FDA.reportPublic FDA data

hydrocodone bitartrate and acetaminophen

Product NDC
63629-1180
Requested package NDC
63629-1180-1
11-digit product format
636291180
Labeler code
63629
Product ID
63629-1180_dded5cf1-e979-404c-b2b0-5b6544e20e6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrocodone bitartrate and acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207509
Marketing category
ANDA
Marketing start
2019-06-17
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-118063629-1180-1DDiscontinued by firm2026-07-31

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
A207509-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE300MG;5MGTABLET / ORALAA2018-10-29
A207509-002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE300MG;7.5MGTABLET / ORALAA2018-10-29
A207509-003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE300MG;10MGTABLET / ORALAA2018-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207509-001AA
A207509-002AA
A207509-003AA

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 22:54:322026-06A207509-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2018-10-29a50c72e98297…
2026-08-01 22:54:322026-06A207509-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2018-10-29a50c72e98297…
2026-08-01 22:54:322026-06A207509-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2018-10-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A207509-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A207509-002AA1a50c72e98297…
2026-08-01 22:54:322026-06A207509-003AA1a50c72e98297…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hydrocodone bitartrate and acetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack1170f2f0-f087-4b68-afb5-7c049cb9a6192026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207509
application number: ANDA207509
hydrocodone bitartrate and acetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackafdc6256-f7d0-404b-a377-328250ab29ff2026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207509
application number: ANDA207509
hydrocodone bitartrate and acetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack68c97e24-6898-4c17-813b-e1e62f56cb652026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207509
application number: ANDA207509
hydrocodone bitartrate and acetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack2f6d0712-e756-49f2-a6b8-bbd160a454c42026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207509
application number: ANDA207509
hydrocodone bitartrate and acetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackc648e299-2a8b-4530-a061-c6fd9cd1294c2026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207509
application number: ANDA207509
hydrocodone bitartrate and acetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackf08ea7a7-211e-4e0b-88c3-8f29a567fdc02026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207509
application number: ANDA207509
ndc (package): 63629-1180-1
ndc (product): 63629-1180
ndc11 (package): 63629118001
hydrocodone bitartrate and acetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack1cdeaf5e-5f82-4820-b244-b0ec7a7307e12026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207509
application number: ANDA207509
hydrocodone bitartrate and acetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENEywa Pharma Inc8a201e19-3e47-7e58-e053-2995a90ab1d52026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207509
application number: ANDA207509

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
NO70W886KKInternal UNII lookup
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
f08ea7a7-211e-4e0b-88c3-8f29a567fdc0Available 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
63629-1180-1hydrocodone bitartrate and acetaminophen100 in 1 BOTTLETABLET100102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1180HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 1 package rows20240110_f08ea7a7-211e-4e0b-88c3-8f29a567fdc0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856992HYDROcodone bitartrate 7.5 MG / acetaminophen 300 MG Oral TabletPSNf08ea7a7-211e-4e0b-88c3-8f29a567fdc0102
856992acetaminophen 300 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCDf08ea7a7-211e-4e0b-88c3-8f29a567fdc0102
856992APAP 300 MG / Hydrocodone Bitartrate 7.5 MG Oral TabletSYf08ea7a7-211e-4e0b-88c3-8f29a567fdc0102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1180-163629118001100 TABLET in 1 BOTTLE (63629-1180-1) 100 tablet2022-11-090000-00-00NoNoCurrent