NDC 59746-446-13 - Rizatriptan Benzoate

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: 59746-446
Requested NDC: 59746-446-13
Package NDCs from labels: 59746-446-13, 59746-446-14
Manufacturer: Jubilant Cadista Pharmaceuticals Inc. | Jubilant Generics Limited
Effective date: 2018-12-14
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Rizatriptan - Jubilant Cadista Pharmaceuticals Inc. \| Jubilant Generics Limited	Jubilant Cadista Pharmaceuticals Inc. \| Jubilant Generics Limited	2018-12-14	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59746-446-14	2026-01-05	C162847	48780-1	f386c649-c5a4-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use rizatriptan benzoate orally disintegrating tablets safely and effectively. See full prescribing information for rizatriptan benzoate orally disintegrating tablets. Rizatriptan Benzoate Orally Disintegrating Tablets Initial U.S. Approval: 1998
59746-446-14	2023-01-30	C162847	48780-1	f386c649-c5a4-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use rizatriptan benzoate orally disintegrating tablets safely and effectively. See full prescribing information for rizatriptan benzoate orally disintegrating tablets. Rizatriptan Benzoate Orally Disintegrating Tablets Initial U.S. Approval: 1998

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59746-446	RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]	6	Legacy NDC	20181217_42454df9-ffd1-d8c0-f6fb-05198ad8a432.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Rizatriptan Benzoate	ACTIVE INGREDIENT	WR978S7QHH	RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]	3
Rizatriptan	ACTIVE MOIETY	51086HBW8G	RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]	3
Acesulfame Potassium	INACTIVE INGREDIENT	23OV73Q5G9	RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]	3
Crospovidone	INACTIVE INGREDIENT	68401960MK	RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]	3
Ethylcelluloses	INACTIVE INGREDIENT	7Z8S9VYZ4B	RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]	3
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]	3
Mannitol	INACTIVE INGREDIENT	3OWL53L36A	RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]	3
Peppermint	INACTIVE INGREDIENT	V95R5KMY2B	RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]	3
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]	3
Sodium Stearyl Fumarate	INACTIVE INGREDIENT	7CV7WJK4UI	RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]	3
Strawberry	INACTIVE INGREDIENT	4J2TY8Y81V	RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]	3

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 30 of 34 · 674 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Warts	ANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUM	Newton Laboratories, Inc.	f0315c9e-8922-c0b5-e053-2a95a90ae54e	2022-12-19	Warnings	Exact identifier unii: ETJ7Z6XBU4
Warts	ANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUM	Newton Laboratories, Inc.	f031e256-fca5-3939-e053-2995a90a4fe6	2022-12-19	Warnings	Exact identifier unii: ETJ7Z6XBU4
SILICEA	SILICON DIOXIDE	Hyland's Inc.	86da31ff-b39a-4ac2-92e5-810f6d8888e6	2022-12-19	Warnings	Exact identifier unii: ETJ7Z6XBU4
Warts	ANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUM	Newton Laboratories, Inc.	f0328097-e5d2-3532-e053-2a95a90a93f0	2022-12-19	Warnings	Exact identifier unii: ETJ7Z6XBU4
Warts	ANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUM	Newton Laboratories, Inc.	f032e7bb-a6fd-2951-e053-2a95a90a8c3a	2022-12-19	Warnings	Exact identifier unii: ETJ7Z6XBU4
Silicea	SILICON DIOXIDE	Hyland's Inc.	d3c426ab-1a61-3494-e053-2a95a90a9677	2022-12-14	Warnings	Exact identifier unii: ETJ7Z6XBU4
Silicea	SILICEA	Hahnemann Laboratories, INC.	efcdc393-5dab-38d1-e053-2995a90acb2e	2022-12-14		Exact identifier unii: ETJ7Z6XBU4
Defend Cold and Mucus	BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PATENS, RUMEX CRISPUS ROOT, AND SILICON DIOXIDE	Hyland's Inc.	bb851be1-0528-4199-91e7-e09f994b2862	2022-12-12	Warnings	Exact identifier unii: ETJ7Z6XBU4
Miranda Castros healing cell salts for bones, hair, nails and teeth Homeopathic Combination	CALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEA	OHM PHARMA INC.	044a7174-f7a3-490f-9cad-01f2665d7575	2022-12-02	Warnings	Exact identifier unii: ETJ7Z6XBU4
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Unichem Pharmaceuticals (USA), Inc.	35f26d3c-268b-4114-9b5b-1c2e0b9ddfd5	2022-11-22	Warnings, Adverse reactions	Exact identifier unii: WR978S7QHH
4 Kids Cold and Mucus Nighttime	EUPHRASIA STRICTA,SILICON DIOXIDE, RUMEX CRISPUS ROOT, ANEMONE PULSATILLA, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE AND SULFUR	Hyland's Inc.	6f7b2585-2f0e-5938-e053-2a91aa0aa9d1	2022-11-21	Warnings	Exact identifier unii: ETJ7Z6XBU4
4 Kids Complete Cold and Mucus	BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDE	Hyland's Inc.	ef39fe3d-a42d-4baa-9199-91f664feb432	2022-11-21	Warnings	Exact identifier unii: ETJ7Z6XBU4
UNDA 19	ALUMINIUM METALLICUM, DROSERA, ILLICIUM VERUM, MENTHA PIPERITA, SENEGA OFFICINALIS	Seroyal USA	4c47f5cd-fcb3-3ecb-e054-00144ff8d46c	2022-11-09	Warnings	Exact identifier unii: V95R5KMY2B
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Ascend Laboratories, LLC	07e66554-bc85-4853-9f40-1249617630a9	2022-09-30	Warnings, Adverse reactions	Exact identifier unii: WR978S7QHH
Hendel Periodontal and Tooth Pain Relief	SODIUM BORATE, TRIBASIC CALCIUM PHOSPHATE, MERCURIUS SOLUBILIS, AND SILICON DIOXIDE	MediNatura Inc	f34e9f77-69fd-4c7f-9eea-2d721a4d27fb	2022-08-22	Warnings	Exact identifier unii: ETJ7Z6XBU4
Rizatriptan	RIZATRIPTAN	Macleods Pharmaceuticals Limited	27bc2cfc-fefb-4b50-a0dc-6268c69b4902	2022-07-01	Warnings, Adverse reactions	Exact identifier unii: WR978S7QHH
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Proficient Rx LP	4a5b43f6-a5ea-4d6f-941f-3c19f242c896	2022-05-01	Warnings, Adverse reactions	Exact identifier unii: WR978S7QHH
ALPHA SH	SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS	Schwabe Mexico, S.A. de C.V.	3e2e5f52-db54-4635-83a8-a67a683c093c	2022-03-22	Warnings	Exact identifier unii: ETJ7Z6XBU4
ALPHA SH	SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS	Schwabe North America, Inc.	94de9ce3-6ee9-4322-bda2-0b4391f09d87	2022-03-22	Warnings	Exact identifier unii: ETJ7Z6XBU4
Ear Care	ECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUM	Newton Laboratories, Inc.	da807eb3-34a3-61b9-e053-2995a90a0e21	2022-03-18	Warnings	Exact identifier unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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