Ethambutol Hydrochloride

Product NDC
61748-014
11-digit product format
617480014
Labeler code
61748
Product ID
61748-014_ec79c565-d8aa-4833-9e73-2dd058f96546
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ethambutol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Versapharm Incorporated
Application
ANDA075095
Marketing category
ANDA
Marketing start
2015-03-18
Marketing end
0000-00-00
Substance
ETHAMBUTOL HYDROCHLORIDE
Active strength
400 mg/1
Pharmacologic classes
Antimycobacterial [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e86e15b7-896a-6fb4-16e3-cf6efd994b64Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61748-014-01EA - Each61748-01473d2374b-3acc-44ea-aafc-9f88add43a8c12012-07-24
61748-014-06EA - Each61748-0140f775670-d957-412f-a882-76674d0555d312012-07-24
61748-014-09EA - Each61748-014551e6bad-ac17-4a6b-a942-8e204c768cd812012-07-24
61748-014-10EA - Each61748-0144a2bfc7a-ecad-45fd-85cc-5db1f97492df12012-07-24
61748-014-11EA - Each61748-0149dc00e20-2841-4331-ac54-319b10d43f8912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHAMBUTOL HYDROCHLORIDEACTIVE INGREDIENTQE4VW5FO07ETHAMBUTOL (ETHAMBUTOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
ETHAMBUTOLACTIVE MOIETY8G167061QZETHAMBUTOL (ETHAMBUTOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ETHAMBUTOL (ETHAMBUTOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ETHAMBUTOL (ETHAMBUTOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSE 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2ETHAMBUTOL (ETHAMBUTOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XETHAMBUTOL (ETHAMBUTOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ETHAMBUTOL (ETHAMBUTOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AETHAMBUTOL (ETHAMBUTOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HETHAMBUTOL (ETHAMBUTOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
POVIDONE K30INACTIVE INGREDIENTU725QWY32XETHAMBUTOL (ETHAMBUTOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
RAW SUGARINACTIVE INGREDIENT8M707QY5GHETHAMBUTOL (ETHAMBUTOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ETHAMBUTOL (ETHAMBUTOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJETHAMBUTOL (ETHAMBUTOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APETHAMBUTOL (ETHAMBUTOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPETHAMBUTOL (ETHAMBUTOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995607ethambutol HCl 400 MG Oral TabletPSNb48756dd-582d-4e4f-9b65-70a797c8ac6a4
995607ethambutol hydrochloride 400 MG Oral TabletSCDb48756dd-582d-4e4f-9b65-70a797c8ac6a4
995607ethambutol HCl 400 MG Oral TabletPSNb2f95b0b-9de3-4c0b-a46e-a7eee6428b4b3
995607ethambutol hydrochloride 400 MG Oral TabletSCDb2f95b0b-9de3-4c0b-a46e-a7eee6428b4b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61748-014-0161748001401100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61748-014-01) 2015-03-180000-00-00NoNoCurrent
61748-014-066174800140660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61748-014-06) 2015-03-180000-00-00NoNoCurrent
61748-014-096174800140990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61748-014-09) 2015-03-180000-00-00NoNoCurrent
61748-014-10617480014101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61748-014-10) 2015-03-180000-00-00NoNoCurrent
61748-014-116174800141110 BLISTER PACK in 1 CARTON (61748-014-11) > 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2015-03-180000-00-00NoNoCurrent