ACETAMINOPHEN AND CODEINE

Product NDC: 61919-484
11-digit product format: 619190484
Labeler code: 61919
Product ID: 61919-484_2e805755-8d3f-0e94-e063-6294a90a7bc5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ACETAMINOPHEN AND CODEINE
Dosage form: TABLET
Route: ORAL
Labeler: Direct_Rx
Application: ANDA040419
Marketing category: ANDA
Marketing start: 2019-07-12
Substance: ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength: 300; 30 mg/1; mg/1
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61919-484		D	Discontinued by firm	2026-08-03
excluded product	product	61919-484		I	Inactivated by FDA	2026-08-03
excluded package	package	61919-484	61919-484-30	D	Discontinued by firm	2026-08-03
excluded package	package	61919-484	61919-484-60	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 · 99 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
2024-11-08 22:44 UTC · 2 captures of this ZIP	2024-11	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 2 captures of this ZIP	2024-11	A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	RS	2001-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 2 captures of this ZIP	2024-11	A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	RS	2001-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	RS	2001-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	RS	2001-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	RS	2001-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	RS	2001-05-31	`79d66fd596c7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-11-08 22:44 UTC · 2 captures of this ZIP	2024-11	A040419-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 2 captures of this ZIP	2024-11	A040419-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 2 captures of this ZIP	2024-11	A040419-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040419-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040419-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040419-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040419-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040419-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040419-003	AA	1	`79d66fd596c7…`
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…`

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 ndc (product): 61919-484
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 ndc (product): 61919-484
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

Additional Listing Data#

Finished product: Yes
Brand name base: ACETAMINOPHEN AND CODEINE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	300 mg/1
CODEINE PHOSPHATE	30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
GSL05Y1MN6	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
993781	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
8d7d6fa4-cc9f-6b4b-e053-2995a90a7286	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
09d8330d-4fec-be98-3a66-f985140646b2	Product name	2	20210513
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730
e9576821-a971-5261-628e-82ad9e10acdb	Product name	2	20150121
2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
ce055423-1d7f-3c41-dff1-83660fa8cd96	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-484-90	2025-05-02	C162847	48780-1	f386c649-d2ca-0266-e053-dadaa90a7c1a	ACETAMINOPHEN AND CODEINE
61919-484-18	2025-02-19	C162847	48780-1	2cef2736-7133-d83d-e063-dadaa90ab31f	ACETAMINOPHEN AND CODEINE
61919-484-30	2025-02-19	C162847	48780-1	2cef2736-7133-d83d-e063-dadaa90ab31f	ACETAMINOPHEN AND CODEINE
61919-484-71	2025-02-19	C162847	48780-1	2cef2736-7133-d83d-e063-dadaa90ab31f	ACETAMINOPHEN AND CODEINE
61919-484-18	2025-01-30	C162847	48780-1	2cef2736-7133-d83d-e063-dadaa90ab31f	ACETAMINOPHEN AND CODEINE
61919-484-30	2025-01-30	C162847	48780-1	2cef2736-7133-d83d-e063-dadaa90ab31f	ACETAMINOPHEN AND CODEINE
61919-484-71	2025-01-30	C162847	48780-1	2cef2736-7133-d83d-e063-dadaa90ab31f	ACETAMINOPHEN AND CODEINE
61919-484-60	2023-01-30	C162847	48780-1	f386c64a-071c-0266-e053-dadaa90a7c1a	ACETAMINOPHEN AND CODEINE
61919-484-90	2023-01-30	C162847	48780-1	f386c649-d2ca-0266-e053-dadaa90a7c1a	ACETAMINOPHEN AND CODEINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-484-10	ACETAMINOPHEN AND CODEINE	10 in 1 BOTTLE	TABLET	10	7
61919-484-18	ACETAMINOPHEN AND CODEINE	18 in 1 BOTTLE	TABLET	18	7
61919-484-30	ACETAMINOPHEN AND CODEINE	30 in 1 BOTTLE	TABLET	30	7
61919-484-71	ACETAMINOPHEN AND CODEINE	100 in 1 BOTTLE	TABLET	100	7
61919-484-90	ACETAMINOPHEN AND CODEINE	90 in 1 BOTTLE	TABLET	90	2
61919-484-60	ACETAMINOPHEN AND CODEINE	60 in 1 BOTTLE	TABLET	60	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-484-10	EA - Each	61919-484	4e04b85e-b29d-4a30-8967-fb12e9bc2836	1	2025-03-04
61919-484-18	EA - Each	61919-484	05e44a6d-6078-4063-beb2-b46845cb50ca	1	2022-04-06
61919-484-30	EA - Each	61919-484	d5e7df74-5477-4461-8b53-179c459d6ea9	1	2018-04-19
61919-484-90	EA - Each	61919-484	db5da418-31b0-4e4a-9b1b-418ae2082850	1	2025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-484	ACETAMINOPHEN AND CODEINE TABLET [DIRECT_RX]	7	Current NDC, Legacy NDC, 4 package rows	20250221_8d7d6fa4-cc9f-6b4b-e053-2995a90a7286.zip
61919-484	ACETAMINOPHEN AND CODEINE TABLET [DIRECT_RX]	2	Current NDC, Legacy NDC, 1 package rows	20250504_8d7ca633-4448-3507-e053-2a95a90a1287.zip
61919-484	ACETAMINOPHEN AND CODEINE TABLET [DIRECT_RX]	1	Current NDC, Legacy NDC, 1 package rows	20190713_8d7ca347-ad91-0ae1-e053-2995a90ac400.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	8d7d6fa4-cc9f-6b4b-e053-2995a90a7286	7
993781	acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet	SCD	8d7d6fa4-cc9f-6b4b-e053-2995a90a7286	7
993781	APAP 300 MG / codeine phosphate 30 MG Oral Tablet	SY	8d7d6fa4-cc9f-6b4b-e053-2995a90a7286	7
993781	codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet	PSN	8d7ca633-4448-3507-e053-2a95a90a1287	2
993781	acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet	SCD	8d7ca633-4448-3507-e053-2a95a90a1287	2
993781	APAP 300 MG / codeine phosphate 30 MG Oral Tablet	SY	8d7ca633-4448-3507-e053-2a95a90a1287	2
993781	codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet	PSN	8d7ca347-ad91-0ae1-e053-2995a90ac400	1
993781	acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet	SCD	8d7ca347-ad91-0ae1-e053-2995a90ac400	1
993781	APAP 300 MG / codeine phosphate 30 MG Oral Tablet	SY	8d7ca347-ad91-0ae1-e053-2995a90ac400	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-484-10	61919048410	10 TABLET in 1 BOTTLE (61919-484-10)	10 tablet	2019-07-12		No	No	Current
61919-484-18	61919048418	18 TABLET in 1 BOTTLE (61919-484-18)	18 tablet	2019-07-12	0000-00-00	No	No	Current
61919-484-30	61919048430	30 TABLET in 1 BOTTLE (61919-484-30)	30 tablet	2019-07-12	0000-00-00	No	No	Current
61919-484-60	61919048460	60 TABLET in 1 BOTTLE (61919-484-60)	60 tablet	2019-07-12	0000-00-00	No	No	Current
61919-484-71	61919048471	100 TABLET in 1 BOTTLE (61919-484-71)	100 tablet	2019-07-12	0000-00-00	No	No	Current
61919-484-90	61919048490	90 TABLET in 1 BOTTLE (61919-484-90)	90 tablet	2019-07-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ACETAMINOPHEN AND CODEINE	Direct_Rx	2025-04-29	HUMAN PRESCRIPTION DRUG LABEL	2
ACETAMINOPHEN AND CODEINE	Direct_Rx	2025-02-19	HUMAN PRESCRIPTION DRUG LABEL	7
ACETAMINOPHEN AND CODEINE	Direct_Rx	2019-07-12	HUMAN PRESCRIPTION DRUG LABEL	1