FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
71335-9734
11-digit product format
713359734
Labeler code
71335
Product ID
71335-9734_368725ec-f1df-4f17-a2e0-3bd5d4cb89d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202214
Marketing category
ANDA
Marketing start
2014-10-06
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
5; 325 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 44.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202214-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;5MGTABLET / ORALAA2013-03-27
A202214-002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;7.5MGTABLET / ORALAA2013-03-27
A202214-003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;10MGTABLET / ORALAA2013-03-27
A202214-004HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE300MG;5MGTABLET / ORALAA2016-03-15
A202214-005HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE300MG;7.5MGTABLET / ORALAA2016-03-15
A202214-006HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE300MG;10MGTABLET / ORALAA2016-03-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A202214-001AA
A202214-002AA
A202214-003AA
A202214-004AA
A202214-005AA
A202214-006AA

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 7 · 264 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A202214-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-03-27c2088c7a36db…
2026-10-15 13:18:302026-09A202214-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-03-27c2088c7a36db…
2026-10-15 13:18:302026-09A202214-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-03-27c2088c7a36db…
2026-10-15 13:18:302026-09A202214-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2016-03-15c2088c7a36db…
2026-10-15 13:18:302026-09A202214-005HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2016-03-15c2088c7a36db…
2026-10-15 13:18:302026-09A202214-006HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2016-03-15c2088c7a36db…
2026-09-14 22:38:342026-08A202214-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A202214-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A202214-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A202214-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2016-03-1584e616aacf4f…
2026-09-14 22:38:342026-08A202214-005HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2016-03-1584e616aacf4f…
2026-09-14 22:38:342026-08A202214-006HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2016-03-1584e616aacf4f…
2026-08-18 06:07:402026-07A202214-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A202214-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A202214-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A202214-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2016-03-15caaa826d4ba7…
2026-08-18 06:07:402026-07A202214-005HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2016-03-15caaa826d4ba7…
2026-08-18 06:07:402026-07A202214-006HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2016-03-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202214-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202214-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202214-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202214-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2016-03-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202214-005HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2016-03-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202214-006HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2016-03-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202214-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202214-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202214-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202214-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2016-03-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202214-005HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2016-03-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202214-006HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2016-03-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A202214-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202214-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202214-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202214-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2016-03-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202214-005HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2016-03-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202214-006HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2016-03-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202214-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202214-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202214-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202214-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2016-03-15fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 264 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A202214-001AA1c2088c7a36db…
2026-10-15 13:18:302026-09A202214-002AA1c2088c7a36db…
2026-10-15 13:18:302026-09A202214-003AA1c2088c7a36db…
2026-10-15 13:18:302026-09A202214-004AA1c2088c7a36db…
2026-10-15 13:18:302026-09A202214-005AA1c2088c7a36db…
2026-10-15 13:18:302026-09A202214-006AA1c2088c7a36db…
2026-09-14 22:38:342026-08A202214-001AA184e616aacf4f…
2026-09-14 22:38:342026-08A202214-002AA184e616aacf4f…
2026-09-14 22:38:342026-08A202214-003AA184e616aacf4f…
2026-09-14 22:38:342026-08A202214-004AA184e616aacf4f…
2026-09-14 22:38:342026-08A202214-005AA184e616aacf4f…
2026-09-14 22:38:342026-08A202214-006AA184e616aacf4f…
2026-08-18 06:07:402026-07A202214-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A202214-002AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A202214-003AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A202214-004AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A202214-005AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A202214-006AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202214-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202214-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202214-003AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202214-004AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202214-005AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202214-006AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202214-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202214-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202214-003AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202214-004AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202214-005AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202214-006AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202214-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202214-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202214-003AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202214-004AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202214-005AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202214-006AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202214-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202214-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202214-003AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202214-004AA1fd3edfee7708…

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 BITARTRATE5 mg/1
ACETAMINOPHEN325 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
857002Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8e99994a-83b4-4b1f-9654-4ae373bf2c4dAvailable 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
71335-9734-0Hydrocodone Bitartrate and Acetaminophen10 in 1 BOTTLE, PLASTICTABLET10107
71335-9734-1Hydrocodone Bitartrate and Acetaminophen30 in 1 BOTTLE, PLASTICTABLET30107
71335-9734-2Hydrocodone Bitartrate and Acetaminophen120 in 1 BOTTLE, PLASTICTABLET120107
71335-9734-3Hydrocodone Bitartrate and Acetaminophen20 in 1 BOTTLE, PLASTICTABLET20107
71335-9734-4Hydrocodone Bitartrate and Acetaminophen60 in 1 BOTTLE, PLASTICTABLET60107
71335-9734-5Hydrocodone Bitartrate and Acetaminophen90 in 1 BOTTLE, PLASTICTABLET90107
71335-9734-6Hydrocodone Bitartrate and Acetaminophen50 in 1 BOTTLE, PLASTICTABLET50107
71335-9734-7Hydrocodone Bitartrate and Acetaminophen40 in 1 BOTTLE, PLASTICTABLET40107
71335-9734-8Hydrocodone Bitartrate and Acetaminophen15 in 1 BOTTLE, PLASTICTABLET15107
71335-9734-9Hydrocodone Bitartrate and Acetaminophen84 in 1 BOTTLE, PLASTICTABLET84107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-9734-0EA - Each71335-9734a4e95e78-09a3-484a-91a7-39ff5bb2ce9812023-10-16
71335-9734-1EA - Each71335-9734562ee014-21f4-47da-98e2-aebaf4245b1812023-10-16
71335-9734-2EA - Each71335-97348b41246c-a93d-43ca-bd7f-3515200992ba12023-10-16
71335-9734-3EA - Each71335-97345a4f1d20-d8ce-4f63-ad90-7107866f888b12023-10-16
71335-9734-4EA - Each71335-9734637cf5ae-e7bd-4ca2-9f62-29ee91a5c9cc12023-10-16
71335-9734-5EA - Each71335-973468bf4702-1705-42f8-9a66-8829b01d99c512023-10-16
71335-9734-7EA - Each71335-9734a5894328-8abf-42f2-868f-c647d0589b4612023-10-16
71335-9734-8EA - Each71335-9734a8ffca25-105a-4615-b434-76533eb0f89812023-10-16
71335-9734-9EA - Each71335-97340a6739fd-3117-49a5-8420-965318df63e912023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9734HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]106Current NDC, 10 package rows20240828_8e99994a-83b4-4b1f-9654-4ae373bf2c4d.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 2 of 2 · 33 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackab3646f2-1f09-4dec-9b4b-535ee9c0d3fe2025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackddb58213-79b7-466b-bac4-01fd2d410cba2025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack3aa038f9-f837-466f-aa3c-68a7bd0b23882025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepacka5f2b04d-d1ed-4070-9239-2fd3c36994cb2025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackc9f7f4c1-c4e2-4f9b-bb02-72fb35eb43252025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackb1e520d2-0347-4399-a765-fcacbc50f2882025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackde918a56-c43e-44c7-941c-f9dd581845a72025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack58f5603e-01c9-44f8-b947-3918fd14e0492025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack2ad2d00e-3796-4605-852f-a3d64d5ef09f2024-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENNuCare Pharmaceuticals, Inc.226765e9-a6b1-22b6-e063-6394a90a364e2024-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack9698729e-08d0-483c-b157-5a4061d970652024-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack6dde2f85-e329-4bca-832d-d45786df9f522024-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack6ad80616-b38d-4569-b24a-aa86e39feb662024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN8e99994a-83b4-4b1f-9654-4ae373bf2c4d107
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD8e99994a-83b4-4b1f-9654-4ae373bf2c4d107
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY8e99994a-83b4-4b1f-9654-4ae373bf2c4d107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9734-07133597340010 TABLET in 1 BOTTLE, PLASTIC (71335-9734-0) 10 tablet2023-06-08NoNoCurrent
71335-9734-17133597340130 TABLET in 1 BOTTLE, PLASTIC (71335-9734-1) 30 tablet2023-05-15NoNoCurrent
71335-9734-271335973402120 TABLET in 1 BOTTLE, PLASTIC (71335-9734-2) 120 tablet2023-05-30NoNoCurrent
71335-9734-37133597340320 TABLET in 1 BOTTLE, PLASTIC (71335-9734-3) 20 tablet2023-05-30NoNoCurrent
71335-9734-47133597340460 TABLET in 1 BOTTLE, PLASTIC (71335-9734-4) 60 tablet2023-06-02NoNoCurrent
71335-9734-57133597340590 TABLET in 1 BOTTLE, PLASTIC (71335-9734-5) 90 tablet2023-10-18NoNoCurrent
71335-9734-67133597340650 TABLET in 1 BOTTLE, PLASTIC (71335-9734-6) 50 tablet2026-04-09NoNoCurrent
71335-9734-77133597340740 TABLET in 1 BOTTLE, PLASTIC (71335-9734-7) 40 tablet2023-10-17NoNoCurrent
71335-9734-87133597340815 TABLET in 1 BOTTLE, PLASTIC (71335-9734-8) 15 tablet2023-05-30NoNoCurrent
71335-9734-97133597340984 TABLET in 1 BOTTLE, PLASTIC (71335-9734-9) 84 tablet2026-04-09NoNoCurrent