FDA.reportPublic FDA data

Bismuth Subsalicylate/Metronidazole/Tetracycline Hydrochloride

Product NDC
70556-103
11-digit product format
705560103
Labeler code
70556
Product ID
70556-103_0a416c16-2a51-4567-a9b5-01dff63230d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules
Dosage form
KIT
Labeler
Ailex Pharmaceuticals, LLC
Application
ANDA202584
Marketing category
ANDA
Marketing start
2018-11-30
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8ffb9b1d-3ed7-ba2e-677e-47d4d134fd55Product name520251024
7f6d14e0-4366-41bc-a4a9-b74c79a20e17Product name120250623
e6d321b0-0e5e-7da6-f043-92b6a91f00a1Product name520250515
e1aac33b-94ae-4ee9-905b-299f7263853bProduct name320250124
16642716-d28a-4f90-8dcb-3921cd8c8109Product name420240516
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
151122cd-8b80-4972-8b02-3a4dda642fbcProduct name220200701
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
a5070875-62bb-61e1-fd46-8f7054197a40Product name820180215
0add4de9-d152-3375-3390-1123dddc5e3dProduct name120140508
33ca0fcc-1011-92dc-50a9-a383683eed1eProduct name120140508
53f39d9f-cd3f-04e1-c668-d4580719d57dProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
a804000f-b74f-0b5d-d17b-aa767c286ddbProduct name120140508
a91ea265-6e02-c08f-93c8-686d54180529Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70556-103-142021-01-29C16284748780-1ba0f9c33-5306-a910-e053-dadaa90a0b85Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70556-103-14Bismuth Subsalicylate/Metronidazole/Tetracycline Hydrochloride4 in 1 BLISTER PACKKIT42
70556-103-14Bismuth Subsalicylate/Metronidazole/Tetracycline Hydrochloride14 in 1 CARTONKIT142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70556-103BISMUTH SUBSALICYLATE/METRONIDAZOLE/TETRACYCLINE HYDROCHLORIDE (BISMUTH SUBSALICYLATE CHEWABLE TABLETS/METRONIDAZOLE TABLETS/TETRACYCLINE HYDROCHLORIDE CAPSULES) KIT [AILEX PHARMACEUTICALS, LLC]2Legacy NDC, 2 package rows20191125_0c809fa5-c630-4bf1-a0fc-5ee875008807.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
758019{112 (bismuth subsalicylate 262 MG Chewable Tablet) / 56 (metronidazole 250 MG Oral Tablet) / 56 (tetracycline hydrochloride 500 MG Oral Capsule) } PackGPCK0c809fa5-c630-4bf1-a0fc-5ee8750088072
308761bismuth subsalicylate 262 MG Chewable TabletPSN0c809fa5-c630-4bf1-a0fc-5ee8750088072
758019bismuth subsalicylate 262 MG Chewable Tablet (112) / metroNIDAZOLE 250 MG Oral Tablet (56) / tetracycline HCl 500 MG Oral Capsule (56) PackPSN0c809fa5-c630-4bf1-a0fc-5ee8750088072
314106metroNIDAZOLE 250 MG Oral TabletPSN0c809fa5-c630-4bf1-a0fc-5ee8750088072
198252tetracycline HCl 500 MG Oral CapsulePSN0c809fa5-c630-4bf1-a0fc-5ee8750088072
308761bismuth subsalicylate 262 MG Chewable TabletSCD0c809fa5-c630-4bf1-a0fc-5ee8750088072
314106metronidazole 250 MG Oral TabletSCD0c809fa5-c630-4bf1-a0fc-5ee8750088072
198252tetracycline hydrochloride 500 MG Oral CapsuleSCD0c809fa5-c630-4bf1-a0fc-5ee8750088072
198252tetracycline (as tetracycline hydrochloride) 500 MG Oral CapsuleSY0c809fa5-c630-4bf1-a0fc-5ee8750088072
198252tetracycline HCl 500 MG Oral CapsuleSY0c809fa5-c630-4bf1-a0fc-5ee8750088072

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
70556-103-14705560103144 in 1 BLISTER PACKHistorical