Hydrocodone Bitartrate and Acetaminophen

Product NDC
10702-193
11-digit product format
107020193
Labeler code
10702
Product ID
10702-193_4a169a07-a8cd-ada4-e063-6394a90ac7d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
KVK-Tech, Inc.
Application
ANDA209036
Marketing category
ANDA
Marketing start
2017-06-22
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
300; 7.5 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A209036-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE300MG;5MGTABLET / ORALAA2017-06-21
A209036-002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE300MG;7.5MGTABLET / ORALAA2017-06-21
A209036-003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE300MG;10MGTABLET / ORALAA2017-06-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209036-001AA
A209036-002AA
A209036-003AA

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.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A209036-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2017-06-21caaa826d4ba7…
2026-08-18 06:07:402026-07A209036-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2017-06-21caaa826d4ba7…
2026-08-18 06:07:402026-07A209036-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2017-06-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209036-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2017-06-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209036-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2017-06-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209036-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2017-06-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209036-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2017-06-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209036-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2017-06-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209036-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2017-06-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209036-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2017-06-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209036-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2017-06-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209036-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2017-06-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209036-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2017-06-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209036-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2017-06-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209036-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2017-06-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209036-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2017-06-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209036-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2017-06-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209036-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2017-06-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209036-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2017-06-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209036-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2017-06-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209036-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2017-06-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209036-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2017-06-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209036-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2017-06-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209036-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2017-06-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209036-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2017-06-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209036-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2017-06-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209036-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2017-06-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209036-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2017-06-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209036-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2017-06-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209036-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2017-06-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209036-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2017-06-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A209036-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2017-06-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A209036-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2017-06-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209036-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2017-06-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209036-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2017-06-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209036-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2017-06-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209036-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2017-06-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209036-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2017-06-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209036-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2017-06-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209036-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2017-06-211e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A209036-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A209036-002AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A209036-003AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209036-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209036-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209036-003AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209036-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209036-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209036-003AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209036-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209036-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209036-003AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209036-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209036-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209036-003AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209036-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209036-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209036-003AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209036-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209036-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209036-003AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209036-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209036-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209036-003AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209036-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209036-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209036-003AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209036-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209036-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209036-003AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209036-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209036-002AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209036-003AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209036-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209036-002AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209036-003AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209036-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209036-002AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209036-003AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209036-001AA11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrocodone Bitartrate and Acetaminophen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCODONE BITARTRATE300 mg/1
ACETAMINOPHEN7.5 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 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
856980Internal RxNorm lookup
856987Internal RxNorm lookup
856992Internal RxNorm lookup
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
f1063950-b302-4898-81c2-b1626c9c16efAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
53523715-c529-4d52-b9ff-1e5d76636f53Product name220210818
31b11e56-5b35-4ab6-a3a8-f0b48973dcedProduct name220200611
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
7855f8e3-562e-4273-8b79-0059c07a71f7Product name120170901
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
a5244f9c-cd67-0e27-d63b-65fd7e584400Product name220170504
b654f2d9-ebeb-451d-96ee-22f583344623Product name120170424
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10702-193-01Hydrocodone Bitartrate and Acetaminophen100 in 1 BOTTLETABLET10017
10702-193-03Hydrocodone Bitartrate and Acetaminophen30 in 1 BOTTLETABLET3017
10702-193-10Hydrocodone Bitartrate and Acetaminophen1000 in 1 BOTTLETABLET100017
10702-193-50Hydrocodone Bitartrate and Acetaminophen500 in 1 BOTTLETABLET50017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10702-193-01EA - Each10702-193f887ae83-5550-4e93-814a-ce85a650696312018-05-09
10702-193-50EA - Each10702-193d7b11317-d638-47c2-9b8e-b52d48eb872112017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-193HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KVK-TECH, INC.]16Current NDC, Legacy NDC, 4 package rows20240118_f1063950-b302-4898-81c2-b1626c9c16ef.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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 ACETAMINOPHENKVK-Tech, Inc.f1063950-b302-4898-81c2-b1626c9c16ef2026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209036
application number: ANDA209036
ndc (product): 10702-193

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856980HYDROcodone bitartrate 10 MG / acetaminophen 300 MG Oral TabletPSNf1063950-b302-4898-81c2-b1626c9c16ef17
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSNf1063950-b302-4898-81c2-b1626c9c16ef17
856987HYDROcodone bitartrate 5 MG / acetaminophen 300 MG Oral TabletPSNf1063950-b302-4898-81c2-b1626c9c16ef17
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSNf1063950-b302-4898-81c2-b1626c9c16ef17
856992HYDROcodone bitartrate 7.5 MG / acetaminophen 300 MG Oral TabletPSNf1063950-b302-4898-81c2-b1626c9c16ef17
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSNf1063950-b302-4898-81c2-b1626c9c16ef17
856980acetaminophen 300 MG / hydrocodone bitartrate 10 MG Oral TabletSCDf1063950-b302-4898-81c2-b1626c9c16ef17
856987acetaminophen 300 MG / hydrocodone bitartrate 5 MG Oral TabletSCDf1063950-b302-4898-81c2-b1626c9c16ef17
856992acetaminophen 300 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCDf1063950-b302-4898-81c2-b1626c9c16ef17
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCDf1063950-b302-4898-81c2-b1626c9c16ef17
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCDf1063950-b302-4898-81c2-b1626c9c16ef17
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCDf1063950-b302-4898-81c2-b1626c9c16ef17
856980APAP 300 MG / hydrocodone bitartrate 10 MG Oral TabletSYf1063950-b302-4898-81c2-b1626c9c16ef17
856987APAP 300 MG / hydrocodone bitartrate 5 MG Oral TabletSYf1063950-b302-4898-81c2-b1626c9c16ef17
856992APAP 300 MG / Hydrocodone Bitartrate 7.5 MG Oral TabletSYf1063950-b302-4898-81c2-b1626c9c16ef17
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSYf1063950-b302-4898-81c2-b1626c9c16ef17
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSYf1063950-b302-4898-81c2-b1626c9c16ef17
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSYf1063950-b302-4898-81c2-b1626c9c16ef17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10702-193-0110702019301100 TABLET in 1 BOTTLE (10702-193-01) 100 tablet2017-06-220000-00-00NoNoCurrent
10702-193-031070201930330 TABLET in 1 BOTTLE (10702-193-03) 30 tablet2017-06-220000-00-00NoNoCurrent
10702-193-10107020193101000 TABLET in 1 BOTTLE (10702-193-10) 1000 tablet2017-06-220000-00-00NoNoCurrent
10702-193-5010702019350500 TABLET in 1 BOTTLE (10702-193-50) 500 tablet2017-06-220000-00-00NoNoCurrent