Acamprosate Calcium

Product NDC: 0378-6333
11-digit product format: 003786333
Labeler code: 0378
Product ID: 0378-6333_e06868f1-f40b-4762-bd52-53a5ba825619
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: acamprosate calcium enteric-coated
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA200142
Marketing category: ANDA
Marketing start: 2014-09-24
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
A200142-001	ACAMPROSATE CALCIUM	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2014-03-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200142-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200142-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-03-11	`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	A200142-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200142-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200142-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200142-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200142-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200142-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200142-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200142-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200142-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200142-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200142-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200142-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200142-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200142-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200142-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200142-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200142-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200142-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200142-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200142-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200142-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200142-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200142-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200142-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200142-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200142-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200142-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200142-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200142-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200142-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200142-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200142-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200142-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200142-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200142-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200142-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200142-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200142-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200142-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200142-001	AB	1	`cb3db0bc1861…`

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
75ddfd10-55b2-426e-bc74-3413cd0d7c94	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
0378-6333-80	Acamprosate Calcium	180 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	180		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-6333-80	EA - Each	0378-6333	6eeea4d4-e974-490e-9718-abc891d97717	1	2014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACAMPROSATE CALCIUM	ACTIVE INGREDIENT	59375N1D0U	ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	5
ACAMPROSATE	ACTIVE MOIETY	N4K14YGM3J	ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	5
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	5
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	5
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	5
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	5
ACAMPROSATE CALCIUM	ACTIVE INGREDIENT	59375N1D0U	ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1
ACAMPROSATE	ACTIVE MOIETY	N4K14YGM3J	ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-6333	ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	12	Current NDC, Legacy NDC, 1 package rows	20250115_75ddfd10-55b2-426e-bc74-3413cd0d7c94.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acamprosate Calcium	ACAMPROSATE CALCIUM ENTERIC-COATED	NCS HealthCare of KY, LLC dba Vangard Labs	f2bf6742-4b85-45e2-8daa-0f9bfc75a128	2025-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200142 application number: ANDA200142
Acamprosate Calcium	ACAMPROSATE CALCIUM ENTERIC-COATED	Mylan Pharmaceuticals Inc.	75ddfd10-55b2-426e-bc74-3413cd0d7c94	2022-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200142 application number: ANDA200142 ndc (product): 0378-6333

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	75ddfd10-55b2-426e-bc74-3413cd0d7c94	12
835726	acamprosate calcium 333 MG Delayed Release Oral Tablet	SCD	75ddfd10-55b2-426e-bc74-3413cd0d7c94	12
835726	acamprosate calcium 333 MG (acamprosate 300 MG) Delayed Release Oral Tablet	SY	75ddfd10-55b2-426e-bc74-3413cd0d7c94	12
835726	acamprosate calcium 333 MG Delayed Release Oral Tablet	PSN	f2bf6742-4b85-45e2-8daa-0f9bfc75a128	1
835726	acamprosate calcium 333 MG Delayed Release Oral Tablet	SCD	f2bf6742-4b85-45e2-8daa-0f9bfc75a128	1
835726	acamprosate calcium 333 MG (acamprosate 300 MG) Delayed Release Oral Tablet	SY	f2bf6742-4b85-45e2-8daa-0f9bfc75a128	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-6333-80	00378633380	180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6333-80)	2014-09-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acamprosate Calcium	NCS HealthCare of KY, LLC dba Vangard Labs	2025-02-20	HUMAN PRESCRIPTION DRUG LABEL	2
Acamprosate Calcium	Mylan Pharmaceuticals Inc.	2022-11-17	HUMAN PRESCRIPTION DRUG LABEL	12
Acamprosate Calcium	Mylan Institutional Inc.	2020-06-05	HUMAN PRESCRIPTION DRUG LABEL	6