ACETAMINOPHEN AND CODEINE PHOSPHATE

Product NDC: 0406-0483
11-digit product format: 004060483
Labeler code: 0406
Product ID: 0406-0483_d718c5ef-69f7-4342-8ac6-772b45f6a726
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: acetaminophen and codeine phosphate
Dosage form: TABLET
Route: ORAL
Labeler: SpecGx LLC
Application: ANDA040419
Marketing category: ANDA
Marketing start: 2001-05-31
Substance: ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength: 300; 15 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

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 · 102 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
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	RS	2001-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	RS	2001-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 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 · 3 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 · 3 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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040419-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040419-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040419-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040419-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040419-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 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…`

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 ndc (product): 0406-0483
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

Additional Listing Data#

Finished product: Yes
Brand name base: ACETAMINOPHEN AND CODEINE PHOSPHATE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	300 mg/1
CODEINE PHOSPHATE	15 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
993770	Internal RxNorm lookup
993781	Internal RxNorm lookup
993890	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
eadc80fa-13c3-471a-a22f-6fe7e1ab290f	Available on FDA.report

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
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41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
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06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
92ead9ae-674d-4eee-a492-c385d496891f	Product name	3	20220308
09d8330d-4fec-be98-3a66-f985140646b2	Product name	2	20210513
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
377068df-225f-7318-a910-a1987cdfa361	Product name	3	20170608
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
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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
23475c0b-a5b5-4fec-b97f-acca901eae6a	Product name	1	20140718
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
30c51294-7ae9-8007-7de6-58222684a0be	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
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
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cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ce	Product name	1	20140508
ce055423-1d7f-3c41-dff1-83660fa8cd96	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0406-0483-01	ACETAMINOPHEN AND CODEINE PHOSPHATE	100 in 1 BOTTLE	TABLET	100		50

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0406-0483-01	EA - Each	0406-0483	a52ae884-c122-48a1-90b7-2e49b5d99258	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [MALLINCKRODT, INC.]	17
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [MALLINCKRODT, INC.]	17
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [MALLINCKRODT, INC.]	17
CODEINE ANHYDROUS	ACTIVE MOIETY	UX6OWY2V7J	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [MALLINCKRODT, INC.]	17
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [MALLINCKRODT, INC.]	17
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [MALLINCKRODT, INC.]	17
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [MALLINCKRODT, INC.]	17
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [MALLINCKRODT, INC.]	17
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [MALLINCKRODT, INC.]	17
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [MALLINCKRODT, INC.]	17
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
CODEINE ANHYDROUS	ACTIVE MOIETY	UX6OWY2V7J	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CODEINE ANHYDROUS	ACTIVE MOIETY	UX6OWY2V7J	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DISPENSING SOLUTIONS, INC.]	1
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DISPENSING SOLUTIONS, INC.]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DISPENSING SOLUTIONS, INC.]	1
CODEINE	ACTIVE MOIETY	Q830PW7520	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DISPENSING SOLUTIONS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DISPENSING SOLUTIONS, INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DISPENSING SOLUTIONS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DISPENSING SOLUTIONS, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DISPENSING SOLUTIONS, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DISPENSING SOLUTIONS, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DISPENSING SOLUTIONS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0406-0483	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [SPECGX LLC]	48	Current NDC, Legacy NDC, 1 package rows	20250419_eadc80fa-13c3-471a-a22f-6fe7e1ab290f.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
993770	codeine phosphate 15 MG / acetaminophen 300 MG Oral Tablet	PSN	eadc80fa-13c3-471a-a22f-6fe7e1ab290f	50
993781	codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet	PSN	eadc80fa-13c3-471a-a22f-6fe7e1ab290f	50
993890	codeine phosphate 60 MG / acetaminophen 300 MG Oral Tablet	PSN	eadc80fa-13c3-471a-a22f-6fe7e1ab290f	50
993770	acetaminophen 300 MG / codeine phosphate 15 MG Oral Tablet	SCD	eadc80fa-13c3-471a-a22f-6fe7e1ab290f	50
993781	acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet	SCD	eadc80fa-13c3-471a-a22f-6fe7e1ab290f	50
993890	acetaminophen 300 MG / codeine phosphate 60 MG Oral Tablet	SCD	eadc80fa-13c3-471a-a22f-6fe7e1ab290f	50
993770	APAP 300 MG / codeine phosphate 15 MG Oral Tablet	SY	eadc80fa-13c3-471a-a22f-6fe7e1ab290f	50
993781	APAP 300 MG / codeine phosphate 30 MG Oral Tablet	SY	eadc80fa-13c3-471a-a22f-6fe7e1ab290f	50
993890	APAP 300 MG / codeine phosphate 60 MG Oral Tablet	SY	eadc80fa-13c3-471a-a22f-6fe7e1ab290f	50
993770	codeine phosphate 15 MG / acetaminophen 300 MG Oral Tablet	PSN	d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1	5
993781	codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet	PSN	d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1	5
993890	codeine phosphate 60 MG / acetaminophen 300 MG Oral Tablet	PSN	d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1	5
993770	acetaminophen 300 MG / codeine phosphate 15 MG Oral Tablet	SCD	d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1	5
993781	acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet	SCD	d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1	5
993890	acetaminophen 300 MG / codeine phosphate 60 MG Oral Tablet	SCD	d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1	5
993770	APAP 300 MG / codeine phosphate 15 MG Oral Tablet	SY	d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1	5
993781	APAP 300 MG / codeine phosphate 30 MG Oral Tablet	SY	d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1	5
993890	APAP 300 MG / codeine phosphate 60 MG Oral Tablet	SY	d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1	5
993770	codeine phosphate 15 MG / acetaminophen 300 MG Oral Tablet	PSN	0332c7ca-7522-4fb5-96ea-2abe47322119	4
993781	codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet	PSN	0332c7ca-7522-4fb5-96ea-2abe47322119	4
993890	codeine phosphate 60 MG / acetaminophen 300 MG Oral Tablet	PSN	0332c7ca-7522-4fb5-96ea-2abe47322119	4
993770	acetaminophen 300 MG / codeine phosphate 15 MG Oral Tablet	SCD	0332c7ca-7522-4fb5-96ea-2abe47322119	4
993781	acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet	SCD	0332c7ca-7522-4fb5-96ea-2abe47322119	4
993890	acetaminophen 300 MG / codeine phosphate 60 MG Oral Tablet	SCD	0332c7ca-7522-4fb5-96ea-2abe47322119	4
993770	APAP 300 MG / codeine phosphate 15 MG Oral Tablet	SY	0332c7ca-7522-4fb5-96ea-2abe47322119	4
993781	APAP 300 MG / codeine phosphate 30 MG Oral Tablet	SY	0332c7ca-7522-4fb5-96ea-2abe47322119	4
993890	APAP 300 MG / codeine phosphate 60 MG Oral Tablet	SY	0332c7ca-7522-4fb5-96ea-2abe47322119	4
993770	codeine phosphate 15 MG / acetaminophen 300 MG Oral Tablet	PSN	5f1bf60d-62a2-437e-8273-5d699decd1ff	1
993770	acetaminophen 300 MG / codeine phosphate 15 MG Oral Tablet	SCD	5f1bf60d-62a2-437e-8273-5d699decd1ff	1
993770	APAP 300 MG / codeine phosphate 15 MG Oral Tablet	SY	5f1bf60d-62a2-437e-8273-5d699decd1ff	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0406-0483-01	00406048301	100 TABLET in 1 BOTTLE (0406-0483-01)	100 tablet	2001-05-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetaminophen and Codeine Phosphate Tablets USP CIII	SpecGx LLC	2026-06-12	HUMAN PRESCRIPTION DRUG LABEL	51
ACETAMINOPHEN AND CODEINE PHOSPHATE	Aphena Pharma Solutions - Tennessee, LLC	2025-01-08	HUMAN PRESCRIPTION DRUG LABEL	5
ACETAMINOPHEN AND CODEINE PHOSPHATE	Physicians Total Care, Inc.	2012-09-24	HUMAN PRESCRIPTION DRUG LABEL	4
ACETAMINOPHEN AND CODEINE PHOSPHATE	Dispensing Solutions, Inc.	2011-09-30	HUMAN PRESCRIPTION DRUG LABEL	1