NDC 16837-855
PEPCID AC Maximum Strength
Famotidine
PEPCID AC Maximum Strength is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The primary component is Famotidine.
| Product ID | 16837-855_03eabe8f-7603-4cc8-93cf-a3b5b795ba51 |
| NDC | 16837-855 |
| Product Type | Human Otc Drug |
| Proprietary Name | PEPCID AC Maximum Strength |
| Generic Name | Famotidine |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2003-09-01 |
| Marketing Category | NDA / NDA |
| Application Number | NDA020325 |
| Labeler Name | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division |
| Substance Name | FAMOTIDINE |
| Active Ingredient Strength | 20 mg/1 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
Packaging
NDC 16837-855-05
1 BLISTER PACK in 1 CARTON (16837-855-05) > 5 TABLET, FILM COATED in 1 BLISTER PACK
| Marketing Start Date | 2003-09-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 16837-855-12 [16837085512]
PEPCID AC Maximum Strength TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA020325 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2003-09-01 |
NDC 16837-855-26 [16837085526]
PEPCID AC Maximum Strength TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA020325 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2003-09-01 |
| Marketing End Date | 2010-12-07 |
NDC 16837-855-70 [16837085570]
PEPCID AC Maximum Strength TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA020325 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2003-09-01 |
NDC 16837-855-49 [16837085549]
PEPCID AC Maximum Strength TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA020325 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2003-09-01 |
NDC 16837-855-08 [16837085508]
PEPCID AC Maximum Strength TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA020325 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2003-09-01 |
| Marketing End Date | 2015-04-27 |
NDC 16837-855-16 [16837085516]
PEPCID AC Maximum Strength TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA020325 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2003-09-01 |
NDC 16837-855-13 [16837085513]
PEPCID AC Maximum Strength TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA020325 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2003-09-01 |
NDC 16837-855-25 [16837085525]
PEPCID AC Maximum Strength TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA020325 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2003-09-01 |
| Marketing End Date | 2014-03-31 |
NDC 16837-855-17 [16837085517]
PEPCID AC Maximum Strength TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA020325 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2003-09-01 |
NDC 16837-855-67 [16837085567]
PEPCID AC Maximum Strength TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA020325 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2003-09-01 |
NDC 16837-855-51 [16837085551]
PEPCID AC Maximum Strength TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA020325 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2003-09-01 |
NDC 16837-855-09 [16837085509]
PEPCID AC Maximum Strength TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA020325 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2003-09-01 |
NDC 16837-855-85 [16837085585]
PEPCID AC Maximum Strength TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA020325 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2003-09-01 |
NDC 16837-855-18 [16837085518]
PEPCID AC Maximum Strength TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA020325 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2003-09-01 |
NDC 16837-855-11 [16837085511]
PEPCID AC Maximum Strength TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA020325 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2003-09-01 |
| Marketing End Date | 2010-12-07 |
NDC 16837-855-80 [16837085580]
PEPCID AC Maximum Strength TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA020325 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2003-09-01 |
NDC 16837-855-52 [16837085552]
PEPCID AC Maximum Strength TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA020325 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2003-09-01 |
NDC 16837-855-65 [16837085565]
PEPCID AC Maximum Strength TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA020325 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2003-09-01 |
NDC 16837-855-20 [16837085520]
PEPCID AC Maximum Strength TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA020325 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2014-08-22 |
NDC 16837-855-15 [16837085515]
PEPCID AC Maximum Strength TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA020325 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2003-09-01 |
NDC 16837-855-40 [16837085540]
PEPCID AC Maximum Strength TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA020325 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2003-09-01 |
NDC 16837-855-19 [16837085519]
PEPCID AC Maximum Strength TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA020325 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2015-04-27 |
NDC 16837-855-28 [16837085528]
PEPCID AC Maximum Strength TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA020325 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2003-09-01 |
| Marketing End Date | 2015-12-15 |
NDC 16837-855-50 [16837085550]
PEPCID AC Maximum Strength TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA020325 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2003-09-01 |
NDC 16837-855-75 [16837085575]
PEPCID AC Maximum Strength TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA020325 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2003-09-01 |
NDC 16837-855-05 [16837085505]
PEPCID AC Maximum Strength TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA020325 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2003-09-01 |
NDC 16837-855-42 [16837085542]
PEPCID AC Maximum Strength TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA020325 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2003-09-01 |
| Marketing End Date | 2010-12-07 |
NDC 16837-855-14 [16837085514]
PEPCID AC Maximum Strength TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA020325 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2003-09-01 |
NDC 16837-855-64 [16837085564]
PEPCID AC Maximum Strength TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA020325 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2003-09-01 |
| Marketing End Date | 2015-12-15 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| FAMOTIDINE | 20 mg/1 |
OpenFDA Data
| SPL SET ID: | 2854047f-c5c4-43c3-8ef2-5c0a84a307f2 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
NDC Crossover Matching brand name "PEPCID AC Maximum Strength" or generic name "Famotidine"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 16837-855 | PEPCID AC Maximum Strength | PEPCID AC Maximum Strength |
| 0363-0141 | Acid Controller | Famotidine |
| 0363-0701 | Acid Controller | Famotidine |
| 0363-1203 | acid controller | famotidine |
| 0113-7141 | basic care acid reducer | Famotidine |
| 0113-7194 | Basic Care famotidine | Famotidine |
| 0093-2748 | Famotidine | Famotidine |
| 0172-5728 | Famotidine | Famotidine |
| 0172-5729 | Famotidine | Famotidine |
| 0338-5197 | Famotidine | Famotidine |
| 0363-0036 | Famotidine | Famotidine |
| 0363-1899 | Famotidine | Famotidine |
| 0113-0141 | good sense acid reducer | Famotidine |
| 0113-0194 | Good Sense Acid Reducer | Famotidine |
| 0187-4420 | Pepcid | famotidine |
| 0187-4440 | Pepcid | famotidine |
Trademark Results [PEPCID AC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PEPCID AC 74565086 1984651 Live/Registered |
JOHNSON & JOHNSON 1994-08-24 |
 PEPCID AC 74242973 1812672 Dead/Cancelled |
MERCK & CO., Inc. 1992-02-03 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.