Erythrocin Stearate

Product NDC
10544-594
11-digit product format
105440594
Labeler code
10544
Product ID
10544-594_3106c828-9c18-4530-89ae-b1c99ab6aa22
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin Stearate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA060359
Marketing category
ANDA
Marketing start
2010-03-09
Marketing end
0000-00-00
Substance
ERYTHROMYCIN STEARATE
Active strength
250 mg/1
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [CS]
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 conceptRelationVersionEffective
d329c2e1-5ae8-4e64-aea0-77ecea3fa1abProduct name320250717
3b331500-3b74-bd2b-fede-d46839f2f4d5Product name620240313
fdae2630-eae0-4769-abfd-8f33d5b771b4Product name320240202
8c898317-b543-1e4e-254f-84cec2f3f57eProduct name220191002
64ae94c0-3212-d73a-92da-9e6dd85c6ebeProduct name220180118
edcfa1cf-915f-1a4c-d0aa-508cc66e70d9Product name220170816
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
57850177-5927-151f-e1fa-7e2ca47f81e5Product name120140508
8ee71591-1d8f-e24e-242b-bfef131e3168Product name120140508
bff5cf99-0f45-fa15-2a76-b160c3c4cc3cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-594-28Erythrocin Stearate28 in 1 BOTTLETABLET, FILM COATED283
10544-594-40Erythrocin Stearate40 in 1 BOTTLETABLET, FILM COATED403

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-594-28EA - Each10544-594a2c8c4a4-d503-4d43-8c8a-8c9026b3afe512015-10-02
10544-594-40EA - Each10544-5944f776fc2-06ab-4871-a557-73b3c0027d6712015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ERYTHROMYCIN STEARATEACTIVE INGREDIENTLXW024X05MERYTHROCIN STEARATE (ERYTHROMYCIN STEARATE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
ERYTHROMYCINACTIVE MOIETY63937KV33DERYTHROCIN STEARATE (ERYTHROMYCIN STEARATE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311ERYTHROCIN STEARATE (ERYTHROMYCIN STEARATE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8ERYTHROCIN STEARATE (ERYTHROMYCIN STEARATE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYERYTHROCIN STEARATE (ERYTHROMYCIN STEARATE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
MAGNESIUM HYDROXIDEINACTIVE INGREDIENTNBZ3QY004SERYTHROCIN STEARATE (ERYTHROMYCIN STEARATE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUERYTHROCIN STEARATE (ERYTHROMYCIN STEARATE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AERYTHROCIN STEARATE (ERYTHROMYCIN STEARATE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EERYTHROCIN STEARATE (ERYTHROMYCIN STEARATE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ERYTHROCIN STEARATE (ERYTHROMYCIN STEARATE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRERYTHROCIN STEARATE (ERYTHROMYCIN STEARATE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BERYTHROCIN STEARATE (ERYTHROMYCIN STEARATE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD56ERYTHROCIN STEARATE (ERYTHROMYCIN STEARATE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJERYTHROCIN STEARATE (ERYTHROMYCIN STEARATE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPERYTHROCIN STEARATE (ERYTHROMYCIN STEARATE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
VANILLININACTIVE INGREDIENTCHI530446XERYTHROCIN STEARATE (ERYTHROMYCIN STEARATE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-594ERYTHROCIN STEARATE (ERYTHROMYCIN STEARATE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3Legacy NDC, 2 package rows20150801_8aa50166-8f4f-4389-8354-c558c20e63b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
750839Erythrocin Stearate 250 MG Oral TabletPSN8aa50166-8f4f-4389-8354-c558c20e63b63
750841Erythrocin Stearate 500 MG Oral TabletPSN8aa50166-8f4f-4389-8354-c558c20e63b63
686355erythromycin stearate 250 MG Oral TabletPSN8aa50166-8f4f-4389-8354-c558c20e63b63
686406erythromycin stearate 500 MG Oral TabletPSN8aa50166-8f4f-4389-8354-c558c20e63b63
750839erythromycin stearate 250 MG Oral Tablet [Erythrocin Stearate]SBD8aa50166-8f4f-4389-8354-c558c20e63b63
750841erythromycin stearate 500 MG Oral Tablet [Erythrocin Stearate]SBD8aa50166-8f4f-4389-8354-c558c20e63b63
686355erythromycin stearate 250 MG Oral TabletSCD8aa50166-8f4f-4389-8354-c558c20e63b63
686406erythromycin stearate 500 MG Oral TabletSCD8aa50166-8f4f-4389-8354-c558c20e63b63
750839Erythrocin Stearate 250 MG Oral TabletSY8aa50166-8f4f-4389-8354-c558c20e63b63
750841Erythrocin Stearate 500 MG Oral TabletSY8aa50166-8f4f-4389-8354-c558c20e63b63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-594-281054405942828 in 1 BOTTLEHistorical
10544-594-401054405944040 in 1 BOTTLEHistorical