acamprosate calcium

Product NDC: 70518-4616
11-digit product format: 705184616
Labeler code: 70518
Product ID: 70518-4616_5216f438-5ac5-eb94-e063-6394a90a5d5c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: acamprosate calcium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA205995
Marketing category: ANDA
Marketing start: 2026-04-23
Substance: ACAMPROSATE CALCIUM
Active strength: 333 mg/1
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
A205995-001	ACAMPROSATE CALCIUM	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205995-001	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	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-05-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-05-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-05-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-05-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-05-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`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	A205995-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205995-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205995-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205995-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205995-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205995-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205995-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205995-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205995-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205995-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205995-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205995-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205995-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205995-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205995-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205995-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205995-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205995-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205995-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205995-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205995-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205995-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205995-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205995-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205995-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205995-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205995-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205995-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205995-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205995-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205995-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205995-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205995-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205995-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205995-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205995-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205995-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205995-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205995-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205995-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: acamprosate calcium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACAMPROSATE CALCIUM	333 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
59375N1D0U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
835726	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
91769a96-3182-4e38-90c3-b22c1beae398	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
c95d5956-8a83-9dba-bb9d-d7b5fb3324ec	Product name	3	20170724
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70518-4616-0	acamprosate calcium	50 in 1 BOX	TABLET, DELAYED RELEASE	50		1
70518-4616-1	acamprosate calcium	1 in 1 POUCH	TABLET, DELAYED RELEASE	1		1

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
acamprosate calcium	ACAMPROSATE CALCIUM	REMEDYREPACK INC.	91769a96-3182-4e38-90c3-b22c1beae398	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205995 application number: ANDA205995 ndc (product): 70518-4616
acamprosate calcium	ACAMPROSATE CALCIUM	Zydus Pharmaceuticals (USA) Inc.	9803db35-2600-4f42-80c1-43216fd1ba3d	2023-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205995 application number: ANDA205995
acamprosate calcium	ACAMPROSATE CALCIUM	Zydus Lifesciences Limited	0c729939-d2d2-4e61-acbc-4f1646dc38c1	2023-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205995 application number: ANDA205995

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
59375N1D0U	ACAMPROSATE CALCIUM	77337-73-6	ACAMPROSATE CALCIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
835726	acamprosate calcium 333 MG Delayed Release Oral Tablet	PSN	91769a96-3182-4e38-90c3-b22c1beae398	1
835726	acamprosate calcium 333 MG Delayed Release Oral Tablet	SCD	91769a96-3182-4e38-90c3-b22c1beae398	1
835726	acamprosate calcium 333 MG (acamprosate 300 MG) Delayed Release Oral Tablet	SY	91769a96-3182-4e38-90c3-b22c1beae398	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4616-0	70518461600	50 POUCH in 1 BOX (70518-4616-0) / 1 TABLET, DELAYED RELEASE in 1 POUCH (70518-4616-1)	50 pouch	2026-04-23	No	No	Current
70518-4616-1	70518461601	1 in 1 POUCH					Historical