Saline Enema

Product NDC: 50382-002
11-digit product format: 503820002
Labeler code: 50382
Product ID: 50382-002_43a17fc1-50a5-4be9-85d2-b0d7ed36be2b
Type: HUMAN OTC DRUG
Nonproprietary name: SALINE ENEMA
Dosage form: ENEMA
Route: RECTAL
Labeler: Galentic Pharma (India) Priva Te Ltd.
Application: part334
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2013-08-01
Marketing end: 0000-00-00
Substance: SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC
Active strength: 7 g/118mL; g/118mL
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
efd58dcf-540a-4531-8766-e713129ca6f2	Product name	1	20250307
4b7700e3-6e0e-45e5-9d22-6f754d61386e	Product name	2	20250304
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50382-002-01	2019-11-27	C162847	48780-1	9855d018-d358-cd31-e053-dbdaa90ab51a	Enema, Saline

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50382-002-01	Saline Enema	118 mL in 1 BOTTLE	ENEMA	118		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
SODIUM PHOSPHATE, DIBASIC	ACTIVE INGREDIENT	GR686LBA74	SALINE ENEMA ENEMA [GALENTIC PHARMA (INDIA) PRIVA TE LTD.]	2
SODIUM PHOSPHATE, MONOBASIC	ACTIVE INGREDIENT	3980JIH2SW	SALINE ENEMA ENEMA [GALENTIC PHARMA (INDIA) PRIVA TE LTD.]	2
PHOSPHATE ION	ACTIVE MOIETY	NK08V8K8HR	SALINE ENEMA ENEMA [GALENTIC PHARMA (INDIA) PRIVA TE LTD.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	SALINE ENEMA ENEMA [GALENTIC PHARMA (INDIA) PRIVA TE LTD.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50382-002	SALINE ENEMA ENEMA [GALENTIC PHARMA (INDIA) PRIVA TE LTD.]	2	Legacy NDC, 1 package rows	20130808_619f934e-ac71-4447-a17b-1a30d1073b36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
283100	sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM in 118 ML Enema	PSN	619f934e-ac71-4447-a17b-1a30d1073b36	2
283100	sodium phosphate, dibasic 59.3 MG/ML / sodium phosphate, monobasic 161 MG/ML Enema	SCD	619f934e-ac71-4447-a17b-1a30d1073b36	2
283100	sodium phosphate, dibasic 3.5 GM / sodium phosphate, monobasic 9.5 GM per 59 ML Enema	SY	619f934e-ac71-4447-a17b-1a30d1073b36	2
283100	sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM per 118 ML Enema	SY	619f934e-ac71-4447-a17b-1a30d1073b36	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
50382-002-01	50382000201	118 mL in 1 BOTTLE	118 ml	Historical