Acetaminophen and Codeine Phosphate

Product NDC: 63629-1494
11-digit product format: 636291494
Labeler code: 63629
Product ID: 63629-1494_898491ae-5708-43c1-9632-47a64db42ecf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acetaminophen and Codeine Phosphate
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA088628
Marketing category: ANDA
Marketing start: 1990-09-30
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength: 300 mg/1; mg/1
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 2021-12-31
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	63629-1494		D	Discontinued by firm	2026-10-05
excluded package	package	63629-1494	63629-1494-0	D	Discontinued by firm	2026-10-05
excluded package	package	63629-1494	63629-1494-1	D	Discontinued by firm	2026-10-05
excluded package	package	63629-1494	63629-1494-2	D	Discontinued by firm	2026-10-05
excluded package	package	63629-1494	63629-1494-3	D	Discontinued by firm	2026-10-05
excluded package	package	63629-1494	63629-1494-4	D	Discontinued by firm	2026-10-05
excluded package	package	63629-1494	63629-1494-5	D	Discontinued by firm	2026-10-05
excluded package	package	63629-1494	63629-1494-6	D	Discontinued by firm	2026-10-05
excluded package	package	63629-1494	63629-1494-7	D	Discontinued by firm	2026-10-05
excluded package	package	63629-1494	63629-1494-8	D	Discontinued by firm	2026-10-05
excluded package	package	63629-1494	63629-1494-9	D	Discontinued by firm	2026-10-05

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 3 · 132 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	63629-1494-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-1494-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-1494-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-1494-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-1494-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-1494-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-1494-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-1494-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-1494-7	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-1494-2	`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	63629-1494-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-1494-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-1494-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-1494-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-1494-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-1494-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-1494-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-1494-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-1494-7	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-1494-2	`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	63629-1494-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-1494-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-1494-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-1494-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-1494-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-1494-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-1494-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-1494-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-1494-7	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-1494-2	`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	63629-1494-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-1494-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-1494-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-1494-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-1494-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-1494-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-1494-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-1494-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-1494-7	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-1494-2	`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	63629-1494-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-1494-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-1494-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-1494-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-1494-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-1494-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-1494-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-1494-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-1494-7	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-1494-2	`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	63629-1494-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-1494-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-1494-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-1494-4	`cdf11ea48f46…`	`ba0047e9e063…`

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A088628-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1985-03-06	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088628-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1985-03-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088628-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1985-03-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088628-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1985-03-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088628-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1985-03-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088628-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1985-03-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088628-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1985-03-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088628-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1985-03-06	`ea99ee380514…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A088628-001	AA	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088628-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088628-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088628-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088628-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088628-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088628-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088628-001	AA	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-1494-0	EA - Each	63629-1494	b86d13f7-940f-4972-b2fd-fcc17c4022d9	1	2013-02-13
63629-1494-1	EA - Each	63629-1494	1c6441bc-59d1-4002-b34a-cda7ec07478f	1	2013-02-13
63629-1494-2	EA - Each	63629-1494	ba9bbbf1-fd33-4fc4-98f6-039fb1aa2625	1	2013-02-13
63629-1494-3	EA - Each	63629-1494	89d55af5-cff5-4fa5-ac96-94e13dac99c7	1	2013-02-13
63629-1494-4	EA - Each	63629-1494	15d80cd1-90da-47ca-85b5-3ed68de5da54	1	2013-02-13
63629-1494-5	EA - Each	63629-1494	ede9595b-9bec-46d3-b827-71e04d56279e	1	2013-02-13
63629-1494-6	EA - Each	63629-1494	b7868bca-acbb-4d79-ad4c-f6bbeb4096b1	1	2013-02-13
63629-1494-7	EA - Each	63629-1494	9af567be-565c-4dff-89e9-89717a2c64a9	1	2013-02-13
63629-1494-8	EA - Each	63629-1494	84d0d49d-8168-49b2-b6e6-d5b2960772e8	1	2013-02-13
63629-1494-9	EA - Each	63629-1494	cc48c9f1-7c04-4b04-a140-becfc4ff5854	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BRYANT RANCH PREPACK]	1000
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BRYANT RANCH PREPACK]	1000
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BRYANT RANCH PREPACK]	1000
CODEINE ANHYDROUS	ACTIVE MOIETY	UX6OWY2V7J	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BRYANT RANCH PREPACK]	1000
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BRYANT RANCH PREPACK]	1000
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BRYANT RANCH PREPACK]	1000
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BRYANT RANCH PREPACK]	1000
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BRYANT RANCH PREPACK]	1000

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-1494-0	63629149400	40 TABLET in 1 BOTTLE (63629-1494-0)	40 tablet	2005-10-07	0000-00-00	No	No	Current
63629-1494-1	63629149401	6 TABLET in 1 BOTTLE (63629-1494-1)	6 tablet	2005-10-07	0000-00-00	No	No	Current
63629-1494-2	63629149402	20 TABLET in 1 BOTTLE (63629-1494-2)	20 tablet	2005-10-07	0000-00-00	No	No	Current
63629-1494-3	63629149403	30 TABLET in 1 BOTTLE (63629-1494-3)	30 tablet	2005-10-07	0000-00-00	No	No	Current
63629-1494-4	63629149404	84 TABLET in 1 BOTTLE (63629-1494-4)	84 tablet	2005-10-07	0000-00-00	No	No	Current
63629-1494-5	63629149405	15 TABLET in 1 BOTTLE (63629-1494-5)	15 tablet	2005-10-07	0000-00-00	No	No	Current
63629-1494-6	63629149406	120 TABLET in 1 BOTTLE (63629-1494-6)	120 tablet	2005-10-07	0000-00-00	No	No	Current
63629-1494-7	63629149407	100 TABLET in 1 BOTTLE (63629-1494-7)	100 tablet	2005-10-07	0000-00-00	No	No	Current
63629-1494-8	63629149408	60 TABLET in 1 BOTTLE (63629-1494-8)	60 tablet	2005-10-07	0000-00-00	No	No	Current
63629-1494-9	63629149409	90 TABLET in 1 BOTTLE (63629-1494-9)	90 tablet	2005-10-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only	Bryant Ranch Prepack	2020-09-24	HUMAN PRESCRIPTION DRUG LABEL	1004