FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
0406-0378
Requested package NDC
0406-0378-62
11-digit product format
004060378
Labeler code
0406
Product ID
0406-0378_84925071-325f-4e10-a767-378cbed0e59c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
SpecGx LLC
Application
ANDA206718
Marketing category
ANDA
Marketing start
2017-03-31
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
10; 300 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0406-03780406-0378-62DDiscontinued by firm2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A206718-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE300MG;5MGTABLET / ORALAARS2017-03-31
A206718-002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE300MG;7.5MGTABLET / ORALAARS2017-03-31
A206718-003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE300MG;10MGTABLET / ORALAARS2017-03-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206718-001AA
A206718-002AA
A206718-003AA

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A206718-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAARS2017-03-3184e616aacf4f…
2026-09-14 22:38:342026-08A206718-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAARS2017-03-3184e616aacf4f…
2026-09-14 22:38:342026-08A206718-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAARS2017-03-3184e616aacf4f…
2026-08-18 06:07:402026-07A206718-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAARS2017-03-31caaa826d4ba7…
2026-08-18 06:07:402026-07A206718-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAARS2017-03-31caaa826d4ba7…
2026-08-18 06:07:402026-07A206718-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAARS2017-03-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206718-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAARS2017-03-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206718-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAARS2017-03-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206718-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAARS2017-03-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206718-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAARS2017-03-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206718-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAARS2017-03-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206718-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAARS2017-03-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206718-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAARS2017-03-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206718-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAARS2017-03-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206718-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAARS2017-03-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206718-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAARS2017-03-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206718-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAARS2017-03-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206718-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAARS2017-03-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206718-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2017-03-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206718-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2017-03-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206718-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2017-03-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206718-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2017-03-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206718-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2017-03-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206718-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2017-03-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206718-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2017-03-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206718-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2017-03-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206718-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2017-03-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206718-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2017-03-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206718-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2017-03-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206718-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2017-03-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206718-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2017-03-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206718-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2017-03-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206718-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2017-03-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206718-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2017-03-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A206718-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2017-03-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A206718-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2017-03-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206718-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2017-03-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206718-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2017-03-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206718-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2017-03-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206718-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2017-03-31301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A206718-001AA184e616aacf4f…
2026-09-14 22:38:342026-08A206718-002AA184e616aacf4f…
2026-09-14 22:38:342026-08A206718-003AA184e616aacf4f…
2026-08-18 06:07:402026-07A206718-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A206718-002AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A206718-003AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206718-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206718-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206718-003AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206718-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206718-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206718-003AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206718-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206718-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206718-003AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206718-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206718-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206718-003AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206718-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206718-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206718-003AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206718-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206718-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206718-003AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206718-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206718-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206718-003AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206718-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206718-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206718-003AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206718-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206718-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206718-003AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206718-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206718-002AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206718-003AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206718-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206718-002AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206718-003AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206718-001AA1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 BITARTRATE10 mg/1
ACETAMINOPHEN300 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
856980Internal RxNorm lookup
856987Internal RxNorm lookup
856992Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d621b526-4d9a-48a9-9a3e-d29d6aea2f31Available 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
0406-0378-01Hydrocodone Bitartrate and Acetaminophen100 in 1 BOTTLETABLET10024
0406-0378-05Hydrocodone Bitartrate and Acetaminophen500 in 1 BOTTLETABLET50024
0406-0378-23Hydrocodone Bitartrate and Acetaminophen1 in 1 BLISTER PACKTABLET124
0406-0378-62Hydrocodone Bitartrate and Acetaminophen10 in 1 BLISTER PACKTABLET1024
0406-0378-62Hydrocodone Bitartrate and Acetaminophen10 in 1 CARTONTABLET1024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-0378-01EA - Each0406-03782d086f06-65f4-49e7-9cf0-11bf89531e3b12017-05-03
0406-0378-05EA - Each0406-037889cfee16-f181-4f57-89ec-3ddda628c39612017-05-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-0378HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [SPECGX LLC]22Current NDC, Legacy NDC, 5 package rows20240224_d621b526-4d9a-48a9-9a3e-d29d6aea2f31.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 ACETAMINOPHENSpecGx LLCd621b526-4d9a-48a9-9a3e-d29d6aea2f312026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206718
application number: ANDA206718
ndc (package): 0406-0378-62
ndc (product): 0406-0378
ndc11 (package): 00406037862

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856980HYDROcodone bitartrate 10 MG / acetaminophen 300 MG Oral TabletPSNd621b526-4d9a-48a9-9a3e-d29d6aea2f3124
856987HYDROcodone bitartrate 5 MG / acetaminophen 300 MG Oral TabletPSNd621b526-4d9a-48a9-9a3e-d29d6aea2f3124
856992HYDROcodone bitartrate 7.5 MG / acetaminophen 300 MG Oral TabletPSNd621b526-4d9a-48a9-9a3e-d29d6aea2f3124
856980acetaminophen 300 MG / hydrocodone bitartrate 10 MG Oral TabletSCDd621b526-4d9a-48a9-9a3e-d29d6aea2f3124
856987acetaminophen 300 MG / hydrocodone bitartrate 5 MG Oral TabletSCDd621b526-4d9a-48a9-9a3e-d29d6aea2f3124
856992acetaminophen 300 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCDd621b526-4d9a-48a9-9a3e-d29d6aea2f3124
856980APAP 300 MG / hydrocodone bitartrate 10 MG Oral TabletSYd621b526-4d9a-48a9-9a3e-d29d6aea2f3124
856987APAP 300 MG / hydrocodone bitartrate 5 MG Oral TabletSYd621b526-4d9a-48a9-9a3e-d29d6aea2f3124
856992APAP 300 MG / Hydrocodone Bitartrate 7.5 MG Oral TabletSYd621b526-4d9a-48a9-9a3e-d29d6aea2f3124

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0406-0378-620040603786210 BLISTER PACK in 1 CARTON (0406-0378-62) > 10 TABLET in 1 BLISTER PACK10 blister pack2017-03-310000-00-00NoNoCurrent