Application 212418

Type: ANDA
Sponsor: ELITE LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	TABLET;ORAL	300MG;15MG	No	No
002	ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	TABLET;ORAL	300MG;30MG	No	No
003	ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	TABLET;ORAL	300MG;60MG	No	No

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	Approval date
A212418-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2019-09-10
A212418-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2019-09-10
A212418-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2019-09-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212418-001	AA
A212418-002	AA
A212418-003	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 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212418-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2019-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212418-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2019-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212418-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2019-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212418-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2019-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212418-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2019-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212418-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2019-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212418-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2019-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212418-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2019-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212418-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2019-09-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212418-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2019-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212418-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2019-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212418-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2019-09-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212418-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2019-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212418-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2019-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212418-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2019-09-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212418-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2019-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212418-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2019-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212418-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2019-09-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212418-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2019-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212418-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2019-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212418-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2019-09-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212418-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2019-09-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212418-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2019-09-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212418-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2019-09-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212418-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2019-09-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212418-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2019-09-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212418-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2019-09-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212418-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2019-09-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212418-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2019-09-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212418-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2019-09-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212418-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2019-09-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212418-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2019-09-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212418-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2019-09-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212418-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2019-09-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212418-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2019-09-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212418-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2019-09-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212418-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2019-09-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212418-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2019-09-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212418-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2019-09-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212418-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2019-09-10	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212418-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212418-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212418-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212418-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212418-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212418-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212418-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212418-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212418-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212418-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212418-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212418-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212418-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212418-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212418-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212418-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212418-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212418-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212418-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212418-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212418-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212418-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212418-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212418-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212418-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212418-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212418-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212418-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212418-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212418-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212418-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212418-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212418-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212418-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212418-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212418-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212418-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212418-002	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212418-003	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212418-001	AA	1	`8072bd15b7f6…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 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	Proficient Rx LP	6980bfc5-15e4-48ec-9346-6f09f8f78900	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212418 application number: ANDA212418
Acetaminophen and Codeine Phosphate	ACETAMINOPHEN AND CODEINE PHOSPHATE	Elite Laboratories, Inc.	6286e128-1288-4dc0-b14b-f04a0e2a22f9	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212418 application number: ANDA212418 ndc (product): 64850-641 ndc (product): 64850-642 ndc (product): 64850-643
Acetaminophen and Codeine Phosphate	ACETAMINOPHEN AND CODEINE PHOSPHATE	Advanced Rx of Tennessee, LLC	3698e0ff-6a1c-e1ad-e063-6294a90a163a	2025-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212418 application number: ANDA212418
Acetaminophen and Codeine Phosphate	ACETAMINOPHEN AND CODEINE PHOSPHATE	NuCare Pharmaceuticals, Inc.	2e88442f-a6a9-a899-e063-6294a90ac08d	2025-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212418 application number: ANDA212418

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64850-641	Acetaminophen and Codeine Phosphate	Acetaminophen and Codeine Phosphate	Elite Laboratories, Inc.	ANDA	Current
64850-641	Acetaminophen and Codeine Phosphate	Acetaminophen and Codeine Phosphate	Elite Laboratories, Inc.	ANDA	Current
64850-641	Acetaminophen and Codeine Phosphate	Acetaminophen and Codeine Phosphate	Elite Laboratories, Inc.	ANDA	Current
64850-642	Acetaminophen and Codeine Phosphate	Acetaminophen and Codeine Phosphate	Elite Laboratories, Inc.	ANDA	Current
64850-642	Acetaminophen and Codeine Phosphate	Acetaminophen and Codeine Phosphate	Elite Laboratories, Inc.	ANDA	Current
64850-642	Acetaminophen and Codeine Phosphate	Acetaminophen and Codeine Phosphate	Elite Laboratories, Inc.	ANDA	Current
64850-643	Acetaminophen and Codeine Phosphate	Acetaminophen and Codeine Phosphate	Elite Laboratories, Inc.	ANDA	Current
64850-643	Acetaminophen and Codeine Phosphate	Acetaminophen and Codeine Phosphate	Elite Laboratories, Inc.	ANDA	Current
64850-643	Acetaminophen and Codeine Phosphate	Acetaminophen and Codeine Phosphate	Elite Laboratories, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76448	ORIG	2023-11-07