROID GLAND (SUIS), LIGAMENT (SUIS) | BioActive Nutritional, Inc. | 8a7e1397-a387-4f2c-ab4f-7f1a7f1a849b | 2026-03-05 | Warnings | PQ6CK8PD0R |
| PNV-DHA | ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CALCIUM, FERROUS FUMARATE, DOCONEXENT | Acella Pharmaceuticals, LLC | 576e8bbb-1625-493c-85da-43caf2f02e3c | 2026-03-04 | Boxed warning, Warnings, Adverse reactions | PQ6CK8PD0R |
| Tricitrates | TRICITRATES | Chartwell Governmental & Specialty RX, LLC. | c4ff0407-3930-4c48-afd4-d2cb3e1b18f4 | 2026-02-25 | Warnings, Adverse reactions | EE90ONI6FF |
| Potassium Citrate and Citric Acid | POTASSIUM CITRATE AND CITRIC ACID | Chartwell Governmental & Specialty RX, LLC. | fd57a176-7faf-4053-b348-6ba5f192f05a | 2026-02-25 | Warnings, Adverse reactions | EE90ONI6FF |
| Folartex | MULTIVITAMIN | Oncora Pharma, LLC | 0a4cb0ab-565f-45e8-a989-740bccef21cd | 2026-02-25 | Warnings, Adverse reactions | PQ6CK8PD0R |
| sapropterin dihydrochloride | SAPROPTERIN DIHYDROCHLORIDE | Camber Pharmaceuticals, Inc. | ec8ea96c-8ec1-4301-a85d-d59562e548ca | 2026-02-24 | Warnings, Adverse reactions | RG277LF5B3 |
| Sapropterin Dihydrochloride | SAPROPTERIN DIHYDROCHLORIDE | TRUPHARMA, LLC | 39f1d020-4359-401b-88a8-ed25eaa40b45 | 2026-02-18 | Warnings, Adverse reactions | RG277LF5B3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.