BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE

Product NDC: 69238-1993
11-digit product format: 692381993
Labeler code: 69238
Product ID: 69238-1993_f3869a7a-b5f3-4279-b07b-ff01a8c2a286
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE
Dosage form: CAPSULE
Route: ORAL
Labeler: Amneal Pharmaceuticals of New York, LLC
Application: ANDA074951
Marketing category: ANDA
Marketing start: 2019-04-01
Substance: ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Active strength: 325; 50; 40; 30 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	RS	1998-08-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074951-001	AB

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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	RS	1998-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	RS	1998-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	RS	1998-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	RS	1998-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	RS	1998-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	RS	1998-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	RS	1998-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	RS	1998-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	RS	1998-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	RS	1998-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	RS	1998-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	RS	1998-08-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	RS	1998-08-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	RS	1998-08-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	RS	1998-08-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB		1998-08-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB		1998-08-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB		1998-08-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB		1998-08-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB		1998-08-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB		1998-08-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB		1998-08-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB		1998-08-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB		1998-08-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB		1998-08-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB		1998-08-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB		1998-08-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	RS	1998-08-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	RS	1998-08-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	RS	1998-08-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	RS	1998-08-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	RS	1998-08-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	RS	1998-08-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	RS	1998-08-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	RS	1998-08-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	RS	1998-08-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	RS	1998-08-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	RS	1998-08-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	RS	1998-08-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074951-001	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	RS	1998-08-31	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A074951-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074951-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074951-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074951-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074951-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074951-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074951-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074951-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074951-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074951-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074951-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074951-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074951-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074951-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074951-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074951-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074951-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074951-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074951-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074951-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074951-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074951-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074951-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074951-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074951-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074951-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074951-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074951-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074951-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074951-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074951-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074951-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074951-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074951-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074951-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074951-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074951-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074951-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074951-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074951-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUTALBITAL	325 mg/1
ASPIRIN	50 mg/1
CAFFEINE	40 mg/1
CODEINE PHOSPHATE	30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
KHS0AZ4JVK	Internal UNII lookup
R16CO5Y76E	Internal UNII lookup
3G6A5W338E	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
994237	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
828e30fa-7bb1-486b-80ee-806fce45e4e4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
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
d7724692-1155-4cc8-a415-22f5fc4aec35	Product name	6	20220216
09d8330d-4fec-be98-3a66-f985140646b2	Product name	2	20210513
bde672ba-4805-28d0-1986-73543d41b412	Product name	2	20210201
2dc76302-91c0-4c35-ad78-99adfb049c4b	Product name	1	20200603
103b151b-b17f-42ac-8624-3ef62f5e2975	Product name	2	20200507
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
e6065d4b-5ae1-476f-a40e-f2851cbb5d2b	Product name	2	20180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657	Product name	1	20150929
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
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
56625fcc-aa34-9d30-d0e9-1c1beb37ea21	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94e	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
ce055423-1d7f-3c41-dff1-83660fa8cd96	Product name	1	20140508
d223c173-c39b-d764-47d4-d671d3088815	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69238-1993-1	2023-02-03	C162847	48780-1	f386c64a-2abd-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE capsules safely and effectively. See full prescribing information for BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE. BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE capsules, USP, for oral use Initial U.S. Approval: 1990
69238-1993-1	2023-01-30	C162847	48780-1	f386c64a-2abd-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE capsules safely and effectively. See full prescribing information for BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE. BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE capsules, USP, for oral use Initial U.S. Approval: 1990

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69238-1993-1	BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE	100 in 1 BOTTLE	CAPSULE	100		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69238-1993-1	EA - Each	69238-1993	dee90535-c73b-44c7-bc6b-ac2fb0a68d4d	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69238-1993	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	7	Current NDC, Legacy NDC, 1 package rows	20241206_828e30fa-7bb1-486b-80ee-806fce45e4e4.zip

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE	Amneal Pharmaceuticals of New York, LLC	828e30fa-7bb1-486b-80ee-806fce45e4e4	2026-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074951 application number: ANDA074951 ndc (product): 69238-1993

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R16CO5Y76E	ASPIRIN	50-78-2	ASPIRIN
KHS0AZ4JVK	BUTALBITAL	77-26-9	BUTALBITAL
3G6A5W338E	CAFFEINE	58-08-2	CAFFEINE
GSL05Y1MN6	CODEINE PHOSPHATE	41444-62-6	CODEINE PHOSPHATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
994237	butalbital 50 MG / aspirin 325 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule	PSN	828e30fa-7bb1-486b-80ee-806fce45e4e4	8
994237	aspirin 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule	SCD	828e30fa-7bb1-486b-80ee-806fce45e4e4	8
994237	ASA 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule	SY	828e30fa-7bb1-486b-80ee-806fce45e4e4	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69238-1993-1	69238199301	100 CAPSULE in 1 BOTTLE (69238-1993-1)	100 capsule	2019-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE	Amneal Pharmaceuticals of New York, LLC \| Jerome Stevens Pharmaceuticals, Inc.	2026-01-15	HUMAN PRESCRIPTION DRUG LABEL	8