HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product NDC: 68387-230
11-digit product format: 683870230
Labeler code: 68387
Product ID: 68387-230_5d819e04-2719-49b2-be5c-f7967563b3fa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage form: TABLET
Route: ORAL
Labeler: Keltman Pharmaceuticals Inc.
Application: ANDA089699
Marketing category: ANDA
Marketing start: 2010-07-01
Marketing end: 0000-00-00
Substance: HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength: 8 mg/1; mg/1
Pharmacologic classes: Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule: CIII
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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 · 11 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68387-230		I	Inactivated by FDA	2026-08-17
excluded package	package	68387-230	68387-230-01	I	Inactivated by FDA	2026-08-17
excluded package	package	68387-230	68387-230-10	I	Inactivated by FDA	2026-08-17
excluded package	package	68387-230	68387-230-12	I	Inactivated by FDA	2026-08-17
excluded package	package	68387-230	68387-230-15	I	Inactivated by FDA	2026-08-17
excluded package	package	68387-230	68387-230-30	I	Inactivated by FDA	2026-08-17
excluded package	package	68387-230	68387-230-40	I	Inactivated by FDA	2026-08-17
excluded package	package	68387-230	68387-230-50	I	Inactivated by FDA	2026-08-17
excluded package	package	68387-230	68387-230-51	I	Inactivated by FDA	2026-08-17
excluded package	package	68387-230	68387-230-60	I	Inactivated by FDA	2026-08-17
excluded package	package	68387-230	68387-230-90	I	Inactivated by FDA	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 5 · 242 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68387-230-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68387-230-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68387-230-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68387-230-51	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68387-230-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68387-230-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68387-230-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68387-230-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68387-230-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68387-230-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68387-230-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68387-230-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68387-230-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68387-230-51	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68387-230-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68387-230-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68387-230-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68387-230-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68387-230-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68387-230-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68387-230-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68387-230-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68387-230-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68387-230-51	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68387-230-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68387-230-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68387-230-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68387-230-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68387-230-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68387-230-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68387-230-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68387-230-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68387-230-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68387-230-51	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68387-230-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68387-230-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68387-230-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68387-230-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68387-230-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68387-230-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68387-230-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68387-230-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68387-230-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68387-230-51	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68387-230-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68387-230-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68387-230-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68387-230-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68387-230-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68387-230-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68387-230-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68387-230-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68387-230-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68387-230-51	`cdf11ea48f46…`	`ba0047e9e063…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	500MG;7.5MG	TABLET / ORAL			1989-08-25

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089699-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;7.5MG	TABLET / ORAL	1989-08-25	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
75d4bef7-334c-4a95-abb5-bff9def24114	Product name	2	20260112
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7f	Product name	5	20250115
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
88300afc-e1c4-ad17-c80b-4957f1b809a5	Product name	5	20250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043	Product name	7	20240611
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66f	Product name	1	20230808
a3631b20-02d1-41d7-8187-5e5e850b9e80	Product name	1	20230306
79e1734e-f721-4d46-978a-be382f771672	Product name	2	20230110
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
92ead9ae-674d-4eee-a492-c385d496891f	Product name	3	20220308
53523715-c529-4d52-b9ff-1e5d76636f53	Product name	2	20210818
31b11e56-5b35-4ab6-a3a8-f0b48973dced	Product name	2	20200611
103b151b-b17f-42ac-8624-3ef62f5e2975	Product name	2	20200507
b8497372-efe9-9dde-fa2d-59be9761aa64	Product name	9	20200428
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880	Product name	1	20190320
00d531e4-b130-8c52-eaf9-826cbb6f15dd	Product name	3	20190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659	Product name	9	20190205
22d922aa-c443-d9f3-b23c-03b03a9ad31c	Product name	7	20181220
7855f8e3-562e-4273-8b79-0059c07a71f7	Product name	1	20170901
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
377068df-225f-7318-a910-a1987cdfa361	Product name	3	20170608
a5244f9c-cd67-0e27-d63b-65fd7e584400	Product name	2	20170504
b654f2d9-ebeb-451d-96ee-22f583344623	Product name	1	20170424
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
23475c0b-a5b5-4fec-b97f-acca901eae6a	Product name	1	20140718
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
3ed6b849-48b8-8899-c288-6eeb396123b6	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
96c5169b-5b9d-547d-bf22-d688d91866e4	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
c8753a88-edde-8e17-a396-705537b52cee	Product name	1	20140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ce	Product name	1	20140508
cf3a804d-0326-aa22-0142-c184b5657d85	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
68387-230-01	hydrocodone bitartrate and acetaminophen tablet
68387-230-10	hydrocodone bitartrate and acetaminophen tablet
68387-230-12	hydrocodone bitartrate and acetaminophen tablet
68387-230-15	hydrocodone bitartrate and acetaminophen tablet
68387-230-30	hydrocodone bitartrate and acetaminophen tablet
68387-230-40	hydrocodone bitartrate and acetaminophen tablet
68387-230-50	hydrocodone bitartrate and acetaminophen tablet
68387-230-51	hydrocodone bitartrate and acetaminophen tablet
68387-230-60	hydrocodone bitartrate and acetaminophen tablet
68387-230-90	hydrocodone bitartrate and acetaminophen tablet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68387-230-01	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	100 in 1 BOTTLE, PLASTIC	TABLET	100	3
68387-230-10	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	10 in 1 BOTTLE, PLASTIC	TABLET	10	3
68387-230-12	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	120 in 1 BOTTLE, PLASTIC	TABLET	120	3
68387-230-15	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	15 in 1 BOTTLE, PLASTIC	TABLET	15	3
68387-230-30	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	30 in 1 BOTTLE, PLASTIC	TABLET	30	3
68387-230-40	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	40 in 1 BOTTLE, PLASTIC	TABLET	40	3
68387-230-50	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	50 in 1 BOTTLE, PLASTIC	TABLET	50	3
68387-230-51	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	150 in 1 BOTTLE, PLASTIC	TABLET	150	3
68387-230-60	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	60 in 1 BOTTLE, PLASTIC	TABLET	60	3
68387-230-90	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	90 in 1 BOTTLE, PLASTIC	TABLET	90	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68387-230-01	EA - Each	68387-230	b2a36418-374c-4877-ab94-a1a6f745863a	1	2012-07-24
68387-230-10	EA - Each	68387-230	734246ec-7ff0-44b9-82ec-61ab3bd5ba79	1	2012-07-24
68387-230-12	EA - Each	68387-230	b91c64a4-e711-41f2-9854-e9f1a13ce6f4	1	2012-07-24
68387-230-15	EA - Each	68387-230	ddb1017d-fd3b-43b0-a5f5-0e95595c4c4a	1	2012-07-24
68387-230-30	EA - Each	68387-230	082d1af1-bbd0-470f-9368-a16f22bd0b31	1	2012-07-24
68387-230-40	EA - Each	68387-230	c6fae3a1-ad15-4d4b-abb8-07950838753d	1	2012-07-24
68387-230-50	EA - Each	68387-230	cd7c5a4b-b2dd-4686-8dcb-20ed62be5c55	1	2012-07-24
68387-230-51	EA - Each	68387-230	7bcebc9f-c4dc-4b14-a62e-b53f3d2014a8	1	2012-07-24
68387-230-60	EA - Each	68387-230	aa1a3830-421a-4f61-aa2f-d4068adf7750	1	2012-07-24
68387-230-90	EA - Each	68387-230	8188f10a-b4a1-48a9-9f50-f73adcd74374	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]	3
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]	3
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]	3
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68387-230	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]	3	Legacy NDC, 10 package rows	20101223_0af451fc-67e6-454b-88e7-ab5746f6dbb5.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NO70W886KK	HYDROCODONE BITARTRATE	34195-34-1	HYDROCODONE BITARTRATE
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
857118	HYDROcodone bitartrate 7.5 MG / acetaminophen 500 MG Oral Tablet	PSN	0af451fc-67e6-454b-88e7-ab5746f6dbb5	3
857118	acetaminophen 500 MG / hydrocodone bitartrate 7.5 MG Oral Tablet	SCD	0af451fc-67e6-454b-88e7-ab5746f6dbb5	3
857118	APAP 500 MG / hydrocodone bitartrate 7.5 MG Oral Tablet	SY	0af451fc-67e6-454b-88e7-ab5746f6dbb5	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68387-230-01	68387023001	100 in 1 BOTTLE, PLASTIC	Historical
68387-230-10	68387023010	10 in 1 BOTTLE, PLASTIC	Historical
68387-230-12	68387023012	120 in 1 BOTTLE, PLASTIC	Historical
68387-230-15	68387023015	15 in 1 BOTTLE, PLASTIC	Historical
68387-230-30	68387023030	30 in 1 BOTTLE, PLASTIC	Historical
68387-230-40	68387023040	40 in 1 BOTTLE, PLASTIC	Historical
68387-230-50	68387023050	50 in 1 BOTTLE, PLASTIC	Historical
68387-230-51	68387023051	150 in 1 BOTTLE, PLASTIC	Historical
68387-230-60	68387023060	60 in 1 BOTTLE, PLASTIC	Historical
68387-230-90	68387023090	90 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
hydrocodone bitartrate and acetaminophen tablet	Keltman Pharmaceuticals Inc.	2010-12-10	HUMAN PRESCRIPTION DRUG LABEL	3