Acamprosate Calcium

Product NDC: 60687-121
11-digit product format: 606870121
Labeler code: 60687
Product ID: 60687-121_3d49a773-bfca-9870-e063-6294a90a2945
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acamprosate Calcium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: American Health Packaging
Application: ANDA202229
Marketing category: ANDA
Marketing start: 2015-10-27
Substance: ACAMPROSATE CALCIUM
Active strength: 333 mg/1
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202229-001	ACAMPROSATE CALCIUM	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202229-001	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	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2013-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL			2013-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL			2013-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL			2013-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL			2013-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL			2013-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL			2013-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL			2013-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202229-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202229-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202229-001	AB	1	`6a471c1ec25d…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202229-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202229-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202229-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202229-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202229-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202229-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202229-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202229-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202229-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202229-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202229-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202229-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202229-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202229-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202229-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202229-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202229-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202229-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202229-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202229-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202229-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202229-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202229-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202229-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202229-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202229-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202229-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202229-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202229-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202229-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202229-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Acamprosate Calcium
Listing expiration: 2026-12-31

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
94ef2a5c-cc2f-4e7f-b159-b2d38188d5b8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c95d5956-8a83-9dba-bb9d-d7b5fb3324ec	Product name	3	20170724

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60687-121-25	Acamprosate Calcium	30 in 1 BOX, UNIT-DOSE	TABLET, DELAYED RELEASE	30		11
60687-121-95	Acamprosate Calcium	1 in 1 BLISTER PACK	TABLET, DELAYED RELEASE	1		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-121-25	EA - Each	60687-121	5a0d39e1-dfa4-489d-9f2e-a2fffdccc4b4	1	2015-11-12
60687-121-95	EA - Each	60687-121	cde4e7a4-d807-4590-9d9c-1e76f499850d	1	2015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACAMPROSATE CALCIUM	ACTIVE INGREDIENT	59375N1D0U	ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	3
ACAMPROSATE	ACTIVE MOIETY	N4K14YGM3J	ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	3
MAGNESIUM SILICATE	INACTIVE INGREDIENT	9B9691B2N9	ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	3
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60687-121	ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	10	Current NDC, Legacy NDC, 2 package rows	20241003_94ef2a5c-cc2f-4e7f-b159-b2d38188d5b8.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acamprosate Calcium	ACAMPROSATE CALCIUM	Major Pharmaceuticals	ae6e79c0-a307-4888-b647-1b7be4cb9127	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202229 application number: ANDA202229
Acamprosate Calcium	ACAMPROSATE CALCIUM	Glenmark Pharmaceuticals Inc., USA	43e9ef60-2d85-4394-906b-93042fea099a	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202229 application number: ANDA202229
Acamprosate Calcium	ACAMPROSATE CALCIUM	American Health Packaging	94ef2a5c-cc2f-4e7f-b159-b2d38188d5b8	2025-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202229 application number: ANDA202229 ndc (product): 60687-121

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	94ef2a5c-cc2f-4e7f-b159-b2d38188d5b8	11
835726	acamprosate calcium 333 MG Delayed Release Oral Tablet	SCD	94ef2a5c-cc2f-4e7f-b159-b2d38188d5b8	11
835726	acamprosate calcium 333 MG (acamprosate 300 MG) Delayed Release Oral Tablet	SY	94ef2a5c-cc2f-4e7f-b159-b2d38188d5b8	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60687-121-25	60687012125	30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-121-25) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (60687-121-95)	30 blister pack	2015-10-27	0000-00-00	No	No	Current
60687-121-95	60687012195	1 in 1 BLISTER PACK						Historical