ACETAMINOPHEN AND CODEINE PHOSPHATE

Product NDC: 10544-032
11-digit product format: 105440032
Labeler code: 10544
Product ID: 10544-032_3f30a7c7-5db4-426a-b96e-966d03fec82a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: acetaminophen and codeine phosphate
Dosage form: TABLET
Route: ORAL
Labeler: Blenheim Pharmacal, Inc.
Application: ANDA040419
Marketing category: ANDA
Marketing start: 2011-01-31
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength: 300 mg/1; mg/1
DEA schedule: CIII
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	10544-032		I	Inactivated by FDA	2026-08-03
excluded package	package	10544-032	10544-032-15	I	Inactivated by FDA	2026-08-03
excluded package	package	10544-032	10544-032-20	I	Inactivated by FDA	2026-08-03

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31
A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	RS	2001-05-31
A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	RS	2001-05-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040419-001	AA
A040419-002	AA
A040419-003	AA

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 3 · 90 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	RS	2001-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	RS	2001-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	RS	2001-05-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	RS	2001-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	RS	2001-05-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	RS	2001-05-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	RS	2001-05-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA		2001-05-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	RS	2001-05-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA		2001-05-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	RS	2001-05-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA		2001-05-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA		2001-05-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA		2001-05-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	RS	2001-05-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA		2001-05-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	RS	2001-05-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA		2001-05-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	RS	2001-05-31	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA		2001-05-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	RS	2001-05-31	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA		2001-05-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	RS	2001-05-31	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA		2001-05-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA		2001-05-31	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA		2001-05-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`3f01610625f2…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 90 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040419-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040419-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040419-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040419-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040419-002	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040419-003	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040419-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040419-002	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040419-003	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040419-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040419-002	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040419-003	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040419-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040419-002	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040419-003	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040419-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040419-002	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040419-003	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040419-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040419-002	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040419-003	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040419-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040419-002	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040419-003	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040419-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040419-002	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040419-003	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040419-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040419-002	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040419-003	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040419-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040419-002	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040419-003	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040419-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040419-002	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040419-003	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040419-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040419-002	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040419-003	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040419-001	AA	1	`3f01610625f2…`

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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	SpecGx LLC	eadc80fa-13c3-471a-a22f-6fe7e1ab290f	2026-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	Unit Dose Solutions, Inc.	537245e8-5e2a-c3e0-e063-6394a90ac858	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	St. Mary's Medical Park Pharmacy	eac5f350-93e5-4dc2-e053-2a95a90aed60	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	REMEDYREPACK INC.	5c96d033-bf7c-47de-aa0d-5998b3bf4a63	2026-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	A-S Medication Solutions	9ca1321e-380a-48d7-8a58-c6501858c1c0	2026-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	A-S Medication Solutions	dff53120-a609-4720-bd69-2391798c7dee	2026-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	A-S Medication Solutions	297dc9ff-e34f-434b-b1a4-4c995a5bac8b	2026-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	Preferred Pharmaceuticals Inc.	55d494b1-c828-4841-8f64-75b92cd54cb6	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	Preferred Pharmaceuticals Inc.	2453d635-989d-4569-96b3-4efaf61cca71	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	Bryant Ranch Prepack	a6e9b316-549d-4058-8c08-407e4ce5c255	2025-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE	ACETAMINOPHEN AND CODEINE	Direct_Rx	8d7ca633-4448-3507-e053-2a95a90a1287	2025-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE	ACETAMINOPHEN AND CODEINE	Direct_Rx	8d7d6fa4-cc9f-6b4b-e053-2995a90a7286	2025-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	NuCare Pharmaceuticals,Inc.	73e2086e-f513-537f-e053-2991aa0a1348	2025-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
Acetaminophen and Codeine Phosphate	ACETAMINOPHEN AND CODEINE PHOSPHATE	Direct_Rx	e78e50c0-36da-528e-e053-2995a90a3d80	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	Aphena Pharma Solutions - Tennessee, LLC	d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1	2025-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	Quality Care Products, LLC	3b455938-7bbc-4626-939b-40b37709befb	2024-12-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	Bryant Ranch Prepack	3f7737d1-ec78-467e-8903-9cb8eba0ab0b	2024-08-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	Bryant Ranch Prepack	18315a6f-9e89-46d7-81d3-905b8a51aa79	2024-08-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	Proficient Rx LP	a8f8bb34-6d61-47a8-b58b-0b6763458052	2024-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	NuCare Pharmaceuticals,Inc.	6f2ce909-6356-1c2c-e053-2a91aa0a0135	2024-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419

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
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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
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23475c0b-a5b5-4fec-b97f-acca901eae6a	Product name	1	20140718
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10544-032-15	2019-10-29	C162847	48780-1	960f7f55-c6dd-8e05-e053-dbdaa90a074a	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP (300 mg/15 mg, 300 mg/30 mg, 300 mg/60 mg) CIII Rx only
10544-032-20	2019-10-29	C162847	48780-1	960f7f55-c6dd-8e05-e053-dbdaa90a074a	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP (300 mg/15 mg, 300 mg/30 mg, 300 mg/60 mg) CIII Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10544-032-15	ACETAMINOPHEN AND CODEINE PHOSPHATE	15 in 1 BOTTLE	TABLET	15		1
10544-032-20	ACETAMINOPHEN AND CODEINE PHOSPHATE	20 in 1 BOTTLE	TABLET	20		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10544-032-15	EA - Each	10544-032	3570d34a-239b-421e-8d38-a3d345fd9053	1	2015-02-02
10544-032-20	EA - Each	10544-032	d52c7b87-df7f-4d1a-a1e2-d22f65c6e140	1	2015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BLENHEIM PHARMACAL, INC.]	1
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BLENHEIM PHARMACAL, INC.]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BLENHEIM PHARMACAL, INC.]	1
CODEINE	ACTIVE MOIETY	Q830PW7520	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BLENHEIM PHARMACAL, INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BLENHEIM PHARMACAL, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BLENHEIM PHARMACAL, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BLENHEIM PHARMACAL, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BLENHEIM PHARMACAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-032	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BLENHEIM PHARMACAL, INC.]	1	Legacy NDC, 2 package rows	20110420_403f109d-618d-404d-9ce6-11192e6e1796.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
GSL05Y1MN6	CODEINE PHOSPHATE	41444-62-6	CODEINE PHOSPHATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
993781	codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet	PSN	403f109d-618d-404d-9ce6-11192e6e1796	1
993781	acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet	SCD	403f109d-618d-404d-9ce6-11192e6e1796	1
993781	APAP 300 MG / codeine phosphate 30 MG Oral Tablet	SY	403f109d-618d-404d-9ce6-11192e6e1796	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-032-15	10544003215	15 in 1 BOTTLE	Historical
10544-032-20	10544003220	20 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ACETAMINOPHEN AND CODEINE PHOSPHATE	Blenheim Pharmacal, Inc.	2011-04-19	HUMAN PRESCRIPTION DRUG LABEL	1