FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
63629-8885
11-digit product format
636298885
Labeler code
63629
Product ID
63629-8885_402e21dc-621c-4f4f-82bd-2ce6c1fe10af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210211
Marketing category
ANDA
Marketing start
2018-07-13
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325; 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 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
A210211-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;5MGTABLET / ORALAA2017-10-30
A210211-002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;7.5MGTABLET / ORALAA2017-10-30
A210211-003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;10MGTABLET / ORALAA2017-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210211-001AA
A210211-002AA
A210211-003AA

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210211-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-10-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210211-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-10-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210211-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-10-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210211-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-10-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210211-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-10-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210211-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-10-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A210211-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-10-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210211-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-10-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210211-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-10-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210211-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-10-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210211-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-10-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210211-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-10-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210211-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-10-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210211-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-10-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210211-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-10-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210211-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-10-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210211-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-10-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210211-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-10-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210211-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-10-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210211-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-10-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210211-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-10-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210211-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-10-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210211-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-10-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210211-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-10-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210211-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-10-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210211-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-10-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210211-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-10-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210211-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-10-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A210211-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-10-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A210211-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-10-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210211-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-10-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210211-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-10-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210211-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-10-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210211-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-10-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210211-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-10-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210211-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-10-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210211-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-10-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210211-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-10-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210211-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-10-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210211-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-10-308072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210211-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210211-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210211-003AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210211-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210211-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210211-003AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210211-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210211-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210211-003AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210211-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210211-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210211-003AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210211-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210211-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210211-003AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210211-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210211-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210211-003AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210211-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210211-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210211-003AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210211-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210211-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210211-003AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210211-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210211-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210211-003AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210211-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210211-002AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210211-003AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210211-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210211-002AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210211-003AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210211-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210211-002AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210211-003AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210211-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210211-002AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210211-003AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210211-001AA18072bd15b7f6…

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 BITARTRATE325 mg/1
ACETAMINOPHEN5 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
69ce724d-6440-4def-aea9-26ad284ac35cAvailable 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
63629-8885-1Hydrocodone Bitartrate and Acetaminophen30 in 1 BOTTLETABLET30105
63629-8885-2Hydrocodone Bitartrate and Acetaminophen60 in 1 BOTTLETABLET60105
63629-8885-3Hydrocodone Bitartrate and Acetaminophen90 in 1 BOTTLETABLET90105
63629-8885-4Hydrocodone Bitartrate and Acetaminophen40 in 1 BOTTLETABLET40105
63629-8885-5Hydrocodone Bitartrate and Acetaminophen120 in 1 BOTTLETABLET120105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8885-1EA - Each63629-8885acdaa30a-57da-4549-b654-d7c7fee0db2212021-12-08
63629-8885-2EA - Each63629-88853e459922-48e8-4c45-b277-25ca5e4073e412021-12-08
63629-8885-3EA - Each63629-8885c4692fe3-7b0b-4e50-b49c-c299f6c179f612021-12-08
63629-8885-5EA - Each63629-8885bd100c2e-7454-49b2-8334-ab3b9ce2899212021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8885HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 5 package rows20240913_69ce724d-6440-4def-aea9-26ad284ac35c.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 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack65c5abc7-520a-4267-acb6-ea6204a3ecfa2026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210211
application number: ANDA210211
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack080d8fbd-a2c5-45b1-a9cf-2b6dd42ec4c72026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210211
application number: ANDA210211
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack69ce724d-6440-4def-aea9-26ad284ac35c2026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210211
application number: ANDA210211
ndc (product): 63629-8885
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackf1a7d87c-866d-4c6d-b9fd-e809b0a217732026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210211
application number: ANDA210211
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack1d63d261-bdd4-4951-b8aa-09561e5b19fc2026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210211
application number: ANDA210211
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack09db348f-8396-41b2-b639-608dcfdbccf42026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210211
application number: ANDA210211
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackdb14e63a-8e3e-4524-b45a-cb09f705f73a2026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210211
application number: ANDA210211
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepacke5b559c3-4beb-4ba3-a10b-7a1ad1878a1e2026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210211
application number: ANDA210211
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackc534f784-0e21-4891-8f7e-2dc327b267f12026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210211
application number: ANDA210211
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAsclemed USA, Inc.66e184cd-fa32-431f-b843-9c4bea12593b2026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210211
application number: ANDA210211
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENRedpharm Drug46c13d54-b181-4da2-e063-6294a90ab5c52026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210211
application number: ANDA210211
Hydrocodone/APAPHYDROCODONE/APAPDirect_Rx446e9f78-4034-5bb4-e063-6394a90ac7392026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210211
application number: ANDA210211
Hydrocodone/APAPHYDROCODONE/APAPDirect_Rx446f01f0-2853-d104-e063-6394a90ae3512026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210211
application number: ANDA210211
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENEywa Pharma Incfcd2b59e-8087-475e-9e6b-911bd846ea962025-10-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210211
application number: ANDA210211
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.fed1eb12-3e39-1bf9-e053-6294a90afd772025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210211
application number: ANDA210211
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAmerican Health Packaging9d76aaf6-e3e0-4ec1-9f20-3d5ab88de6302025-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210211
application number: ANDA210211
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.d88e04c1-cd54-6a12-e053-2995a90a22b42024-12-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210211
application number: ANDA210211
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack2a485efe-a87c-4c55-9e17-7891b2fffb832024-09-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210211
application number: ANDA210211
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack42a74abc-bdc7-4ea3-a185-0293401117302024-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210211
application number: ANDA210211
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.c8d65aab-d6ae-bc69-e053-2a95a90a7b5e2024-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210211
application number: ANDA210211

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN69ce724d-6440-4def-aea9-26ad284ac35c105
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD69ce724d-6440-4def-aea9-26ad284ac35c105
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY69ce724d-6440-4def-aea9-26ad284ac35c105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8885-16362988850130 TABLET in 1 BOTTLE (63629-8885-1) 30 tablet2021-10-070000-00-00NoNoCurrent
63629-8885-26362988850260 TABLET in 1 BOTTLE (63629-8885-2) 60 tablet2021-10-070000-00-00NoNoCurrent
63629-8885-36362988850390 TABLET in 1 BOTTLE (63629-8885-3) 90 tablet2021-10-260000-00-00NoNoCurrent
63629-8885-46362988850440 TABLET in 1 BOTTLE (63629-8885-4) 40 tablet2024-09-050000-00-00NoNoCurrent
63629-8885-563629888505120 TABLET in 1 BOTTLE (63629-8885-5) 120 tablet2021-10-260000-00-00NoNoCurrent