Lortab

Product NDC
17856-0450
11-digit product format
178560450
Labeler code
17856
Product ID
17856-0450_d6b9770a-ae60-43d7-a611-ab627652d970
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
SYRUP
Route
ORAL
Labeler
Atlantic Biologicals Corps
Application
ANDA040881
Marketing category
ANDA
Marketing start
2015-03-17
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
10 mg/15mL; mg/15mL
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
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06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
53523715-c529-4d52-b9ff-1e5d76636f53Product name220210818
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
31b11e56-5b35-4ab6-a3a8-f0b48973dcedProduct name220200611
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
7855f8e3-562e-4273-8b79-0059c07a71f7Product name120170901
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
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d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
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47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
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7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
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b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0450-12020-01-31C16284748780-19d75b9d0-6d7b-f424-e053-dadaa90a57ce34fddb2d-ccc5-4189-ac2a-146b46c447f6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0450-1Lortab15 mL in 1 CUP, UNIT-DOSESYRUP152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0450LORTAB (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) SYRUP [ATLANTIC BIOLOGICALS CORPS]2Legacy NDC, 1 package rows20160629_34fddb2d-ccc5-4189-ac2a-146b46c447f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1044427HYDROcodone bitartrate 10 MG / acetaminophen 300 MG in 15 mL Oral SolutionPSN34fddb2d-ccc5-4189-ac2a-146b46c447f62
1442445LORTAB 10 MG / 300 MG in 15 mL Oral SolutionPSN34fddb2d-ccc5-4189-ac2a-146b46c447f62
1442445acetaminophen 20 MG/ML / hydrocodone bitartrate 0.667 MG/ML Oral Solution [Lortab]SBD34fddb2d-ccc5-4189-ac2a-146b46c447f62
1044427acetaminophen 20 MG/ML / hydrocodone bitartrate 0.667 MG/ML Oral SolutionSCD34fddb2d-ccc5-4189-ac2a-146b46c447f62
1044427APAP 20 MG/ML / Hydrocodone Bitartrate 0.667 MG/ML Oral SolutionSY34fddb2d-ccc5-4189-ac2a-146b46c447f62
1442445APAP 20 MG/ML / Hydrocodone Bitartrate 0.667 MG/ML Oral Solution [Lortab]SY34fddb2d-ccc5-4189-ac2a-146b46c447f62
1044427APAP 300 MG / hydrocodone bitartrate 10 MG per 15 ML Oral SolutionSY34fddb2d-ccc5-4189-ac2a-146b46c447f62
1442445Lortab (acetaminophen 300 MG / hydrocodone bitartrate 10 MG) per 15 ML Oral SolutionSY34fddb2d-ccc5-4189-ac2a-146b46c447f62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
17856-0450-11785604500115 mL in 1 CUP, UNIT-DOSE15 mlHistorical