NDC 55553-449 - ACL5SPG SINGLE SHOT EPIDURAL

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: 55553-449
Package NDCs from labels: 55553-449-02
Manufacturer: Clint Pharmaceuticals, Inc. | Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc. | Kwang Myung Pharm. Co., Ltd.
Effective date: 2013-02-12
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
ACL5SPG SINGLE SHOT EPIDURAL	Clint Pharmaceuticals, Inc. \| Smiths Medical ASD, Inc. \| Hospira, Inc. \| Aplicare, Inc. \| Kwang Myung Pharm. Co., Ltd.	2013-02-12	MEDICAL DEVICE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0409-4713-65	ACL5SPG SINGLE SHOT EPIDURAL	5 mL in 1 AMPULE	INJECTION, SOLUTION	5 mL	10 mg in 1mL	2
55553-449-02	ACL5SPG SINGLE SHOT EPIDURAL	1 in 1 PACKAGE, COMBINATION	KIT	1		2
55553-449-02	ACL5SPG SINGLE SHOT EPIDURAL	30 in 1 CASE	KIT	30		2
65282-1510-1	ACL5SPG SINGLE SHOT EPIDURAL	10 mL in 1 AMPULE	SOLUTION	10 mL	9 mg in 1mL	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55553-449	ACL5SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]	2	4 package rows	20130220_51586daa-df26-4242-b970-c7d29fe30660.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LIDOCAINE HYDROCHLORIDE ANHYDROUS	ACTIVE INGREDIENT	EC2CNF7XFP	ACL5SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]	2
POVIDONE-IODINE	ACTIVE INGREDIENT	85H0HZU99M	ACL5SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]	2
SODIUM CHLORIDE	ACTIVE INGREDIENT	451W47IQ8X	ACL5SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]	2
CHLORIDE ION	ACTIVE MOIETY	Q32ZN48698	ACL5SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]	2
IODINE	ACTIVE MOIETY	9679TC07X4	ACL5SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]	2
Lidocaine	ACTIVE MOIETY	98PI200987	ACL5SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ACL5SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]	2
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	ACL5SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]	2
NONOXYNOL-9	INACTIVE INGREDIENT	48Q180SH9T	ACL5SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]	2
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	ACL5SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ACL5SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]	2
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	ACL5SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	ACL5SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]	2

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 71 of 71 · 1,417 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Homeoplex B	ARSENICUM ALBUM, CALCAREA CARBONICA , IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA, STAPHYSAGRIA	Supplement Clinic, LLC.	e9a9c58e-1b70-4ac8-9d9c-108c628d7664	2017-10-31	Warnings	Exact identifier unii: 451W47IQ8X
Spleen-Pro T018	SPLEEN (SUIS), ARSENICUM ALBUM, CARBO VEGETABILIS, CEANOTHUS AMERICANUS, CHININUM SULPHURICUM, IGNATIA AMARA, IODIUM, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, PHOSPHORUS	Guangzhou Renuma Medical Systems Co., Ltd	bc2b70bd-2a4a-46fb-b3d8-d69b61056b89	2017-10-26	Warnings	Exact identifier unii: 451W47IQ8X
Female Vitality T010	CIMICIFUGA RACEMOSA, FUCUS VESICULOSUS, OOPHORINUM (SUIS), HYPOPHYSIS SUIS, THYROIDINUM (SUIS), GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), SEPIA	Guangzhou Renuma Medical Systems Co., Ltd	694f0c36-b656-471a-9f38-2efb5193e05a	2017-10-20	Warnings	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	Baxter Healthcare Corporation	ef3e79c5-3f58-4b36-a296-64b7d9a651c1	2017-10-17	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
QUALITY CHOICE SINGLE SALINE LAXATIVE	SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	Alcyon Health, LLC.	eb499c7f-9c7b-4097-83a3-82aabffd6beb	2017-07-12	Warnings	Exact identifier unii: GR686LBA74
Pro-Enema Single Saline Laxative	SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	Propharma Medical Supplies	e53c5eda-21da-4aed-a592-315100167cc2	2017-06-08	Warnings	Exact identifier unii: GR686LBA74
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Company	886f889b-f3cf-4197-b307-6cfa88c89436	2017-05-04		Exact identifier unii: 451W47IQ8X
Saline Laxative Cherry Laxative	SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	Dolgencorp Inc.	ca3c00d9-4301-4de8-94f5-34f1bcc761ab	2017-04-13	Warnings	Exact identifier unii: GR686LBA74
Eye Wash	WATER	CVS Pharmacy	049cee29-7ec2-4d5b-8308-f522acde43a7	2017-03-29	Warnings	Exact identifier unii: 059QF0KO0R
ReHydration	ADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS (BOVINE), KALI PHOSPHORICUM, NATRUM MURIATICUM, SARSAPARILLA, SILICEA, TARAXACUM OFFICINALE, THYROIDINUM (BOVINE)	Energetix Corp	9883c502-9782-451e-9eec-c54d7b054f31	2017-01-31	Warnings	Exact identifier unii: 451W47IQ8X
Tox-Chord	ALFALFA, ALUMINA, BENZOICUM ACIDUM, CARBONEUM, CETRARIA ISLANDICA, FOLLICULINUM, FUCUS VESICULOSUS, FUMARICUM ACIDUM, HEPAR SUIS, KALI CARBONICUM, KREOSOTUM, NATRUM MURIATICUM, PARAFFINUM, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PIX LIQUIDA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PULSATILLA (VULGARIS), RADIUM BROMATUM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM OFFICINALE, TABACUM, TEREBINTHINA, THYROIDINUM (BOVINE), TRITICUM REPENS, ZINCUM OXYDATUM	Energetix Corp	6b0d1628-b20d-426e-9c84-5cceadca3f45	2016-11-11	Warnings	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	Baxter Healthcare Company	210dc9ab-d6ca-4552-ac19-1be17792d290	2016-05-31	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	2a96096d-43cc-49b7-af53-b53c17f41001	2014-07-25	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
SODIUM CHLORIDE	SODIUM CHLORIDE	Baxter Healthcare Corporation	b3b4b176-41f0-4ca8-90d4-3fba5707564a	2014-02-21		Exact identifier unii: 451W47IQ8X
TIS-U-SOL	SODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATE	Baxter Healthcare Corporation	9da4121f-d62d-4da4-8dfb-0494da16015f	2014-02-21		Exact identifier unii: 451W47IQ8X
Ringers	SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE,	Baxter Healthcare Corporation	e1953d54-818d-46a6-8532-518ebae6d84e	2012-06-13		Exact identifier unii: 451W47IQ8X
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Baxter Healthcare Corporation	f09f80bf-2f8b-4420-865d-aec2d5e5cd4d	2012-06-12		Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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