FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
63187-778
11-digit product format
631870778
Labeler code
63187
Product ID
63187-778_156868e3-86ea-4689-90b4-734d29634b29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA201013
Marketing category
ANDA
Marketing start
2012-04-12
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325; 10 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
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
A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;5MGTABLET / ORALAA2012-04-11
A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;7.5MGTABLET / ORALAA2012-04-11
A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;10MGTABLET / ORALAA2012-04-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201013-001AA
A201013-002AA
A201013-003AA

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 UTC2026-02A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-118072bd15b7f6…

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 UTC2026-02A201013-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201013-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201013-003AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201013-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201013-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201013-003AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201013-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201013-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201013-003AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201013-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201013-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201013-003AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201013-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201013-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201013-003AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201013-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201013-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201013-003AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201013-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201013-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201013-003AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201013-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201013-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201013-003AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201013-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201013-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201013-003AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201013-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201013-002AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201013-003AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201013-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201013-002AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201013-003AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201013-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201013-002AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201013-003AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201013-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201013-002AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201013-003AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201013-001AA18072bd15b7f6…

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackddfe71cc-27bf-4807-b62f-e6cf982e2dfd2026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack88c031ee-3d3d-4e8a-b69b-d18db612a9f32026-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAurolife Pharma, LLC60f43308-1deb-4f05-8f17-aa49ebdcf4982025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack59a92d79-5b2d-4c10-b0ac-ea766a0ff08b2024-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.8b132cf3-c138-59ae-e053-2995a90a98a22024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.8c2a7a68-5a84-c909-e053-2995a90ad5b62024-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.8592e901-9353-6fb6-e053-2a91aa0ad33b2024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.86be8920-2f35-fbc3-e053-2991aa0a00152024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LP82b24978-8b15-43a9-b5b0-3313ed2a73c22023-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LPe6711f26-a01d-43e8-882a-d58561e4b67f2022-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LP199d4915-cb3b-48f3-835d-a45d04a5c9402022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
ndc (product): 63187-778

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrocodone Bitartrate and Acetaminophen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCODONE BITARTRATE325 mg/1
ACETAMINOPHEN10 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
856999Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
199d4915-cb3b-48f3-835d-a45d04a5c940Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
53523715-c529-4d52-b9ff-1e5d76636f53Product name220210818
31b11e56-5b35-4ab6-a3a8-f0b48973dcedProduct name220200611
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
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
377068df-225f-7318-a910-a1987cdfa361Product name320170608
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
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-778-12Hydrocodone Bitartrate and Acetaminophen12 in 1 BOTTLETABLET126
63187-778-15Hydrocodone Bitartrate and Acetaminophen15 in 1 BOTTLETABLET156
63187-778-20Hydrocodone Bitartrate and Acetaminophen20 in 1 BOTTLETABLET206
63187-778-30Hydrocodone Bitartrate and Acetaminophen30 in 1 BOTTLETABLET306
63187-778-60Hydrocodone Bitartrate and Acetaminophen60 in 1 BOTTLETABLET606
63187-778-90Hydrocodone Bitartrate and Acetaminophen90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-778-12EA - Each63187-778cc3b012c-b3e7-4056-8717-c1f10969631b12022-04-06
63187-778-15EA - Each63187-77862f02fa1-2ab3-4713-b1c6-2000022bdbc212017-03-06
63187-778-20EA - Each63187-778040067f6-a258-49ad-8bdd-a7fc98f6962312017-07-07
63187-778-30EA - Each63187-7784700b1f0-1368-426f-8c45-bc1991f99bf412017-03-06
63187-778-60EA - Each63187-778fc71210c-9044-4529-a484-4121ce1430f212017-03-06
63187-778-90EA - Each63187-77839221f38-dbe7-4bb3-884d-a8b7f466570912017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-778HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PROFICIENT RX LP]6Current NDC, Legacy NDC, 6 package rows20220426_199d4915-cb3b-48f3-835d-a45d04a5c940.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN199d4915-cb3b-48f3-835d-a45d04a5c9406
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD199d4915-cb3b-48f3-835d-a45d04a5c9406
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY199d4915-cb3b-48f3-835d-a45d04a5c9406

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-778-126318707781212 TABLET in 1 BOTTLE (63187-778-12) 12 tablet2016-11-010000-00-00NoNoCurrent
63187-778-156318707781515 TABLET in 1 BOTTLE (63187-778-15) 15 tablet2017-02-010000-00-00NoNoCurrent
63187-778-206318707782020 TABLET in 1 BOTTLE (63187-778-20) 20 tablet2016-11-010000-00-00NoNoCurrent
63187-778-306318707783030 TABLET in 1 BOTTLE (63187-778-30) 30 tablet2016-11-010000-00-00NoNoCurrent
63187-778-606318707786060 TABLET in 1 BOTTLE (63187-778-60) 60 tablet2016-11-010000-00-00NoNoCurrent
63187-778-906318707789090 TABLET in 1 BOTTLE (63187-778-90) 90 tablet2017-02-010000-00-00NoNoCurrent