FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
42806-113
11-digit product format
428060113
Labeler code
42806
Product ID
42806-113_b3500a38-9dd0-4950-94f5-337c8f064e94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA203863
Marketing category
ANDA
Marketing start
2018-04-02
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325; 10 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203863-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;5MGTABLET / ORALAA2018-03-30
A203863-002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;7.5MGTABLET / ORALAA2018-03-30
A203863-003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;10MGTABLET / ORALAA2018-03-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A203863-001AA
A203863-002AA
A203863-003AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A203863-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-03-30a50c72e98297…
2026-08-01 22:54:322026-06A203863-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-03-30a50c72e98297…
2026-08-01 22:54:322026-06A203863-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-03-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A203863-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A203863-002AA1a50c72e98297…
2026-08-01 22:54:322026-06A203863-003AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENEpic Pharma, LLC5179d4ab-6d57-4613-84fc-de3f6edd6a532025-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203863
application number: ANDA203863
ndc (product): 42806-113

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrocodone Bitartrate and Acetaminophen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
HYDROCODONE BITARTRATE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
NO70W886KKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
856999Internal RxNorm lookup
857002Internal RxNorm lookup
857005Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5179d4ab-6d57-4613-84fc-de3f6edd6a53Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
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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
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41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
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53523715-c529-4d52-b9ff-1e5d76636f53Product name220210818
31b11e56-5b35-4ab6-a3a8-f0b48973dcedProduct name220200611
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20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
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22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
7855f8e3-562e-4273-8b79-0059c07a71f7Product name120170901
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332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
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cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
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d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42806-113-01Hydrocodone Bitartrate and Acetaminophen100 in 1 BOTTLETABLET10021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-113-01EA - Each42806-1130152919b-a5b0-40a5-b3a9-051b8ab76bdb12018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-113HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [EPIC PHARMA, LLC]19Current NDC, Legacy NDC, 1 package rows20241222_5179d4ab-6d57-4613-84fc-de3f6edd6a53.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN5179d4ab-6d57-4613-84fc-de3f6edd6a5321
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN5179d4ab-6d57-4613-84fc-de3f6edd6a5321
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSN5179d4ab-6d57-4613-84fc-de3f6edd6a5321
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD5179d4ab-6d57-4613-84fc-de3f6edd6a5321
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD5179d4ab-6d57-4613-84fc-de3f6edd6a5321
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCD5179d4ab-6d57-4613-84fc-de3f6edd6a5321
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY5179d4ab-6d57-4613-84fc-de3f6edd6a5321
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY5179d4ab-6d57-4613-84fc-de3f6edd6a5321
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSY5179d4ab-6d57-4613-84fc-de3f6edd6a5321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-113-0142806011301100 TABLET in 1 BOTTLE (42806-113-01) 100 tablet2018-04-020000-00-00NoNoCurrent